Latest Industry News & Trends

Market Scope provides comprehensive coverage of the ophthalmic market. Our news stories are a combination of public and proprietary content ranging from coverage of international meetings, surgeon survey results and trends, analysis of company financial reports and public medical registries, press releases, and interviews with executives. Register today to receive free weekly email updates, our top data chart, surgeon poll results, and much more. Locked content can be accessed through a subscription to our ophthalmic industry newsletters.

Breaking News

12/6/2024
BreakingEuropeIOLPresbyopiaRefractiveSurgical
Ophtec Receives CE Marking for Artiplus Phakic IOL, Targets Young Presbyopes
Ophtec Receives CE Marking for Artiplus Phakic IOL, Targets Young Presbyopes

Dutch company Ophtec announced Nov. 18 that it had gained CE Mark approval for its Artiplus phakic intraocular lens (IOL). The company said the lens offered a solution for relatively young presbyop...

12/6/2024
BreakingClinical TrialPharmaRegulationRetina
Outlook’s Lytenava Misses Endpoint vs. Ranibizumab in Topline Results
Outlook’s Lytenava Misses Endpoint vs. Ranibizumab in Topline Results

Outlook Therapeutics reported Nov. 27 that its ophthalmic bevacizumab candidate Lytenava (ONS-5010) did not meet its non-inferiority endpoint in topline results from the NORSE EIGHT trial vs. ranib...

12/6/2024
BreakingPharmaRegulationRetina
US FDA Rejects sNDA for Izervay Seeking Every-Other-Month Dosing
US FDA Rejects sNDA for Izervay Seeking Every-Other-Month Dosing

Japan’s Astellas Pharma announced Nov. 19 that the US FDA had issued a complete response letter rejecting its supplemental new drug application (sNDA) for Izervay seeking to expand the drug’s label...

12/6/2024
BreakingDiagnosticGlaucomaPerimetry
Konan Medical Launches ObjectiveField Perimeter in US
Konan Medical Launches ObjectiveField Perimeter in US

Konan Medical has launched its ObjectiveField visual field analyzer in the US. The ObjectiveField is an objective perimeter designed to detect visual field abnormalities using pupillary responses. ...

12/6/2024
BreakingEuropeGene TherapyRegulationRetina
EU Grants Orphan Drug Status to Ocugen’s Gene Therapy Candidate for ABCA4-Associated Retinopathies
EU Grants Orphan Drug Status to Ocugen’s Gene Therapy Candidate for ABCA4-Associated Retinopathies

Ocugen announced Nov. 20 that the European Medicines Agency had granted orphan medicinal product status for OCU410ST, a gene therapy candidate targeting ABCA4-associated retinopathies, including St...

12/6/2024
AIBreakingDealsDiagnosticFundusGlaucomaRetina
Avant, Ainnova Advancing Low-Cost Retinal Camera with AI Screening Software
Avant, Ainnova Advancing Low-Cost Retinal Camera with AI Screening Software

Nevada-based Avant Technologies and Ainnova Tech, of Houston, Texas, announced Nov. 20 that the two companies would advance Ainnova’s proprietary low-cost retinal camera packaged with the Vision AI...

11/27/2024
BreakingGlaucomaLaserMIGSRegulationSurgical
MACs Finalize Coverage for Standalone and Combo MIGS Procedures
MACs Finalize Coverage for Standalone and Combo MIGS Procedures

Five Medicare administrative contractors have issued their final coverage policies for minimally invasive glaucoma surgery, or MIGS, along with more technical billing and coding documents. The poli...

11/27/2024
AllergyBreakingCataractDry EyePharma
Harrow Lowers Price of Drugs through GoodRx Partnership, Price Cuts
Harrow Lowers Price of Drugs through GoodRx Partnership, Price Cuts

Harrow, of Nashville, Tennessee reported Nov. 13 that it had entered into a partnership with GoodRx to provide patients without insurance or for whom insurance is not a viable option a cash-pay alt...

11/27/2024
BreakingEuropeGene TherapyRegulationRetina
GenSight Submits Updated Data on Lumevoq to Restart Early Access Program in France
GenSight Submits Updated Data on Lumevoq to Restart Early Access Program in France

Paris-based GenSight Biologics announced Nov. 13 that it had submitted an updated regulatory file for Lumevoq, its gene therapy candidate for Leber hereditary optic neuropathy (LHON), to French reg...

11/27/2024
BreakingDeviceDry EyeRegulation
US FDA Clears Tixel i Dry Eye and MGD Treatment Device from Novoxel
US FDA Clears Tixel i Dry Eye and MGD Treatment Device from Novoxel

Israel’s Novoxel announced Nov. 19 that the US FDA had granted 510(k) clearance to the Tixel i treatment device for evaporative dry eye and meibomian gland dysfunction. The company said the device ...

11/27/2024
BreakingClinical TrialGlaucomaPharma
Nicox Chooses Higher Dose of NCX 470 to Advance in Phase III Glaucoma Trials
Nicox Chooses Higher Dose of NCX 470 to Advance in Phase III Glaucoma Trials

France’s Nicox announced Nov. 19 that it had chosen the higher dose of NCX 470 ophthalmic solution to advance in the Phase III Mont Blanc trial in glaucoma. The company said both doses tested—0.065...

11/27/2024
BreakingDealsGene TherapyRetina
Atsena Licenses LCA1 Gene Therapy Candidate to Nippon Shinyaku for US, Japan
Atsena Licenses LCA1 Gene Therapy Candidate to Nippon Shinyaku for US, Japan

Atsena Therapeutics announced Nov. 13 that it had granted exclusive commercial rights for its Leber congenital amaurosis type 1 (LCA1) gene therapy candidate ATSN-101 to Nippon Shinyaku in the US a...

11/27/2024
BreakingPharmaRegulationRetina
US FDA Grants Rare Pediatric, Fast Track Status to Alkeus’ Stargardt Candidate
US FDA Grants Rare Pediatric, Fast Track Status to Alkeus’ Stargardt Candidate

Alkeus Pharmaceuticals announced Nov. 18 that the US FDA had granted rare pediatric disease and fast track designations to gildeuretinol (ALK-001), its oral therapy candidate for Stargardt disease....

11/22/2024
BreakingCataractGlaucomaLaserRegulationRetinaSurgical
CMS Cuts Ophthalmologists’ Procedure Fees, While Raising ASC, HOPD Facility Fees
CMS Cuts Ophthalmologists’ Procedure Fees, While Raising ASC, HOPD Facility Fees

The Centers for Medicare and Medicaid Services (CMS) published on Nov. 1 the final schedule of Medicare reimbursement fees for physicians in 2025. It also released its facility fee payments for ASC...

11/22/2024
BiosimilarsBreakingPatentRegulationRetina
Amgen Launches Eylea Biosimilar Pavblu After Court Win Over Regeneron
Amgen Launches Eylea Biosimilar Pavblu After Court Win Over Regeneron

Amgen has launched its Eylea biosimilar, Pavblu (aflibercept-ayyh), after a victory in October in its patent fight with Regeneron. Fierce Pharma reported that a trio of US circuit judges on Oct. 22...

11/22/2024
BreakingCataractGlaucomaPharmaRegulation
Harrow’s ImprimisRx Unit Gets $34.9 Million Trademark Infringement Verdict
Harrow’s ImprimisRx Unit Gets $34.9 Million Trademark Infringement Verdict

Harrow’s ImprimisRx subsidiary received a $34.9 million verdict on Nov. 20, 2024, in a trademark infringement lawsuit against OSRX Pharmaceuticals, of Missoula, Montana. OSRX is an affiliate of Ocu...

11/22/2024
BreakingCataractDry EyeLaserOcular CancerRevenue
Q3-2024 Ophthalmic Revenue Roundup for Immunocore, Harrow, Tarsus, Lumibird, and Ocular Therapeutix
Q3-2024 Ophthalmic Revenue Roundup for Immunocore, Harrow, Tarsus, Lumibird, and Ocular Therapeutix

UK-headquartered Immunocore reported Nov. 6 that its Q3-2024 net revenue from Kimmtrak (tebentafusp) was $80.2 million, a 28 percent increase over $62.6 million in Q3-2023. Regionally, Kimmtrak net...

11/22/2024
BiosimilarsBreakingEuropeRegulationRetina
Samsung Bioepis, Biogen Gain EU Approval for Aflibercept Biosimilar Known as Opuviz
Samsung Bioepis, Biogen Gain EU Approval for Aflibercept Biosimilar Known as Opuviz

Korea’s Samsung Bioepis and Biogen, of Cambridge, Massachusetts, announced Nov. 18 that the European Commission had granted marketing authorization for Opuviz (aflibercept-yszy), an Eylea biosimila...

11/22/2024
BreakingDry EyeRegulation
US FDA Accepts NDA for Aldeyra’s Reproxalap in Dry Eye
US FDA Accepts NDA for Aldeyra’s Reproxalap in Dry Eye

Aldeyra Therapeutics announced Nov. 18 that the US FDA had accepted for review the company’s resubmitted new drug application (NDA) for topical ocular reproxalap for dry eye. The FDA assigned a Pre...

11/22/2024
BreakingClinical TrialGene TherapyRetina
MeiraGTx to Submit UK Marketing Application for LCA4 Candidate Under ‘Exceptional Circumstances’
MeiraGTx to Submit UK Marketing Application for LCA4 Candidate Under ‘Exceptional Circumstances’

MeiraGTx, with offices in London and New York, announced Nov. 13 that it would submit a marketing authorization application in the UK under “exceptional circumstances” for AAV-AIPL1, its gene thera...

11/15/2024
BreakingClinical TrialMyopia
Eyenovia Scraps Phase III Study of Low-Dose Atropine in Myopia After Endpoint Missed
Eyenovia Scraps Phase III Study of Low-Dose Atropine in Myopia After Endpoint Missed

Eyenovia reported Nov. 15 that it would scrap the Phase III CHAPERONE trial of low-dose atropine in pediatric myopia after an independent data review committee determined that the trial is not meet...

11/15/2024
BiosimilarsBreakingEuropeRegulationRetina
Sandoz Gains EU Approval for its Aflibercept Biosimilar Known as Afqlir
Sandoz Gains EU Approval for its Aflibercept Biosimilar Known as Afqlir

Swiss drugmakerSandoz announced Nov. 15 that the European Commission had granted marketing authorization for Afqlir (aflibercept), an Eylea biosimilar. Afqlir, available as a 2 mg vial kit and pre-...

11/15/2024
BreakingCataractChinaDry EyeGlaucomaIOLLaserRevenueSurgical
Q3-2024 Ophthalmic Revenue Roundup for Alcon, Hoya, RxSight, Sight Sciences, and Iridex
Q3-2024 Ophthalmic Revenue Roundup for Alcon, Hoya, RxSight, Sight Sciences, and Iridex

Alcon reported Nov. 12 that its Q3-2024 net sales totaled $2.4 billion, a 6 percent increase over $2.3 billion in Q3-2023. Surgical net sales for implantables, consumables, and equipment/other were...

11/15/2024
BreakingDealsRetina
Kalaris Will Merge with AlloVir and Advance Candidate for Exudative Retinal Disease
Kalaris Will Merge with AlloVir and Advance Candidate for Exudative Retinal Disease

Kalaris Therapeutics announced Nov. 8 that it would merge with biotech company AlloVir in an all-stock transaction to advance Kalaris’ next-generation anti-VEGF candidate TH103 for exudative retina...

11/15/2024
BreakingDealsOcular Cancer
Advancium Signs Option to License Retinoblastoma Candidate from Aileron
Advancium Signs Option to License Retinoblastoma Candidate from Aileron

Aileron Therapeutics and Advancium Health Network announced Oct. 31 an exclusive option agreement for Advancium to acquire ALRN-6924, a clinical-stage oncology agent developed by Aileron prior to i...

11/15/2024
BreakingChinaDealsRetina
Arctic Vision Licenses Chinese Rights for Xipere to Santen for $85 Million
Arctic Vision Licenses Chinese Rights for Xipere to Santen for $85 Million

Clearside Biomedical’s Asia-Pacific partner, Arctic Vision, announced Nov. 7 that it had licensed Chinese commercialization rights for ARVN001, marketed in the US as Xipere, to Santen Pharmaceutica...

11/15/2024
BreakingRegulationRetina
US FDA Grants Fast Track Designation to Feliqs’ ROP Candidate
US FDA Grants Fast Track Designation to Feliqs’ ROP Candidate

Japanese biopharmaceutical company Feliqs announced Nov. 1 that the US FDA had granted its lead asset, FLQ-101, fast track designation for the prevention of retinopathy of prematurity (ROP). FLQ-10...

11/8/2024
BreakingCataractEuropeGlaucomaIndiaIndustryMeetingNewsletterRefractiveRetina
2025-2026 Ophthalmic Meetings Calendar
2025-2026 Ophthalmic Meetings Calendar

Market Scope regularly updates its list of ophthalmic meetings to keep the information current. Please contact us at matthewdouty@market-scope.com if we do not have your meeting listed. Thank you.

11/8/2024
BreakingDeviceRegulationRetina
US FDA Grants De Novo Classification to LumiThera’s Photobiomodulation System for Dry AMD
US FDA Grants De Novo Classification to LumiThera’s Photobiomodulation System for Dry AMD

LumiThera announced Nov. 4 that the US FDA had granted market authorization through the de novo pathway for the Valeda photobiomodulation system for treatment of patients with dry age-related macul...

11/8/2024
BreakingCataractCornealDry EyeGlaucomaLaserPharmaPresbyopiaRefractiveRetinaRevenueSurgical
Q3-2024 Ophthalmic Revenue Roundup for AbbVie, Apellis, Glaukos, STAAR, and Lensar
Q3-2024 Ophthalmic Revenue Roundup for AbbVie, Apellis, Glaukos, STAAR, and Lensar

AbbVie, of North Chicago, Illinois, reported Oct. 30 that its Q3-2024 eye care net revenue was $525 million, a 13.5 percent decline (-11.2 percent cc) from $605 million in Q3-2023. Restasis revenue...

11/8/2024
BreakingDealsDry Eye
NovaBay Accepts Higher Offer from PRN to Purchase Assets
NovaBay Accepts Higher Offer from PRN to Purchase Assets

NovaBay reported Nov. 6 that it had accepted a higher offer from PRN Physician Recommended Nutriceuticals, LLC, which revised its bid for NovaBay’s Avenova product line after a competing overture f...

11/8/2024
BreakingRegulationRetina
US FDA Asks for Added Data on Neurotech MacTel Candidate, Pushes Back PDUFA Date
US FDA Asks for Added Data on Neurotech MacTel Candidate, Pushes Back PDUFA Date

Neurotech Pharmaceuticals announced Nov. 8 that it had submitted additional data requested by the US FDA to support its biologic license application (BLA) for NT-501, an encapsulated cell therapy i...

11/8/2024
BreakingChinaGene TherapyRegulationRetina
US FDA Gives Green Light to Phase I Trial of HuidaGene’s CRISPR RNA-Editing Candidate for Wet AMD
US FDA Gives Green Light to Phase I Trial of HuidaGene’s CRISPR RNA-Editing Candidate for Wet AMD

HuidaGene Therapeutics announced Nov. 4 that the US FDA had cleared its investigational new drug (IND) application for a Phase I trial of HG202, a gene therapy candidate targeting wet age-related m...

11/8/2024
BreakingCataractDealsEuropePharma
DÁVI Licenses Clobetasol Propionate Post-op Drops from Formosa for Portugal
DÁVI Licenses Clobetasol Propionate Post-op Drops from Formosa for Portugal

Taiwan-based Formosa Pharmaceuticals announced Oct. 31 that it had entered into an exclusive licensing agreement with DÁVI Farmacêutica, of Portugal, for the rights there to market clobetasol propi...

11/8/2024
BreakingDry EyeIndustry
Tarsus Appoints Elizabeth Yeu, MD, as Chief Medical Officer
Tarsus Appoints Elizabeth Yeu, MD, as Chief Medical Officer

Tarsus Pharmaceuticals, maker of Xdemvy for Demodex blepharitis, announced Nov. 5 that it had appointed Elizabeth Yeu, MD, as chief medical officer. Yeu had served as Tarsus’ chief medical advisor ...

11/1/2024
BreakingEuropePharmaRegulationRetina
Astellas Withdraws EU Marketing Application for Avacincaptad Pegol in GA
Astellas Withdraws EU Marketing Application for Avacincaptad Pegol in GA

Japan’s Astellas Pharma announced Oct. 28 that it had withdrawn its marketing authorization application in the EU for avacincaptad pegol, a complement-5 inhibitor targeting geographic atrophy (GA) ...

11/1/2024
BreakingIOLPharmaRetinaRevenue
Q3-2024 Ophthalmic Revenue Roundup for Regeneron, Bausch + Lomb, and Novartis
Q3-2024 Ophthalmic Revenue Roundup for Regeneron, Bausch + Lomb, and Novartis

Regeneron of Tarrytown, New York, reported Oct. 31 that its Q3-2024 US revenue for Eylea (aflibercept) 2 mg and Eylea HD (a higher dose of aflibercept at 8 mg) was $1.54 billion, a 3 percent increa...

11/1/2024
BreakingPharmaRetinaStudy
Vabysmo Improved Vision in Underrepresented Populations with DME in Elevatum Study
Vabysmo Improved Vision in Underrepresented Populations with DME in Elevatum Study

Genentech, a member of the Roche Group, announced Oct. 18 positive topline one-year results from the postmarket Elevatum study evaluating Vabysmo (faricimab-svoa) for the treatment of diabetic macu...

11/1/2024
BreakingDeviceRegulation
Michelle Tarver, MD, PhD, an Ophthalmologist, Named Director of FDA’s CDRH
Michelle Tarver, MD, PhD, an Ophthalmologist, Named Director of FDA’s CDRH

Michelle E. Tarver, MD, PhD, has been named director of the FDA’s Center for Devices and Radiological Health (CDRH), after serving as acting director since July 2024. She is a board-certified ophth...

11/1/2024
BreakingDealsDry Eye
NovaBay Receives Higher Asset Purchase Bid from RVL-Affiliated Company
NovaBay Receives Higher Asset Purchase Bid from RVL-Affiliated Company

NovaBay reported Oct. 29 that it had received a better offer for its assets than the one it had accepted from PRN Physician Recommended Nutriceuticals, LLC. NovaBay’s board determined that the unso...

11/1/2024
BreakingClinical TrialPharmaRetina
Alkeus’ Oral Gildeuretinol for GA Shows Positive Topline Results in Phase III
Alkeus’ Oral Gildeuretinol for GA Shows Positive Topline Results in Phase III

Alkeus Pharmaceuticals reported positive topline results on Oct. 23 from the Phase III SAGA trial of gildeuretinol acetate (ALK-001), a once-daily oral therapy candidate targeting geographic atroph...

11/1/2024
BreakingFundingPharmaRetina
RevOpsis Awarded $1.8 Million NEI Grant to Advance Retinal Candidate RO-104
RevOpsis Awarded $1.8 Million NEI Grant to Advance Retinal Candidate RO-104

RevOpsis Therapeutics announced Oct. 15 that it had been awarded a Small Business Innovation Research grant of $1.8 million from the National Eye Institute (NEI) to advance lead asset RO-104 for ex...

11/1/2024
BreakingDealsPharmaRetina
Korean Companies GC Biopharma, Novelty Nobility to Collaborate on GA Drug Discovery
Korean Companies GC Biopharma, Novelty Nobility to Collaborate on GA Drug Discovery

South Korean companies GC Biopharma and Novelty Nobility announced Oct. 28 that they would jointly research and develop a novel treatment candidate for geographic atrophy (GA). The companies said a...

10/25/2024
BreakingPharmaRetina
Pine Pharmaceuticals Stops Compounding IVT Avastin, Creating Concerns Over Shortage
Pine Pharmaceuticals Stops Compounding IVT Avastin, Creating Concerns Over Shortage

Pine Pharmaceuticals, of Tonawanda, New York, stopped repackaging Avastin (bevacizumab) for ophthalmic use in October 2024, according to the American Academy of Ophthalmology and American Society o...

10/25/2024
BreakingIOLPharmaRetinaRevenueSurgical
Q3-2024 Ophthalmic Revenue Roundup for Roche and J&J Vision
Q3-2024 Ophthalmic Revenue Roundup for Roche and J&J Vision

Swiss company Roche reported Oct. 23 that Q3-2024 Vabysmo sales were CHF 1 billion ($1.15 billion, converted on Oct. 23, 2024), a 59 percent increase over CHF 656 million in Q3-2023. The company sa...

10/25/2024
BreakingPresbyopiaRegulation
US FDA Accepts NDA For Lenz’ Presbyopia Drop Candidate
US FDA Accepts NDA For Lenz’ Presbyopia Drop Candidate

Lenz Therapeutics announced Oct. 21 that the US FDA had accepted its new drug application (NDA) for LNZ100, a once-daily, preservative-free eye drop candidate for presbyopia. The FDA assigned a Pre...

10/25/2024
BreakingDealsGene TherapyPresbyopiaRefractiveRetina
Ocuphire Pharma Acquires Opus Genetics, Will Operate Under Opus Name
Ocuphire Pharma Acquires Opus Genetics, Will Operate Under Opus Name

Ocuphire Pharma announced Oct. 22 that it would acquire Opus Genetics in an all-stock transaction. The combined company will operate under the Opus name and will trade on the Nasdaq under the ticke...

10/25/2024
BreakingDiagnosticDry EyeFundingStudy
ARPA-H Seeks Proposals for Tear Duct-Based Diagnostic System, Plus Custom Dosing Platform
ARPA-H Seeks Proposals for Tear Duct-Based Diagnostic System, Plus Custom Dosing Platform

ARPA-H announced Oct. 18 that it had launched a new program to develop a tear-based biomarker measurement system that can be inserted into the tear duct to provide continuous health monitoring, pai...

10/25/2024
BreakingClinical TrialLow VisionProsthesisRetina
Preliminary Results Show Prima Implant Allows for Functional Vision in Advanced GA Patients
Preliminary Results Show Prima Implant Allows for Functional Vision in Advanced GA Patients

Science Corporation, of Alameda, California, reported Oct. 22 preliminary results that showed its Prima retinal implant allowed for functional vision in patients who had lost their central visual f...

10/25/2024
BreakingCornealDealsDry EyeFundingStudy
Grifols, BARDA Partner on Ocular Immunoglobulin Drops for Sulfur Mustard Exposure
Grifols, BARDA Partner on Ocular Immunoglobulin Drops for Sulfur Mustard Exposure

Barcelona-basedGrifols reported Oct. 22 that it is partnering with the US government’s BARDA to test ocular surface immunoglobulin (OSIG) eye drops for their ability to treat ocular damage from sul...

10/25/2024
BreakingInstrumentsSingle-UseSurgical
Corza Launches Onatec Ophthalmic Microsurgical Suture Portfolio
Corza Launches Onatec Ophthalmic Microsurgical Suture Portfolio

Corza Medical, of Westwood, Massachusetts, reported Oct. 21 that it had launched its Onatec ophthalmic microsurgical suture portfolio of needles and suture material. The company said Onatec needles...

10/18/2024
BreakingCataractIOLRegulationSurgical
Bausch + Lomb Gains US FDA Approval of enVista Envy Trifocal IOL
Bausch + Lomb Gains US FDA Approval of enVista Envy Trifocal IOL

Bausch + Lomb reported Oct. 14 that the US FDA had approved itsenVista Envy trifocal intraocular lens. The lens is available on a limited basis in the US and will be launched more broadly in 2025. ...

10/18/2024
BreakingGlaucomaPharma
Spinogenix Unveils Glaucoma Program to Evaluate Once-Daily Neuroprotective Pill
Spinogenix Unveils Glaucoma Program to Evaluate Once-Daily Neuroprotective Pill

Los Angeles-based Spinogenix reported Oct. 16 that it was launching a program to evaluate SPG302 as a potential neuroprotective therapeutic for glaucoma. Spinogenix describes SPG302 as a once-a-day...

10/18/2024
AAOAIBreakingDiagnosticRetinaSurgical
Eyenuk, AAO Collaborate to Offer AI-Driven DR Screening for Underserved Patients in Delaware
Eyenuk, AAO Collaborate to Offer AI-Driven DR Screening for Underserved Patients in Delaware

Eyenuk and the American Academy of Ophthalmology (AAO) reported Oct. 16 that they had teamed up under the AAO’s EyeCare America program to provide eye disease screening for underserved communities ...

10/18/2024
BreakingDiagnosticOCTRegulation
US FDA Grants 510(k) Clearance to Flex Module for Heidelberg Spectralis OCT
US FDA Grants 510(k) Clearance to Flex Module for Heidelberg Spectralis OCT

Heidelberg Engineering announced Oct. 14 that the US FDA had granted 510(k) clearance to its Flex Module for the Spectralis diagnostic imaging platform. The Flex Module mounts the Spectralis to a m...

10/18/2024
BreakingDealsPharmaPresbyopia
Orasis Licenses Qlosi Presbyopia Drops to Optus in Korea for $18 Million, Plus Royalties
Orasis Licenses Qlosi Presbyopia Drops to Optus in Korea for $18 Million, Plus Royalties

Orasis Pharmaceuticals announced Oct. 16 that it had licensed its Qlosi presbyopia drops to Optus Pharmaceuticals for the Korean market. Under the deal, Optus will pay upfront and milestone payment...

10/18/2024
BreakingDealsGlaucomaPharma
Nicox and Soleus Sign $16.5 Million Deal for Vyzulta Royalties, Equity Financing
Nicox and Soleus Sign $16.5 Million Deal for Vyzulta Royalties, Equity Financing

France’s Nicox announced Oct. 14 a deal with Soleus Capital under which Soleus will acquire Nicox’ royalties from the glaucoma treatment Vyzulta for $15 million, while providing $1.5 million in equ...

10/18/2024
BreakingCataractCornealSurgical
Cure Blindness Project Expands Sight-Saving Care to Six New Countries
Cure Blindness Project Expands Sight-Saving Care to Six New Countries

Cure Blindness Project is expanding to six new countries—Burundi, Democratic Republic of the Congo, Liberia, Pakistan, Paraguay, and Zambia, the charity reported Oct. 10. Paraguay marksthe charity’...

10/18/2024
BreakingCataractFLACSSurgical
Lensar Marks 1 Million Procedures Using its Femtosecond Cataract Lasers
Lensar Marks 1 Million Procedures Using its Femtosecond Cataract Lasers

Lensar reported Oct. 8 that surgeons had performed more than 1 million procedures using its Lensar femtosecond cataract systems. The Orlando, Florida, company introduced its original Lensar Laser S...

10/18/2024
BreakingOcular CancerRegulation
EU Grants Orphan Drug Status to Theriva’s Retinoblastoma Candidate
EU Grants Orphan Drug Status to Theriva’s Retinoblastoma Candidate

Theriva Biologics, of Rockville, Maryland, announced Oct. 16 that the European Commission had granted orphan medicinal product designation for VCN-01, its treatment candidate for retinoblastoma. VC...

10/11/2024
BreakingDry EyeRegulation
Aldeyra Resubmits NDA for Reproxalap in Dry Eye
Aldeyra Resubmits NDA for Reproxalap in Dry Eye

Aldeyra Therapeutics announced Oct. 3 that it had resubmitted its new drug application (NDA) to the US FDA for topical ocular reproxalap in dry eye. The US FDA issued a complete response letter in ...

10/11/2024
BreakingGene TherapyRegulationRetina
Nanoscope Plans to Submit BLA for Optogenetic RP Candidate in Q1-2025
Nanoscope Plans to Submit BLA for Optogenetic RP Candidate in Q1-2025

Nanoscope Therapeutics announced Oct. 10 that it had met with the US FDA regarding MCO-010, an ambient-light-activatable optogenetic monotherapy to restore vision in patients with advanced retiniti...

10/11/2024
BreakingRefractiveRegulationSurgical
FTC Sends More Than $1.1 Million to Consumers Misled by LCA-Vision Ads
FTC Sends More Than $1.1 Million to Consumers Misled by LCA-Vision Ads

The Federal Trade Commission (FTC) announced Oct. 3 that it was sending more than $1.1 million in settlement payments to consumers who were misled by deceptive bait-and-switch advertising by LCA-Vi...

10/11/2024
BreakingCataractClinical TrialIOLRegulation
Rayner Begins US Study of RayOne Galaxy Trifocal Spiral IOL
Rayner Begins US Study of RayOne Galaxy Trifocal Spiral IOL

UK-based Rayner reported Oct. 1 that the first RayOne Galaxy lenses had been implanted in the US as part of an FDA investigational device exemption (IDE) study. Rayner describes the Galaxy, a trifo...

10/11/2024
BreakingClinical TrialRegulationRetina
US FDA Removes Clinical Hold on Ocugen’s IND for OCU200 in DME
US FDA Removes Clinical Hold on Ocugen’s IND for OCU200 in DME

Ocugen announced Oct. 9 that the US FDA had lifted its clinical hold on the investigational new drug (IND) application for a Phase I trial of OCU200, a recombinant fusion protein consisting of tums...

10/11/2024
BreakingDiagnosticMicroscopes
Beyeonics One Introduces ‘Invisible Light’ Infrared Illumination
Beyeonics One Introduces ‘Invisible Light’ Infrared Illumination

Israel’s Beyeonics Vision announced Oct. 8 that it had incorporated “invisible light” technology, based on infrared night vision, into the Beyeonics One surgical visualization system. Beyeonics sai...

10/11/2024
BreakingDiagnosticGlaucoma
iCare Launches ST500 Slit Lamp Mounted Rebound Tonometer
iCare Launches ST500 Slit Lamp Mounted Rebound Tonometer

Finland’s iCare, a subsidiary of Revenio Group, has launched its iCare ST500 rebound tonometer that can be attached to a slit lamp. The device gained US FDA 510(k) clearance on Sept. 27. The compan...

10/11/2024
BreakingGlaucomaIndustryLaserRetina
Iridex Appoints Patrick Mercer as Chief Executive Officer
Iridex Appoints Patrick Mercer as Chief Executive Officer

Iridex reported Oct. 3 that it had appointed Patrick Mercer as chief executive officer, to go along with his role as president, effective Oct. 1. Mercer had also served as the company’s chief opera...

10/11/2024
BreakingIndustryRetina
Opthea Appoints Parisa Zamiri, MD, PhD, as Chief Medical Officer
Opthea Appoints Parisa Zamiri, MD, PhD, as Chief Medical Officer

Australian drug developer Opthea announced Oct. 8 that it had appointed Parisa Zamiri, MD, PhD, as chief medical officer. Zamiri, an ophthalmologist, has clinical experience in medical retina, immu...

10/11/2024
BreakingIndustryRetina
Oak Hill Bio Promotes Josh Distler, JD, to Chief Executive Officer
Oak Hill Bio Promotes Josh Distler, JD, to Chief Executive Officer

Oak Hill Bio, of Cambridge, Massachusetts, announced Oct. 7 that it had promoted Josh Distler, JD, to chief executive officer. Distler is a co-founder of Oak Hill and previously served as the compa...

10/4/2024
BreakingRetinaSurgical
Harrow Relaunches Triesence Ophthalmic Corticosteroid in US
Harrow Relaunches Triesence Ophthalmic Corticosteroid in US

Nashville, Tennessee-based Harrow reported Oct. 3 that it had relaunchedTriesence (triamcinolone acetonide injectable suspension) 40 mg/mL, a preservative‑free synthetic corticosteroid, in the US. ...

10/4/2024
BreakingCataractFundingPharmaRegulation
Eyenovia Launches Clobetasol Drops for Postoperative Pain, Inflammation
Eyenovia Launches Clobetasol Drops for Postoperative Pain, Inflammation

Eyenovia announced Sept. 26 the US launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05%, known as Clobetasol, for postoperative inflammation and pain following oc...

10/4/2024
BreakingDealsDry EyeEuropeRegulation
EU Regulators Approve Vevizye from Novaliq; Théa Will Commercialize Dry Eye Drop
EU Regulators Approve Vevizye from Novaliq; Théa Will Commercialize Dry Eye Drop

Germany’s Novaliq announced Oct. 2 that the European Commission had approved its dry eye treatment Vevizye (cyclosporine ophthalmic solution) 0.1%. The product is indicated for the treatment of mod...

10/4/2024
BreakingIndustryInstrumentsSurgical
Zeiss Invests $24 Million to Expand Production Site in Chesterfield, Missouri
Zeiss Invests $24 Million to Expand Production Site in Chesterfield, Missouri

German company Carl Zeiss Meditec opened a new state-of-the-art research and production facility on Oct. 1 in Chesterfield, Missouri, expanding its footprint in the city, which is part of the St. L...

10/4/2024
BreakingDeviceRegulation
Ross Segan, MD, MBA, FACS, Takes Helm of FDA’s OPEQ
Ross Segan, MD, MBA, FACS, Takes Helm of FDA’s OPEQ

Ross Segan, MD, MBA, FACS, has becomedirector of the US FDA’s Office of Product Evaluation and Quality (OPEQ). The office, part of FDA’s Center for Devices and Radiological Health (CDRH), oversees ...

10/4/2024
BreakingCataractStudy
NEI Researchers Identify Protein That Clears Cataracts in Animals
NEI Researchers Identify Protein That Clears Cataracts in Animals

Researchers at the National Eye Institute (NEI), working with counterparts in China, have discovered a reversible cataract response in hibernating squirrels that may point toward a nonsurgical trea...

10/4/2024
BreakingCornealEurope
SIFI Launches Akantior Drops for Acanthamoeba Keratitis in Germany
SIFI Launches Akantior Drops for Acanthamoeba Keratitis in Germany

Italy’s SIFI announced Sept. 30 the launch in Germany of its Akantior (polihexanide 0.08%) drops for the treatment of Acanthamoeba keratitis (AK), a parasitic infection of the eye, in patients 12 a...

10/4/2024
BreakingCornealRegulation
Aurion Launches Vyznova Corneal Cell Therapy in Japan
Aurion Launches Vyznova Corneal Cell Therapy in Japan

Aurion Biotech announced Sept. 24 that it had launched Vyznova (neltependocel), a cell therapy for bullous keratopathy of the cornea, in Japan. Japanese regulators approved Vyznova in March 2023. T...

10/4/2024
BreakingDealsFundingRetina
Boehringer Ingelheim to Advance Surrozen’s Bi-specific Antibody in Retinal Disease
Boehringer Ingelheim to Advance Surrozen’s Bi-specific Antibody in Retinal Disease

Surrozen announced Sept. 24 that development partner Boehringer Ingelheim will advance SZN-413, a bi-specific antibody targeting retinal vascular disease. The milestone triggers a $10 million payme...

10/4/2024
BreakingIndustryRetina
Switzerland’s Rejuveron Life Sciences Rebrands as Centenara Labs
Switzerland’s Rejuveron Life Sciences Rebrands as Centenara Labs

Switzerland’s Rejuveron Life Sciences announced Sept. 19 that it had rebranded as Centenara Labs. The company develops and invests in therapeutic candidates to promote healthy aging. Centenara said...

10/4/2024
BreakingDealsRetina
Nanoscope Licenses Optogenetic Technology from Max Planck Innovation
Nanoscope Licenses Optogenetic Technology from Max Planck Innovation

Nanoscope Therapeutics announced Sept. 30 that it had acquired a license for CatCh optogenetic technology from Max Planck Innovation, the technology transfer arm of the Max Planck Society. Financia...

10/4/2024
BreakingRegulationRetina
US FDA Grants Fast Track Designation to Priovant’s Uveitis Candidate
US FDA Grants Fast Track Designation to Priovant’s Uveitis Candidate

Priovant Therapeutics, of Durham, North Carolina, reported Sept. 23 that the US FDA had granted fast track designation for brepocitinib in non-infectious intermediate or posterior uveitis or panuve...

10/4/2024
BreakingGene TherapyRegulationRetina
US FDA Grants Orphan Drug Status to Atsena’s XLRS Gene Therapy Candidate
US FDA Grants Orphan Drug Status to Atsena’s XLRS Gene Therapy Candidate

Atsena Therapeutics announced Sept. 17 that ATSN-201, its gene therapy candidate for X-linked retinoschisis (XLRS), had received the US FDA’s orphan drug designation. The candidate was granted rare...

10/4/2024
BreakingIndustryRetina
Eyconis Appoints Mark J. Bachleda, PharmD, MBA, as CEO
Eyconis Appoints Mark J. Bachleda, PharmD, MBA, as CEO

Eyconis announced Sept. 19 that it had appointed Mark J. Bachleda, PharmD, MBA, as chief executive officer and a member of its board of directors. Bachleda has served in executive leadership roles ...

10/4/2024
BreakingIndustryRetina
Luxa Biotechnology Appoints Keith Dionne, PhD, as CEO
Luxa Biotechnology Appoints Keith Dionne, PhD, as CEO

Luxa Biotechnology announced Oct. 1 that it had appointed Keith Dionne, PhD, as chief executive officer. Luxa, of Fort Lee, New Jersey, is advancing RPESC-RPE-4W, a cell product derived from adult ...

9/27/2024
BreakingCataractSurgical
Zeiss Announces Broad US Rollout of Micor 700 for Phaco-less Cataract Surgery
Zeiss Announces Broad US Rollout of Micor 700 for Phaco-less Cataract Surgery

Carl Zeiss Meditec reported Sept. 26 that it had begun broad US distribution of the Micor 700, the first hand-held device to extract a crystalline lens in cataract surgery without the need for ultr...

9/27/2024
BreakingEuropeGlaucomaPharmaRegulation
AbbVie Withdraws EU Marketing Application for Durysta
AbbVie Withdraws EU Marketing Application for Durysta

Europe’s Committee for Medicinal Products for Human Use (CHMP) announced Sept. 19 that AbbVie had withdrawn its marketing authorization application for the sustained-release glaucoma implant Duryst...

9/27/2024
BreakingDealsGlaucomaRetina
Nicox, Glaukos Sign Research and Option Agreement for Glaucoma Candidate
Nicox, Glaukos Sign Research and Option Agreement for Glaucoma Candidate

France’s Nicox announced Sept. 23 that it had signed an exclusive research and license option agreement with Glaukos for NCX 1728, Nicox’s novel nitric oxide (NO)-donating phosphodiesterase-5 (PDE5...

9/27/2024
BreakingPharmaRegulation
Tepezza Receives Approval in Japan to Treat Active Thyroid Eye Disease
Tepezza Receives Approval in Japan to Treat Active Thyroid Eye Disease

Amgen reported Sept. 24 that Tepezza had gained approval in Japan for the treatment of active or high clinical activity score thyroid eye disease (TED). The Thousand Oaks, California, company said ...

9/27/2024
BiosimilarsBreakingPharmaRetina
Amgen’s Pavblu is Fifth Aflibercept Biosimilar to Gain US Approval in 2024
Amgen’s Pavblu is Fifth Aflibercept Biosimilar to Gain US Approval in 2024

The FDA has approved Amgen’s Pavblu (aflibercept-ayyh), making it the fifth Eylea biosimilar to reach the milestone in the US in 2024. FDA records show Pavblu was approved Aug. 23. Labeling shows i...

9/27/2024
BiosimilarsBreakingEuropeRetina
Europe’s CHMP Recommends Two Aflibercept Biosimilars for Approval
Europe’s CHMP Recommends Two Aflibercept Biosimilars for Approval

Europe’s Committee for Medicinal Products for Human Use (CHMP) issued positive opinions on Sept. 19 for two new aflibercept (Eylea) biosimilars—Afqlir from Swiss drugmaker Sandoz and Opuviz, which ...

9/27/2024
BreakingDealsInstrumentsRetinaSurgical
Microsurgical Technology (MST) to Commercialize Vista Vitrectomy Products
Microsurgical Technology (MST) to Commercialize Vista Vitrectomy Products

Microsurgical Technology (MST) announced Sept. 17 that it had partnered with Vista Ophthalmics to commercialize Vista’s products—the Vista 1-Step vitrectomy probe and the Vista IS for maintaining t...

9/27/2024
BreakingGene TherapyIndustryRetina
AAVantgarde Bio Appoints Jayashree Sahni, MD, as Chief Medical Officer
AAVantgarde Bio Appoints Jayashree Sahni, MD, as Chief Medical Officer

Italy’s AAVantgarde Bio announced Sept. 9 that it had appointed Jayashree Sahni, MD, FRCOphth, EMBA, as chief medical officer. Sahni, a retina specialist, was senior global program clinical head at...

9/27/2024
BreakingIndustryPharma
Harrow to Add Nearly 150 Jobs as it Continues Expanding in Nashville
Harrow to Add Nearly 150 Jobs as it Continues Expanding in Nashville

Harrow reported Sept. 25 that it is creating nearly 150 new jobs as it expands its corporate headquarters in Nashville, Tennessee. The move follows the company increasing its total leased space in ...

9/20/2024
BreakingDealsPrivate Equity
Bausch + Lomb Explores Sale to Separate from Bausch Health
Bausch + Lomb Explores Sale to Separate from Bausch Health

Bausch + Lomb is working with Goldman Sachs to explore a sale of the company, the Financial Times reported Sept. 14, with private equity the most likely buyer. The move is being evaluated as a way ...

9/20/2024
BreakingEuropeRegulationRetina
Apellis Receives Negative CHMP Opinion on Pegcetacoplan in GA After Re-examination
Apellis Receives Negative CHMP Opinion on Pegcetacoplan in GA After Re-examination

Apellis Pharmaceuticals announced Sept. 20 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had reaffirmed its June 2024 negative opinion on the company’s ...

9/20/2024
BreakingStudySurgical
NYU Langone Hails Recovery of Man Over a Year after Landmark Whole Eye Transplant
NYU Langone Hails Recovery of Man Over a Year after Landmark Whole Eye Transplant

A surgical team at NYU Langone Health performed the world’s first whole eye and partial-face transplant in May 2023 for Aaron James, who had survived a high-voltage electrical accident at work. Ove...

9/20/2024
BreakingDealsDry Eye
NovaBay to Sell Avenova Products for $9.5 Million as Part of Dissolution Plan
NovaBay to Sell Avenova Products for $9.5 Million as Part of Dissolution Plan

NovaBay Pharmaceuticals has agreed to sell its Avenova products to PRNPhysician Recommended Nutriceuticals for $9.5 million in cash, the companies announced Sept. 20. The deal is expected to close ...

9/20/2024
BreakingDry EyeRegulation
US FDA Warns Regener-Eyes Maker Over Plant Conditions, Unapproved Products
US FDA Warns Regener-Eyes Maker Over Plant Conditions, Unapproved Products

The US FDA has sent a warning letter to Regenerative Processing Plant in Palm Harbor, Florida, finding fault with its manufacturing processes and raising concerns that its eye drop products may sti...

9/20/2024
AIBreakingDiagnosticIndiaRegulationRetina
Indian Regulators Approve First Ophthalmic AI Software—Medios DR from Remidio
Indian Regulators Approve First Ophthalmic AI Software—Medios DR from Remidio

India’s Remidio announced Sept. 13 that regulators there had approved its Medios DR software for autonomous detection of diabetic retinopathy (DR). Medios DR becomes the first ophthalmic artificial...

9/20/2024
AllergyBreakingChinaDealsRegulation
Nicox Reports that Ocumension Has Gained Approval for Zerviate in China
Nicox Reports that Ocumension Has Gained Approval for Zerviate in China

France’s Nicox announced Sept. 18 that partner Ocumension Therapeutics had received regulatory approval in China to commercialize Nicox’ Zerviate (cetirizine ophthalmic solution) 0.24% for ocular i...

9/20/2024
BreakingDealsGlaucomaPharma
Ripple, AbbVie to Collaborate on Fully Biodegradable Bimatoprost Implant for Glaucoma
Ripple, AbbVie to Collaborate on Fully Biodegradable Bimatoprost Implant for Glaucoma

Ripple Therapeutics, of Toronto, Canada, announced Sept. 17 that it had signed a collaboration agreement with AbbVie to develop RTC-620, a fully biodegradable sustained-release intracameral bimatop...

9/13/2024
BreakingDiagnosticNewsletterRefractive
Zeiss Plans to Use Creal's Technology to Reimagine Refractive Exams
Zeiss Plans to Use Creal's Technology to Reimagine Refractive Exams

Zeiss will integrate Swiss company Creal’s light field display technology into its refractive diagnostic equipment under a collaboration agreement, the two companies reported Sept. 10. Creal descri...

9/13/2024
BreakingDiagnosticGlaucomaPerimetry
Oculus Debuts Frequency Doubling Perimetry with Easyfield VR
Oculus Debuts Frequency Doubling Perimetry with Easyfield VR

Oculus has announced the addition of frequency doubling perimetry (FDP) to its Easyfield VR visual field diagnostic headset, along with standard automated perimetry. The German ophthalmic diagnosti...

9/13/2024
BreakingClinical TrialRetinaStudySurgical
OcuDyne Reports Positive Pilot Study Results Using Ophthalmic Artery Angioplasty in GA
OcuDyne Reports Positive Pilot Study Results Using Ophthalmic Artery Angioplasty in GA

OcuDyne, of Brooklyn Park, Minnesota, reported Sept. 9 that it had successfully completed a pilot study using its Optic System to perform ophthalmic artery angioplasty in patients with geographic a...

9/13/2024
BreakingClinical TrialPharmaRegulationRetina
US FDA Gives Go-Ahead to Trial of BlueRock’s Cell Therapy Candidate for Photoreceptor Diseases
US FDA Gives Go-Ahead to Trial of BlueRock’s Cell Therapy Candidate for Photoreceptor Diseases

Bayer subsidiary BlueRock Therapeutics announced Sept. 3 that the US FDA had cleared its investigational new drug application for a Phase I/IIa trial of OpCT-001, an induced pluripotent stem cell (...

9/13/2024
BreakingGlaucomaIndustryMIGSSurgical
iStar Medical Appoints Richard Beckman, MD, as Chief Medical Officer
iStar Medical Appoints Richard Beckman, MD, as Chief Medical Officer

Belgium’s iStar Medical announced Sept. 4 that it had appointed Richard Beckman, MD, as chief medical officer and member of the company’s board. Beckman most recently served as CMO of Adverum Biote...

9/13/2024
BreakingGene TherapyRegulationRetina
US FDA Grants Orphan Drug Status to Skyline’s Gene Therapy Candidate for RP
US FDA Grants Orphan Drug Status to Skyline’s Gene Therapy Candidate for RP

China’s Skyline Therapeutics announced Sept. 3 that the US FDA had granted orphan drug designation to SKG1108, an intravitreal gene therapy candidate for retinitis pigmentosa (RP). SKG1108 is a rec...

9/13/2024
BreakingIndustryPharmaRetina
Belite Bio Appoints Hendrik P.N. Scholl, MD, MA, as Chief Medical Officer
Belite Bio Appoints Hendrik P.N. Scholl, MD, MA, as Chief Medical Officer

Belite Bio announced Sept. 1 that it had appointed Hendrik P.N. Scholl, MD, MA, as chief medical officer, effective immediately. Scholl specializes in inherited retinal and macular dystrophies, and...

9/13/2024
BreakingIndustryPharmaRetina
BioCryst Appoints Donald Fong, MD, as Chief Medical Officer
BioCryst Appoints Donald Fong, MD, as Chief Medical Officer

BioCryst Pharmaceuticals, of Durham, North Carolina, announced Sept. 5 that it had appointed Donald S. Fong, MD, MPH, as the company’s new chief medical officer, effective immediately. Fong joined ...

9/6/2024
BreakingEuropeRefractiveSurgical
Carl Zeiss Meditec Introduces Hyperopia Treatment Using Lenticule Extraction
Carl Zeiss Meditec Introduces Hyperopia Treatment Using Lenticule Extraction

German company Carl Zeiss Meditec reported Aug. 24 that it had become the first medical device manufacturer to introduce in the CE market the treatment of hyperopia using lenticule extraction. This...

9/6/2024
BreakingClinical TrialDiagnosticGlaucoma
Injectsense Completes First Human Implantation of its Ultraminiaturized IOP Sensor
Injectsense Completes First Human Implantation of its Ultraminiaturized IOP Sensor

Injectsense, of Emeryville, California, announced Aug. 27 that it had implanted its first ultraminiature wireless sensor for measuring intraocular pressure (IOP). Glaucoma specialist Juan Mura, MD,...

9/6/2024
BreakingRetinaStudy
Light Control May Prevent Eye Damage in Premature Infants, Study Shows
Light Control May Prevent Eye Damage in Premature Infants, Study Shows

A study in mice at the Science of Light Center at Cincinnati Children’s shows that lighting conditions can change how newborn eyes develop, with darkness fostering the development of more rods, the...

9/6/2024
BreakingEmergingGene TherapyRetina
Tern Therapeutics Launches with $15 Million Financing and Pipeline in CLN2 Batten Disease 
Tern Therapeutics Launches with $15 Million Financing and Pipeline in CLN2 Batten Disease

Tern Therapeutics announced its launch Aug. 27, along with closing of a $15 million financing. The company also reported that it had licensed gene therapy candidates RGX-381 and RGX-181 (now design...

9/6/2024
AmblyopiaBreakingChinaRegulation
NovaSight Gains Approval in China for CureSight System for Amblyopia
NovaSight Gains Approval in China for CureSight System for Amblyopia

Israel-based NovaSight reported Sept. 4 that its CureSight eye-tracking system for amblyopia in children had gained approval from Chinese regulators, expanding the device’s availability to the thre...

9/6/2024
BreakingDiagnosticFundusRetina
Visionix Unveils its VX 610 Automated Fundus Camera
Visionix Unveils its VX 610 Automated Fundus Camera

Visionix USA has announced the launch of its VX 610 non-mydriatic automated fundus camera. The VX 610 boasts a range of automated features, including auto alignment, auto focus, and auto capture, w...

9/6/2024
BreakingCataractClinical TrialPharmaRegulation
Oculis Shuts Down Phase III Trial of OCS-01 Due to Third-Party Administrative Error
Oculis Shuts Down Phase III Trial of OCS-01 Due to Third-Party Administrative Error

Swiss company Oculis reported Aug. 27 in its Q2-2024 financial statement that it was shutting down the Phase III OPTIMIZE-2 trial of its OCS-01 eye drop candidate for postsurgical inflammation and ...

9/6/2024
BreakingClinical TrialGene TherapyRegulationRetina
Health Canada Gives Green Light to Phase III Trial of Ocugen’s Gene Therapy Candidate for RP
Health Canada Gives Green Light to Phase III Trial of Ocugen’s Gene Therapy Candidate for RP

Ocugen announced Aug. 26 that Health Canada had cleared the way for a Canadian Phase III trial of OCU400, a modifier gene therapy candidate for retinitis pigmentosa (RP). Ocugen, of Malvern, Pennsy...

8/30/2024
BreakingCataractESCRSEuropeIOLSurgical
Rayner to Roll Out First Spiral IOL at 2024 ESCRS Congress
Rayner to Roll Out First Spiral IOL at 2024 ESCRS Congress

UK-based Rayner reported Aug. 26 that it was set to launch the first spiral intraocular lens models—the RayOne Galaxy and Galaxy Toric—at the 2024 ESCRS Congress, set for Sept. 6-10 in Barcelona, S...

8/30/2024
BreakingCataractIOLRevenueSingle-UseSurgical
Alcon Reports Q2-2024 Net Sales of $2.5 Billion
Alcon Reports Q2-2024 Net Sales of $2.5 Billion

Alcon reported Aug. 20 that its Q2-2024 net sales totaled $2.5 billion, a record quarter for the company and a 3 percent increase (+6 percent cc) over $2.4 billion in Q2-2023. Surgical net sales fo...

8/30/2024
BreakingCornealEuropePharmaRegulation
European Commission Approves SIFI’s Akantior Drops for Acanthamoeba Keratitis
European Commission Approves SIFI’s Akantior Drops for Acanthamoeba Keratitis

Italy’s SIFI announced Aug. 26 that the European Commission had approved Akantior (polihexanide 0.08%) drops for the treatment of Acanthamoeba keratitis (AK), a parasitic infection of the eye, in p...

8/30/2024
BreakingCataractRegulationSurgical
Precision Lens and Estate of Paul Ehlen to Pay US $12M over Kickbacks
Precision Lens and Estate of Paul Ehlen to Pay US $12M over Kickbacks

Minnesota-based ophthalmic distributor Precision Lens and the estate of co-founder Paul Ehlen have agreed to pay the US government $12 million to resolve a case involving kickback payments in vario...

8/30/2024
BreakingPharmaRegulationRetina
Six States Sue Regeneron over Eylea Drug Price Reporting
Six States Sue Regeneron over Eylea Drug Price Reporting

The attorneys general for Colorado, Georgia, Michigan, North Carolina, Texas, and Washington have filed suit in federal district court against Regeneron Pharmaceuticals, claiming the drugmaker infl...

8/30/2024
AIBreakingDealsDiagnosticEuropeGlaucomaRetina
Revenio’s iCare Subsidiary Acquires AI Screening Company Thirona Retina
Revenio’s iCare Subsidiary Acquires AI Screening Company Thirona Retina

Finland’s Revenio Group announced Aug. 20 that its iCare subsidiary had assumed ownership of the Dutch artificial intelligence (AI) software company Thirona Retina. iCare had made a minority invest...

8/30/2024
BreakingCataractClinical TrialPharmaStudy
Livionex’ Cataract Drop Candidate to Advance After New Analysis of Study Results
Livionex’ Cataract Drop Candidate to Advance After New Analysis of Study Results

A new analysis of 2008 clinical study data has given a boost to Livionex’ topical drop candidate for cataracts, the John Moran Eye Center reported Aug. 16. The drop, called C-KAD, is a formulation ...

8/30/2024
AIBreakingRetina
SriniVas Sadda, MD, Named Doheny Endowed Chair, Capping Year of New Roles
SriniVas Sadda, MD, Named Doheny Endowed Chair, Capping Year of New Roles

The Doheny Eye Institute announced Aug. 14 that SriniVas Sadda, MD, had been named the A. Ray Irvine Jr., MD, Endowed Chair. He also was recently named president of the Association for Research in ...

8/23/2024
BreakingDealsGlaucomaPharma
Visiox to Merge with Ocuvex to Advance Candidates for Glaucoma, Postsurgical Pain and Inflammation
Visiox to Merge with Ocuvex to Advance Candidates for Glaucoma, Postsurgical Pain and Inflammation

Visiox Pharmaceuticals announced Aug. 19 that it had agreed to merge with Ocuvex Therapeutics, a privately held company in New Hyde Park, New York. A Visiox news release said Ocuvex has a pipeline ...

8/23/2024
BreakingEuropeRegulationRetina
EMA Accepts Marketing Application for Aflibercept (Eylea) Biosimilar from Alvotech
EMA Accepts Marketing Application for Aflibercept (Eylea) Biosimilar from Alvotech

Biosimilar company Alvotech and its partner Advanz Pharma announced Aug. 15 that the European Medicines Agency (EMA) had accepted a marketing authorization application for AVT06, Alvotech’s propose...

8/23/2024
BreakingClinical TrialIndustry
Acelyrin Shifts Pipeline to Focus on TED Candidate, Lays Off About 40 Workers
Acelyrin Shifts Pipeline to Focus on TED Candidate, Lays Off About 40 Workers

Acelyrin reported Aug. 13 that it would reduce its workforce and shift its pipeline strategy to prioritize lonigutamab, its candidate for thyroid eye disease (TED). The announcement came amid posit...

8/23/2024
BreakingGenericsIndiaRegulation
US FDA Grants Tentative Approval to Generic Brimonidine Tartrate Ophthalmic Solution (Lumify) from Lupin
US FDA Grants Tentative Approval to Generic Brimonidine Tartrate Ophthalmic Solution (Lumify) from Lupin

Indian drugmaker Lupin announced Aug. 14 that it had received tentative approval from the US FDA for its abbreviated new drug application for brimonidine tartrate ophthalmic solution 0.025%, a gene...

8/23/2024
BreakingGene TherapyRegulationRetina
US FDA Grants Rare Pediatric Disease Designation to Atsena’s X-Linked Retinoschisis Gene Therapy Candidate
US FDA Grants Rare Pediatric Disease Designation to Atsena’s X-Linked Retinoschisis Gene Therapy Candidate

Atsena Therapeutics announced Aug. 14 that ATSN-201, its gene therapy candidate for X-linked retinoschisis (XLRS), had received the US FDA’s rare pediatric disease designation. XLRS is a monogenic ...

8/23/2024
BreakingGene TherapyRegulationRetina
US FDA Grants Rare Pediatric Disease Designation to Opus’ LCA5 Gene Therapy Candidate
US FDA Grants Rare Pediatric Disease Designation to Opus’ LCA5 Gene Therapy Candidate

Opus Genetics announced Aug. 20 that OPGx-LCA5, its gene therapy candidate for Leber congenital amaurosis (LCA) resulting from biallelic mutations in the LCA5 gene, had received the US FDA’s rare p...

8/23/2024
BreakingDry EyePharmaRegulation
Eyenovia Plans to Seek US FDA Clearance for Gen-2 Optejet Microdoser
Eyenovia Plans to Seek US FDA Clearance for Gen-2 Optejet Microdoser

Eyenovia announced in its Q2-2024 financial results that it planned to seek marketing clearance for an advanced Gen-2 Optejet microdoser. Eyenovia, of New York, said production was expected to begi...

8/23/2024
BreakingGene TherapyIndustryRetina
SalioGen Therapeutics Appoints Kali Stasi, MD, PhD, as Chief Medical Officer
SalioGen Therapeutics Appoints Kali Stasi, MD, PhD, as Chief Medical Officer

SalioGen Therapeutics announced Aug. 19 that it had appointed Kalliopi “Kali” Stasi, MD, PhD, as chief medical officer. SalioGen said Stasi will be responsible for bringing the company’s SGT-1001, ...

8/16/2024
BreakingChinaDealsDry EyePharma
Ocumension Acquires Rights to Alcon Eye Drops in Exchange for 16.7 Percent Equity Stake
Ocumension Acquires Rights to Alcon Eye Drops in Exchange for 16.7 Percent Equity Stake

China’s Ocumension Therapeutics announced Aug. 13 that it would acquire or secure Chinese rights to a portfolio of Alcon dry eye treatments and procedural drops. In exchange, Ocumension will issue ...

8/16/2024
BiosimilarsBreakingCataractDiagnosticDry EyeGlaucomaLaserOcular CancerRefractiveRetinaRevenueSurgical
Q2-2024 Ophthalmic Revenue Roundup for AbbVie, Carl Zeiss Meditec, Amgen, STAAR, Astellas, Immunocore, Tarsus, Biogen, Lensar, and Iridex
Q2-2024 Ophthalmic Revenue Roundup for AbbVie, Carl Zeiss Meditec,  Amgen, STAAR, Astellas, Immunocore, Tarsus, Biogen, Lensar, and Iridex

AbbVie, of North Chicago, Illinois, reported July 25 that Q2-2024 net revenue for its eye care products totaled $533 million, a 13.3 percent decline (-10.9 percent cc) from $617 million in Q2-2023....

8/16/2024
BiosimilarsBreakingRegulationRetina
US FDA Approves Aflibercept (Eylea) Biosimilar from Sandoz
US FDA Approves Aflibercept (Eylea) Biosimilar from Sandoz

Swiss drugmaker Sandoz announced Aug. 12 that the US FDA had approved Enzeevu, an aflibercept (Eylea) biosimilar, for wet age-related macular degeneration (AMD). Enzeevu (aflibercept-abzv) will be ...

8/16/2024
BreakingPresbyopiaRegulation
Lenz Submits NDA to US FDA for LNZ100 Presbyopia Drop Candidate
Lenz Submits NDA to US FDA for LNZ100 Presbyopia Drop Candidate

Lenz Therapeutics announced Aug. 12 that it had submitted a new drug application to the US FDA for LNZ100, a once-daily, preservative-free eye drop candidate for presbyopia. Lenz, of San Diego, Cal...

8/16/2024
BreakingGenericsIndiaRegulation
US FDA Approves Generic Prednisolone Acetate Drops from India’s Lupin for Ocular Inflammation
US FDA Approves Generic Prednisolone Acetate Drops from India’s Lupin for Ocular Inflammation

Indian drugmaker Lupin announced Aug. 5 that the US FDA had approved its abbreviated new drug application for prednisolone acetate ophthalmic suspension, 1%, a generic equivalent of AbbVie’s Pred F...

8/16/2024
BreakingDeviceRegulationRetina
LumiThera Gains CPT Code to Report Retinal PBM Therapy, a Step Toward Reimbursement
LumiThera Gains CPT Code to Report Retinal PBM Therapy, a Step Toward Reimbursement

LumiThera announced Aug. 7 that a new Category III CPT code had been established, effective Jan. 1, 2025, to report “Photobiomodulation therapy of retina, single session.” The company said the code...

8/16/2024
BreakingCornealDealsPharma
Santen Licenses Cloudbreak Topical Pterygium Candidate for Japan, Korea, and Southeast Asia
Santen Licenses Cloudbreak Topical Pterygium Candidate for Japan, Korea, and Southeast Asia

Japan’s Santen announced Aug. 6 that it had signed an agreement to license CBT-001, a topical pterygiumtreatment candidate from Cloudbreak Pharma. The deal covers the territories of Japan, South Ko...

8/16/2024
BreakingFundingGene TherapyRegulationRetina
US FDA Approves Expanded Access Program for Ocugen’s RP Candidate
US FDA Approves Expanded Access Program for Ocugen’s RP Candidate

Ocugen announced Aug. 5 that the US FDA had approved an expanded access program to allow for the treatment of adults with retinitis pigmentosa (RP) with OCU400—a modifier gene therapy product candi...

8/8/2024
BreakingCataractDealsSurgical
Lensar Ends Collaboration with Oertli for Phaco Portion of Ally Cataract System
Lensar Ends Collaboration with Oertli for Phaco Portion of Ally Cataract System

Lensar has terminated its collaboration agreement with Swiss company Oertli, according to a filing Aug. 5 with the US Securities and Exchange Commission. The two had been developing the Ally Adapti...

8/9/2024
BreakingCataractDry EyeGlaucomaIOLRetinaRevenueSurgical
Q2-2024 Ophthalmic Revenue Roundup for Hoya, Harrow, RxSight, Sight Sciences, Ocular Therapeutix, and EyePoint
Q2-2024 Ophthalmic Revenue Roundup for Hoya, Harrow, RxSight, Sight Sciences, Ocular Therapeutix, and EyePoint

Japan-based Hoya Corporation announced Aug. 1 that its medical care segment (IOLs, endoscopes, artificial bone) had revenue for the quarter ending June 30, 2024—the first quarter of its fiscal year...

8/9/2024
BreakingDry EyeGlaucoma
USC Alums Gift Eye Care Practice to Roski Eye Institute
USC Alums Gift Eye Care Practice to Roski Eye Institute

Richard Weise, MD, and his wife, Cathy, have gifted their ophthalmic practice, the Glendale Eye Medical Group, of Glendale, California, to the USC Roski Eye Institute, the university announced July...

8/9/2024
BreakingRegulation
Physician With Blepharospasm Fights MACs’ Proposed Limits on Botulinum Toxin Injections
Physician With Blepharospasm Fights MACs’ Proposed Limits on Botulinum Toxin Injections

Patients with blepharospasm, a rare ophthalmic disease, are facing a proposal by five of the seven Medicare administrative contractors to limit the botulinum toxin injections that control their sym...

8/9/2024
BreakingCornealRetina
Mallinckrodt Announces Availability of Acthar Gel SelfJect Injector in the US
Mallinckrodt Announces Availability of Acthar Gel SelfJect Injector in the US

Ireland-based Mallinckrodt announced Aug. 6 that its H.P. Acthar Gel single-dose prefilled SelfJect injector was available in the US. The US FDA approved the supplemental new drug application (sNDA...

8/9/2024
BreakingRegulationStudy
NEI Would Fold Into Another NIH Institute Under Lawmaker’s Proposed Restructuring
NEI Would Fold Into Another NIH Institute Under Lawmaker’s Proposed Restructuring

The status of the National Eye Institute (NEI) as a separate unit within the National Institutes of Health (NIH) would come to an end under a proposal by a US House committee chair to consolidate t...

8/9/2024
BreakingCataractDealsDry EyePharmaSurgical
Formosa Licenses Clobetasol Propionate Drops to Apotex for Canada
Formosa Licenses Clobetasol Propionate Drops to Apotex for Canada

Taiwan-based Formosa Pharmaceuticals announced Aug. 5 that it had agreed to license to Apotex exclusive rights to market clobetasol propionate 0.05% eye drops for postsurgical inflammation and pain...

8/9/2024
AIBreakingLow Vision
Eyedaptic Unveils Eye6 with Ivy AI-Assisted Visual Aid
Eyedaptic Unveils Eye6 with Ivy AI-Assisted Visual Aid

Eyedaptic, of Laguna Hills, California, reported Aug. 5 that it had unveiled its Eye6 with Ivy next-generation wearable vision aid for those with age-related macular degeneration or other retinal d...

8/9/2024
BreakingCataractCornealSurgical
HCP Cureblindness Rebrands as Cure Blindness Project
HCP Cureblindness Rebrands as Cure Blindness Project

HCP Cureblindness has rebranded as the Cure Blindness Project, the group announced July 29. The move is designed to better reflect the eye charity’s expanded geographical footprint and commitment t...

8/2/2024
BreakingEuropeGlaucomaLaserRegulationSurgical
ViaLase Gains CE Marking for Femtosecond Laser for Glaucoma Treatment
ViaLase Gains CE Marking for Femtosecond Laser for Glaucoma Treatment

ViaLase announced July 30 that the European Union had granted CE marking for its ViaLase Laser for the treatment of adults with primary open-angle glaucoma. The system uses an OCT-guided femtosecon...

8/2/2024
BreakingCornealDiagnosticDry EyeGlaucomaIOLLaserRetinaRevenueSurgical
Q2-2024 Ophthalmic Revenue Roundup for Regeneron, Roche, Bausch + Lomb, Novartis, and Four Others
Q2-2024 Ophthalmic Revenue Roundup for Regeneron, Roche, Bausch + Lomb, Novartis, and Four Others

Regeneron, of Tarrytown, New York, reported Aug. 1 that its Q2-2024 US revenue for Eylea was $1.53 billion, a 2 percent increase from $1.5 billion in Q2-2023. Eylea HD accounted for $304 million of...

8/2/2024
BreakingEuropeRegulationRetina
Roche’s Vabysmo Gains EU Approval for Third Indication—RVO
Roche’s Vabysmo Gains EU Approval for Third Indication—RVO

Swiss drugmaker Roche announced July 30 that the European Commission had approved Vabysmo for a third indication, the treatment of macular edema due to retinal vein occlusion (RVO). Vabysmo (farici...

8/2/2024
BiosimilarsBreakingDry EyeEuropeRegulationRetina
Novaliq Receives Positive CHMP Opinion for Vevizye in Dry Eye
Novaliq Receives Positive CHMP Opinion for Vevizye in Dry Eye

Germany’s Novaliq announced July 29 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended marketing authorization in the European Union for Vevi...

8/2/2024
BreakingDealsDry Eye
Eyenovia, SGN Nanopharma Will Collaborate on Chronic Dry Eye Candidate with Optejet Microdoser
Eyenovia, SGN Nanopharma Will Collaborate on Chronic Dry Eye Candidate with Optejet Microdoser

Eyenovia, of New York, announced July 30 that it had entered into a collaboration agreement with SGN Nanopharma to develop SGN’s micellar nanoparticle platform-based cyclosporine formulation for us...

8/2/2024
BreakingRefractiveStudySurgical
OHSU Researchers Discover Link Between Proteins in Tears, Pain After Eye Surgery
OHSU Researchers Discover Link Between Proteins in Tears, Pain After Eye Surgery

Researchers at Oregon Health & Science University (OHSU) say they have discovered a connection between postsurgical ocular pain and levels of certain proteins found in patients’ tears. Some patient...

8/2/2024
BreakingOcular CancerRegulation
US FDA Grants Rare Pediatric Drug Status to Theriva’s Retinoblastoma Candidate
US FDA Grants Rare Pediatric Drug Status to Theriva’s Retinoblastoma Candidate

Theriva Biologics, of Rockville, Maryland, announced July 31 that the US FDA had granted rare pediatric drug designation for VCN-01, its treatment candidate for retinoblastoma. The FDA had already ...

8/2/2024
BreakingGene TherapyRegulationRetina
Adverum Receives US FDA’s RMAT Designation for Ixo-vec in Wet AMD
Adverum Receives US FDA’s RMAT Designation for Ixo-vec in Wet AMD

Adverum Biotechnologies announced Aug. 1 that Ixo-vec, its intravitreal gene therapy candidate for wet age-related macular degeneration (AMD), had received the US FDA’s regenerative medicine advanc...

7/26/2024
BreakingCornealDealsDiagnosticDry EyeSurgical
Bausch + Lomb Acquires Dry Eye Diagnostic Company Trukera Medical
Bausch + Lomb Acquires Dry Eye Diagnostic Company Trukera Medical

Bausch + Lomb announced July 23 that it had acquired dry eye diagnostic company Trukera Medical from its private equity owner, AccelMed Partners, and other shareholders. No financial details were d...

7/26/2024
BreakingCornealDealsDry EyeIndustry
Eyenovia, Senju Will Collaborate on Chronic Dry Eye Candidate with Optejet Microdoser
Eyenovia, Senju Will Collaborate on Chronic Dry Eye Candidate with Optejet Microdoser

Eyenovia, of New York, announced July 23 that it had entered into a collaboration agreement with Japan’s Senju Pharmaceutical to develop Senju’s corneal epithelial wound healing candidate, SJP-0035...

7/26/2024
BreakingChinaLow VisionRetinaSurgical
Samsara Says First SING IMT for AMD Has Been Implanted in China
Samsara Says First SING IMT for AMD Has Been Implanted in China

Samsara Vision, of Far Hills, New Jersey, announced July 22 that the first SING IMT procedure for age-related macular degeneration (AMD) had been completed in China. The SING IMT, which stands for ...

7/26/2024
AllergyBreakingDry Eye
New OTC Eye Lubricants Available from AbbVie, Ocusoft
New OTC Eye Lubricants Available from AbbVie, Ocusoft

AbbVie has introduced two new preservative-free lubricant eye drop products—Refresh Tears PF and Refresh Relieva PF Xtra. AbbVie, of North Chicago, Illinois, said the new products feature a soft-sq...

7/26/2024
BreakingGlaucomaIndustrySurgical
Cancer Company TME Pharma Plans to Spin Off NOX-E36 for Eye Disease
Cancer Company TME Pharma Plans to Spin Off NOX-E36 for Eye Disease

Germany’s TME Pharma, a clinical-stage cancer company, announced July 22 that it planned to spin off its asset NOX-E36 to advance it for eye disease. NOX-E36 is an L-stereoisomer RNA aptamer inhibi...

7/26/2024
BreakingCornealEuropeRegulation
Advisory Panel Recommends Orphan Drug Status for SIFI’s Polihexanide in Fungal Keratitis
Advisory Panel Recommends Orphan Drug Status for SIFI’s Polihexanide in Fungal Keratitis

Italy’s SIFI announced July 22 that a European advisory panel had recommended orphan drug designation for its polihexanide eye drop for fungal keratitis. The Committee for Orphan Medicinal Products...

7/26/2024
BreakingGene TherapyIndustryRetina
Beacon Appoints Lance Baldo, MD, as Chief Executive Officer
Beacon Appoints Lance Baldo, MD, as Chief Executive Officer

Beacon Therapeutics announced July 24 that it had named Lance Baldo, MD, as chief executive officer, effective Aug. 12, 2024. Most recently, Baldo served as chief medical officer at Freenome, an ea...

7/19/2024
BreakingDealsDiagnosticOCT
EssilorLuxottica Acquires Majority Stake in Diagnostics Maker Heidelberg 
EssilorLuxottica Acquires Majority Stake in Diagnostics Maker Heidelberg

Eyewear conglomerate EssilorLuxottica announced July 17 that it had agreed to acquire an 80 percent stake in Heidelberg Engineering, a leader in ophthalmic diagnostic imaging. Financial details wer...

7/19/2024
BreakingCorneal
Claes H. Dohlman, MD, PhD, Corneal Research Pioneer and Inventor of the Boston KPro, Dies at 101
Claes H. Dohlman, MD, PhD, Corneal Research Pioneer and Inventor of the Boston KPro, Dies at 101

Claes H. Dohlman, MD, PhD, considered by many to be the father of modern corneal science, died July 14, Massachusetts Eye and Ear announced in a press release. He was 101. Dohlman, who was born in ...

7/19/2024
BreakingCataractRegulation
Medicare Advantage Insurers Make Millions Off Ophthalmic Diagnoses They Add to Patient Records, WSJ Reports
Medicare Advantage Insurers Make Millions Off Ophthalmic Diagnoses They Add to Patient Records, WSJ Reports

Private insurers involved in the US Medicare Advantage program added hundreds of thousands of questionable diagnoses, including those for diabetic cataracts, to patient records in recent years to b...

7/19/2024
BreakingCataractIOLRevenueSurgical
J&J Vision Generates Q2-2024 Surgical Revenue of $367 Million
J&J Vision Generates Q2-2024 Surgical Revenue of $367 Million

J&J Vision’s Q2-2024 global surgical revenue totaled $367 million, a 0.5 percent decrease (1.2 percent increase in constant currency) from $369 million in Q2-2023, parent Johnson & Johnson, of New ...

7/19/2024
BreakingDealsGene TherapyRetina
Beacon Will Evaluate Abeona’s AAV204 Capsid for Select Ophthalmic Indications
Beacon Will Evaluate Abeona’s AAV204 Capsid for Select Ophthalmic Indications

Beacon Therapeutics will evaluate Abeona Therapeutics’ patented AAV204 capsid for potential gene therapies for select ophthalmic indications, the companies announced July 11. AAV204, a novel AAV ca...

7/19/2024
BreakingEmergingRegulationRetina
NexThera Files IND with US FDA for Trial of Wet AMD Eye Drop Candidate
NexThera Files IND with US FDA for Trial of Wet AMD Eye Drop Candidate

NexThera, of Busan, South Korea, announced July 16 that it had filed an investigational new drug (IND) application with the US FDA for a Phase I/IIa trial of NT-101, an eye drop candidate for wet a...

7/19/2024
BreakingRefractiveSurgical
Ophthalmic Chain in Colorado Closing All Six Clinics, Citing COVID-19 Financial Fallout
Ophthalmic Chain in Colorado Closing All Six Clinics, Citing COVID-19 Financial Fallout

Rocky Mountain Eye Center, based in Pueblo, Colorado, announced on its website that it will close all of its six clinics on July 31, saying the practice was unable to recover from the financial fal...

7/19/2024
BreakingClinical TrialCornealDry Eye
Okyo Pharma to Initiate Phase II Trial for OK-101 in Neuropathic Corneal Pain
Okyo Pharma to Initiate Phase II Trial for OK-101 in Neuropathic Corneal Pain

London’s Okyo Pharma announced July 11 that it would advance OK-101 into a Phase II clinical trial of neuropathic corneal pain (NCP). The US FDA cleared the investigational new drug (IND) applicati...

7/19/2024
AIBreakingDiagnosticDigitalIndustry
Eyenuk Appoints Bryan Haardt as Chief Executive Officer
Eyenuk Appoints Bryan Haardt as Chief Executive Officer

Digital health care company Eyenuk, of Los Angeles, California, announced July 18 that it had appointed Bryan Haardt as chief executive officer. Paul Praino, who had been serving as Eyenuk’s interi...

7/19/2024
BreakingIndustryMyopia
Sydnexis Appoints Perry J. Sternberg as Chief Executive Officer
Sydnexis Appoints Perry J. Sternberg as Chief Executive Officer

Sydnexis, of Del Mar, California, announced July 16 that Perry J. Sternberg had been appointed chief executive officer and as a member of the board of directors. He will join the company on Aug. 5,...

7/11/2024
BreakingEuropeRegulationRetina
UK Regulators Approve Outlook’s Lytenava (Bevacizumab) for Wet AMD
UK Regulators Approve Outlook’s Lytenava (Bevacizumab) for Wet AMD

Outlook Therapeutics announced July 8 that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) had granted marketing authorization for Lytenava, an ophthalmic formulation of bevaciz...

7/11/2024
BreakingDeviceRegulation
Ophthalmic Devices to be Included in FDA TAP Program
Ophthalmic Devices to be Included in FDA TAP Program

The US FDA announced July 1 that it was expanding its TAP pilot program in October to include ophthalmic devices, as well as radiological health devices. The voluntary program, officially named the...

7/11/2024
BreakingRegulationRetina
US FDA Approves Vabysmo Prefilled Syringe for Wet AMD, DME, RVO
US FDA Approves Vabysmo Prefilled Syringe for Wet AMD, DME, RVO

Genentech, a member of the Roche Group, announced July 5 that the US FDA had approved the Vabysmo (faricimab-svoa) 6.0 mg single-dose prefilled syringe for wet age-related macular degeneration (AMD...

7/11/2024
BreakingRetina
Genentech to Reintroduce Susvimo for Wet AMD, Ending Voluntary Recall
Genentech to Reintroduce Susvimo for Wet AMD, Ending Voluntary Recall

Genentech, a member of the Roche Group, announced July 8 that it was reintroducing Susvimo, a refillable ranibizumab intravitreal implant for wet age-related macular degeneration (AMD) in the US, e...

7/11/2024
BreakingCataractDealsEuropeRefractiveSurgical
Ophthalmology Chain Clínica Baviera Enters UK Market with Acquisition of Optimax
Ophthalmology Chain Clínica Baviera Enters UK Market with Acquisition of Optimax

European ophthalmology chain Clínica Baviera has extended its reach into the UK with the purchase of Optimax. Optimax (Eye Hospitals Group and subsidiaries) operates 19 clinics under the Optimax an...

7/11/2024
BiosimilarsBreakingEuropeRegulationRetina
Altos Biologics Files for European Approval of Aflibercept (Eylea) Biosimilar
Altos Biologics Files for European Approval of Aflibercept (Eylea) Biosimilar

Altos Biologics has submitted a marketing authorization application to the European Medicines Agency (EMA) for ALT-L9, an aflibercept (Eylea) biosimilar, according to a joint announcement by Altos ...

7/11/2024
BreakingChinaEmergingRetina
China’s DP Technology Will Advance Oral Lp-PLA2 Inhibitor for DR and DME
China’s DP Technology Will Advance Oral Lp-PLA2 Inhibitor for DR and DME

China’s DP Technology announced July 8 that it would advance DPT0415, a novel small molecule targeting lipoprotein‐associated phospholipase A2 (Lp-PLA2), as a potential oral treatment candidate for...

7/11/2024
BreakingIndustryRetina
Alkeus Appoints Michel Dahan as President and CEO
Alkeus Appoints Michel Dahan as President and CEO

Alkeus Pharmaceuticals announced July 2 that Michel Dahan had joined the company as president and chief executive officer. He had served as a member of the board since January 2023. Alkeus, of Camb...

7/5/2024
BreakingDeviceGlaucomaRegulation
IOP-Lowering Goggles Developed by John Berdahl, MD, Gain De Novo Nod for Marketing
IOP-Lowering Goggles Developed by John Berdahl, MD, Gain De Novo Nod for Marketing

Balance Ophthalmics has gained US FDA de novo classification for its FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) system, a goggles and pump system designed to lower intraocular pressure (IOP) i...

7/5/2024
BiosimilarsBreakingRegulationRetina
US FDA Approves Aflibercept (Eylea) Biosimilar from Formycon, Klinge
US FDA Approves Aflibercept (Eylea) Biosimilar from Formycon, Klinge

German companies Formycon and Klinge Biopharma announced June 28 that the US FDA had approved their aflibercept (Eylea) biosimilar for wet age-related macular degeneration (AMD), diabetic macular e...

7/5/2024
BreakingCornealDealsFundingRefractive
J&J Leads Series A Round for Crosslinking Tech Developer TecLens
J&J Leads Series A Round for Crosslinking Tech Developer TecLens

Johnson & Johnson is the lead investor in a Series A funding round for Stamford, Connecticut-based TecLens, developer of a new crosslinking technology, J&J announced June 21. The technology is inte...

7/5/2024
BreakingEuropeRegulationRetina
Roche’s Vabysmo Gains Positive CHMP Opinion in EU for Third Indication—RVO
Roche’s Vabysmo Gains Positive CHMP Opinion in EU for Third Indication—RVO

Swiss drugmaker Roche announced June 28 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended the extension of Vabysmo’s labeling to include tre...

7/5/2024
BreakingStudy
Blinking Boosts Visual Perception Rather than Hindering It, Study Shows
Blinking Boosts Visual Perception Rather than Hindering It, Study Shows

Researchers at the University of Rochester have found that blinking plays a critical role in visual perception, in addition to maintaining eye health. Their research was published in April 2024 in ...

7/5/2024
BreakingCornealRegulation
US FDA Grants Breakthrough, Regenerative Medicine Status to Aurion’s Corneal Cell Therapy Candidate
US FDA Grants Breakthrough, Regenerative Medicine Status to Aurion’s Corneal Cell Therapy Candidate

Aurion Biotech announced June 19 that the US FDA had granted both breakthrough therapy and regenerative medicine advanced therapy status for AURN001, the company’s allogeneic cell therapy candidate...

7/5/2024
BreakingDealsDry Eye
Kane Biotech Licenses Biofilm Dispersion Enzyme to I-Med for Dry Eye
Kane Biotech Licenses Biofilm Dispersion Enzyme to I-Med for Dry Eye

Kane Biotech announced June 25 that I-Med Pharma had licensed its DispersinB biofilm dispersion technology to incorporate into its products to relieve dry eye. It’s the first commercial agreement f...

7/5/2024
BreakingDealsIndiaPharmaRetina
RevOpsis Enlists India’s Kemwell Biopharma to Manufacture Wet AMD Candidate
RevOpsis Enlists India’s Kemwell Biopharma to Manufacture Wet AMD Candidate

RevOpsis Therapeutics, of San Carlos, California, announced June 17 that it had entered into a strategic manufacturing partnership with India’s Kemwell Biopharma. The deal aims to accelerate develo...

6/28/2024
BreakingCataractRegulationRetinaSurgical
Alcon Gains US FDA 510(k) Clearance for Unity VCS and CS Systems
Alcon Gains US FDA 510(k) Clearance for Unity VCS and CS Systems

Alcon reported June 24 that itsUnity Vitreoretinal Cataract System (VCS) and Unity Cataract System (CS) had received US FDA 510(k) clearance. The company said it would be seeking real-world feedbac...

6/28/2024
AcquisitionsBreakingDealsPharma
ANI Pharmaceuticals to Acquire Alimera Sciences, Maker of Iluvien and Yutiq, for $381 Million
ANI Pharmaceuticals to Acquire Alimera Sciences, Maker of Iluvien and Yutiq, for $381 Million

ANI Pharmaceuticals announced June 24 that it would acquire Alimera Sciences, maker of Iluvien and Yutiq, in a deal worth $381 million up front. The deal is expected to close in late Q3-2024, the c...

6/28/2024
BreakingPharmaRegulationRetinaSurgical
Harrow Looks to Relaunch Triesence in 2024, as Production Testing Continues
Harrow Looks to Relaunch Triesence in 2024, as Production Testing Continues

Nashville, Tennessee-based Harrow reported June 20 that it was moving closer to relaunching Triesence in 2024 after successfully achieving a production testing milestone. Triesence (triamcinolone a...

6/28/2024
BreakingRegulationRetina
US FDA Accepts BLA for Neurotech’s MacTel Candidate, Grants Priority Review
US FDA Accepts BLA for Neurotech’s MacTel Candidate, Grants Priority Review

Neurotech Pharmaceuticals announced June 20 that the US FDA had accepted its biologic license application (BLA) and granted priority review for NT-501, an encapsulated cell therapy implant candidat...

6/28/2024
BreakingMyopiaRegulation
Vyluma Plans to Resubmit NDA for Low-Dose Atropine for Myopia after Meeting with US FDA
Vyluma Plans to Resubmit NDA for Low-Dose Atropine for Myopia after Meeting with US FDA

Vyluma announced June 18 that it had met with the US FDA’s Division of Ophthalmology to discuss resubmitting its new drug application (NDA) for lead compound NVK002, a low-dose formulation of atrop...

6/28/2024
BreakingClinical TrialGene TherapyRegulationRetina
US FDA Gives Green Light to Trial of 4DMT’s Gene Therapy Candidate for GA
US FDA Gives Green Light to Trial of 4DMT’s Gene Therapy Candidate for GA

4D Molecular Therapeutics announced June 24 that the US FDA had cleared its investigational new drug application for a Phase I clinical trial of 4D-175, an intravitreal gene therapy candidate targe...

6/28/2024
BreakingData SecurityRegulation
CMS Winding Down Funding Program to Address Change Healthcare Cyberattack
CMS Winding Down Funding Program to Address Change Healthcare Cyberattack

The Centers for Medicare and Medicaid Services announced June 17 that funding it made available to health care providers under the Change Healthcare/Optum Payment Disruption (CHOPD) program would e...

6/28/2024
BreakingDiagnosticRefractiveRegulationTelehealth
Evolution Optiks Receives US FDA 510(k) Clearance for Tele-refactor
Evolution Optiks Receives US FDA 510(k) Clearance for Tele-refactor

Barbados-based Evolution Optiks announced June 4 that it had received 510(k) clearance from the US FDA for the LFR-260, its light field powered subjective tele-refractor. The device gained CE marki...

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