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.

Regulation News

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
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...

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
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
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
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...

11/15/2024
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
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...

11/14/2024
NewsletterRegulationRetina
US FDA Asks for Added Data on Neurotech MacTel Candidate, Delays PDUFA Date
US FDA Asks for Added Data on Neurotech MacTel Candidate, Delays 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...

11/14/2024
DeviceNewsletterRegulationRetina
US FDA Grants De Novo Classification to LumiThera’s System for Dry AMD
US FDA Grants De Novo Classification to LumiThera’s System for Dry AMD

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

11/14/2024
DiagnosticIOLNewsletterOCTRegulation
Select US FDA Approvals and Clearances in October 2024
Select US FDA Approvals and Clearances in October 2024

The US FDA granted four clearances through the ophthalmic device division using the 510(k) pathway in October 2024, according to the agency’s database. Apple gained clearance for its Digital Prism ...

11/14/2024
NewsletterPharmaPresbyopiaRegulation
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...

11/14/2024
AAOMeetingNewsletterPharmaRegulation
AAO Puts FDA Deputy Director of Ophthalmology on the Hot Seat
AAO Puts FDA Deputy Director of Ophthalmology on the Hot Seat

William Boyd, MD, deputy director of ophthalmology at the US FDA’s Office of New Drugs, had a quick answer when asked to name the biggest unmet need in ophthalmology. “We need and want more therapi...

11/14/2024
AIDiagnosticEmergingGlaucomaNewsletterOcular CancerRegulationRetinaTelehealth
Emerging Companies Pursuing Ophthalmic Indications, November 2024
Emerging Companies Pursuing Ophthalmic Indications, November 2024

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

11/14/2024
CataractClinical TrialDealsDiagnosticDry EyeFundingGene TherapyGlaucomaIndustryInstrumentsMicroscopesNewsletterOCTPresbyopiaRegulationRetinaStudySurgical
November 2024 Ophthalmic News Briefs
November 2024 Ophthalmic News Briefs

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...

11/14/2024
DeviceNewsletterRegulation
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...

11/8/2024
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
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...

11/1/2024
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
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...

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...

10/18/2024
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
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
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...

10/15/2024
EuropeGlaucomaNewsletterPharmaRegulation
AbbVie Withdraws EU Marketing Application for Durysta Implant for Glaucoma
AbbVie Withdraws EU Marketing Application for Durysta Implant for Glaucoma

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...

10/15/2024
CornealDiagnosticGlaucomaLaserNewsletterRegulation
Select US FDA Approvals and Clearances in September 2024
Select US FDA Approvals and Clearances in September 2024

The US FDA granted two clearances through the ophthalmic device division using the 510(k) pathway in September 2024, according to the agency’s database. Zeiss gained clearance for its combination Y...

10/15/2024
ESCRSEuropeMeetingNewsletterRegulation
ESCRS iNovation Day Looks at MDR Roadblocks, Global Care Issues
ESCRS iNovation Day Looks at MDR Roadblocks, Global Care Issues

The impact of Europe’s new Medical Device Regulation (MDR) on innovation sparked considerable discussion during the ESCRS iNovation Day. The meeting was held Sept. 6 in Barcelona, Spain, ahead of t...

10/15/2024
BiosimilarsEuropeNewsletterRegulationRetina
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 ...

10/15/2024
NewsletterRefractiveRegulationSurgical
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...

10/15/2024
ChinaClinical TrialDealsDiagnosticDry EyeEuropeGene TherapyGlaucomaIndiaIndustryLaserNewsletterPerimetryRegulationRetinaSurgical
October 2024 Ophthalmic News Briefs
October 2024 Ophthalmic News Briefs

Oculus has announced the addition of frequency doubling perimetry (FDP) to its Easyfield VR visual field diagnostic headset. The German ophthalmic diagnostic company, with US headquarters in Arling...

10/15/2024
DeviceNewsletterRegulation
FDA Names New Leaders at OPEQ and CDHR
FDA Names New Leaders at OPEQ and CDHR

Ross Segan, MD, MBA, FACS, has become director 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...

10/11/2024
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...

10/4/2024
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
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
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
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...

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
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 ...

9/20/2024
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
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...

9/19/2024
EuropeNewsletterRegulation
EC Approves SIFI’s Akantior Drops for Acanthamoeba Keratitis
EC 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...

9/19/2024
DiagnosticNewsletterRegulation
Select US FDA Approvals and Clearances in August 2024
Select US FDA Approvals and Clearances in August 2024

The US FDA granted four clearances through the ophthalmic device division using the 510(k) pathway in August 2024, according to the agency’s database. Notably, newcomer Intelon Optics received clea...

9/19/2024
CataractClinical TrialNewsletterPharmaRegulation
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 ...

9/19/2024
CataractNewsletterRegulationSurgical
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...

9/19/2024
NewsletterPharmaRegulationRetina
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...

9/19/2024
AmblyopiaClinical TrialDiagnosticFundusGene TherapyGlaucomaIndustryNewsletterRegulationRetinaSurgical
September 2024 Ophthalmic News Briefs
September 2024 Ophthalmic News Briefs

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 ...

9/13/2024
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
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...

9/6/2024
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
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
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...

8/23/2024
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...

8/21/2024
EuropeNewsletterRegulationRevenue
European Five Market Expected to Grow, Despite MDR Delays
European Five Market Expected to Grow, Despite MDR Delays

Device makers’ added costs for compliance with the new Medical Device Regulation (MDR) in the European Union (EU) will likely affect the mix of ophthalmic products and companies in the region. Howe...

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...

8/21/2024
NewsletterRegulationStudy
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...

8/21/2024
CataractIOLNewsletterRegulationRetina
Select US FDA Approvals and Clearances in July 2024
Select US FDA Approvals and Clearances in July 2024

The US FDA granted two clearances through the ophthalmic device division using the 510(k) pathway in July 2024, according to the agency’s database. Topcon gained clearance for its Maestro2 OCT in c...

8/21/2024
EuropeGlaucomaLaserNewsletterRegulationSurgical
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...

8/21/2024
NewsletterRegulation
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 (MACs) to limit the botulinum toxin injections that control th...

8/21/2024
BiosimilarsCornealDealsDry EyeEuropeGene TherapyGenericsIndustryLow VisionNewsletterOcular CancerPharmaPresbyopiaRegulationRetina
August 2024 Ophthalmic News Briefs
August 2024 Ophthalmic News Briefs

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 for t...

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
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...

8/9/2024
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
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...

8/2/2024
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
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
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
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...

7/23/2024
DeviceGlaucomaNewsletterRegulation
IOP-Lowering Goggles Developed by John Berdahl, MD, Gain De Novo Certification for Marketing
IOP-Lowering Goggles Developed by John Berdahl, MD, Gain  De Novo Certification 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...

7/23/2024
CataractGlaucomaNewsletterRegulation
Select US FDA Approvals and Clearances in June 2024
Select US FDA Approvals and Clearances in June 2024

The US FDA granted four clearances through the ophthalmic device division using the 510(k) pathway in June 2024, according to the agency’s database. Alcon gained clearance for its much-anticipated ...

7/23/2024
DeviceNewsletterRegulation
Ophthalmic Devices to be Included in FDA TAP Accelerator Program
Ophthalmic Devices to be Included in FDA TAP Accelerator 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...

7/23/2024
CataractNewsletterRegulation
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...

7/23/2024
EuropeNewsletterRegulationRetina
US FDA Approves Vabysmo Prefilled Syringe for Wet AMD, DME, and RVO Indications
US FDA Approves Vabysmo Prefilled Syringe for Wet AMD, DME, and RVO Indications

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...

7/23/2024
BiosimilarsClinical TrialCornealDealsDry EyeEuropeGene TherapyGlaucomaIndiaIndustryMyopiaNewsletterRegulationRetina
July 2024 Ophthalmic News Briefs
July 2024 Ophthalmic News Briefs

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...

7/19/2024
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
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...

7/11/2024
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
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 ...

7/5/2024
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
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
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...

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
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...

6/24/2024
ChinaIOLNewsletterRegulation
Volume-Based Procurement Could Upend China’s IOL Market
Volume-Based Procurement Could Upend China’s IOL Market

Alcon offered big discounts in China’s public sector centralized volume-based procurement (VBP) cycle for intraocular lenses (IOLs). The company’s low bids in seven of the eight bidding categories ...

6/24/2024
EuropeNewsletterRegulationRetina
EU Regulators Approve Outlook’s Lytenava (Bevacizumab) for Wet AMD
EU Regulators Approve Outlook’s Lytenava (Bevacizumab) for Wet AMD

Outlook Therapeutics announced May 28 that the European Commission had granted marketing authorization for Lytenava, an ophthalmic formulation of bevacizumab for the treatment of wet age-related ma...

6/24/2024
CornealEuropeNewsletterRegulation
SIFI’s Acanthamoeba Keratitis Eye Drop Candidate Gains Positive CHMP Opinion
SIFI’s Acanthamoeba Keratitis Eye Drop Candidate Gains Positive CHMP Opinion

Italy’s SIFI announced May 31 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended approval of Akantior (polihexanide 0.08%) for the treatment...

6/24/2024
DiagnosticFundusGlaucomaIOLNewsletterOCTRegulationSurgical
Select US FDA Approvals and Clearances in May 2024
Select US FDA Approvals and Clearances in May 2024

The US FDA granted six clearances through the ophthalmic device division using the 510(k) pathway in May 2024, according to the agency’s database. Reichert gained market clearance for its new hand-...

6/24/2024
NewsletterRegulationRetinaStudy
Apellis Reports Syfovre Preserved Visual Function at 36 Months in Extension Study
Apellis Reports Syfovre Preserved Visual Function at 36 Months in Extension Study

Apellis Pharmaceuticals reported June 10 that Syfovre (pegcetacoplan injection), its treatment for geographic atrophy (GA), preserved visual function at 36 months in the GALE long-term extension st...

6/24/2024
IOLNewsletterRegulation
Bausch + Lomb Receives Health Canada Approval for EnVista Envy Trifocal IOL
Bausch + Lomb Receives Health Canada Approval  for EnVista Envy Trifocal IOL

Bausch + Lomb announced May 28 that Health Canada had approved the enVista Envy trifocal intraocular lens (IOL). It’s the first approval for the new lens. The Envy was expected to be available in C...

6/24/2024
CataractGlaucomaNewsletterRegulationSurgical
Surgeons, Societies Respond to MACs’ New Proposed MIGS Limits
Surgeons, Societies Respond to MACs’ New Proposed MIGS Limits

Surgeons and ophthalmic societies worked together at open meetings in June to address five Medicare administrative contractors’ latest proposal to limit coverage of minimally invasive glaucoma surg...

6/24/2024
CataractClinical TrialData SecurityDealsDiagnosticDry EyeGene TherapyGlaucomaIOLIndustryMyopiaNewsletterRefractiveRegulationRetinaSurgical
June 2024 Ophthalmic News Briefs
June 2024 Ophthalmic News Briefs

Japan’s Nidek announced June 3 that it had launched the RS-1 Glauvas OCT system. The device is CE marked as a Class IIa device. Nidek said the RS-1 Glauvas’ streamlined workflow and advanced analyt...

6/14/2024
BreakingCataractRegulationSurgical
WPS MAC Revisits Changing Coverage for Cataract Surgery
WPS MAC Revisits Changing Coverage for Cataract Surgery

WPS Insurance Corporation, a Medicare administrative contractor (MAC) in the US, has again proposed changing its coverage of cataract surgery after putting forth a similar proposal in September 202...

6/14/2024
BreakingData SecurityRegulation
ARPA-H Launches UPGRADE to Strengthen Hospitals’ Cybersecurity
ARPA-H Launches UPGRADE to Strengthen Hospitals’ Cybersecurity

ARPA-H announced May 30 a program called UPGRADE, designed to eliminate cyberattacks on hospitals by developing tools that proactively probe digital hospital environments for software weaknesses. A...

6/14/2024
BreakingCataractEuropeIOLRegulationSurgical
Nidek Gains CE Marking for Preloaded IOL Injector System
Nidek Gains CE Marking for Preloaded IOL Injector System

Japan’s Nidek announced June 10 that it had received CE marking for the NP-1/NP-1C preloaded IOL injection system. The system is preloaded with the Aktis aspheric hydrophobic soft acrylic lens, whi...

6/14/2024
BreakingPharmaRegulationRetina
Belite Bio Receives Sakigake (Pioneer Drug) Nod in Japan for Tinlarebant in Stargardt
Belite Bio Receives Sakigake (Pioneer Drug) Nod in Japan for Tinlarebant in Stargardt

Belite Bio announced June 12 that Japanese regulators had granted the Sakigake, or pioneer therapy, designation to its lead candidate, tinlarebant, an oral tablet targeting Stargardt disease. Belit...

6/7/2024
BreakingGlaucomaRegulationSurgical
MACs Propose New Limits on MIGS Procedures
MACs Propose New Limits on MIGS Procedures

Five Medicare administrative contractors have proposed new limits to their coverage of minimally invasive glaucoma surgery (MIGS). The move comes a year after the same MACs roiled the glaucoma subs...

6/7/2024
BreakingClinical TrialGene TherapyRegulationRetina
US FDA Gives Green Light to Trial of Avirmax’ Gene Therapy Candidate for Wet AMD with PCV
US FDA Gives Green Light to Trial of Avirmax’ Gene Therapy Candidate for Wet AMD with PCV

Avirmax Biopharma announced May 30 that the US FDA had cleared its investigational new drug application for a Phase I/IIa clinical trial of its intravitreal gene therapy candidate targeting wet age...

6/7/2024
BreakingCornealEuropeRegulation
Acanthamoeba Keratitis Eye Drop Candidate from SIFI Gains Positive CHMP Opinion
Acanthamoeba Keratitis Eye Drop Candidate from SIFI Gains Positive CHMP Opinion

Italy’s SIFI announced May 31 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended approval of Akantior (polihexanide 0.08%) for the treatment...

5/31/2024
BreakingEuropePharmaRegulationRetina
EU Regulators Approve Outlook’s Lytenava (Bevacizumab) for Wet AMD
EU Regulators Approve Outlook’s Lytenava (Bevacizumab) for Wet AMD

Outlook Therapeutics announced May 28 that the European Commission had granted marketing authorization for Lytenava, an ophthalmic formulation of bevacizumab for the treatment of wet age-related ma...

5/31/2024
BreakingCataractIOLRegulationSurgical
Bausch + Lomb Receives Health Canada Approval for EnVista Envy Trifocal IOL
Bausch + Lomb Receives Health Canada Approval for EnVista Envy Trifocal IOL

Bausch + Lomb announced May 28 that Health Canada had approved the enVista Envy trifocal intraocular lens (IOL). It’s the first approval for the new lens. The Envy is expected to be available in Ca...

5/31/2024
BreakingDry EyeRegulation
Santen Recalls All Unexpired Lots of Diquas LX Over Issues with Preservative
Santen Recalls All Unexpired Lots of Diquas LX Over Issues with Preservative

Santen has issued a voluntary recall and suspended shipment for all unexpired lots of its dry eye treatment Diquas LX in Japan due to issues with a preservative, Pharma Japan reported May 23. Sante...

5/31/2024
BreakingEuropeMyopiaRegulation
EU Accepts Vyluma’s Marketing Application for Low-Dose Atropine in Childhood Myopia
EU Accepts Vyluma’s Marketing Application for Low-Dose Atropine in Childhood Myopia

Vyluma reported May 29 that the European Medicines Agency had accepted its marketing application for lead compound NVK002, a low-dose formulation of atropine targeting childhood myopia. NVK002 is a...

5/24/2024
BiosimilarsBreakingRegulationRetina
US FDA Approves First Interchangeable Biosimilars to Eylea
US FDA Approves First Interchangeable Biosimilars to Eylea

The FDA announced May 20 that it had approved the US’ first interchangeable biosimilars to Eylea (aflibercept)— Yesafili, from India’s Biocon Biologics, and Opuviz, which was jointly developed by B...

5/24/2024
BreakingGlaucomaRegulationSurgical
New World Medical Gains US 510(k) Clearance for KDB Glide
New World Medical Gains US 510(k) Clearance for KDB Glide

New World Medical reported May 22 that its Kahook Dual Blade Glide (KDB Glide) had gained US FDA 510(k) clearance. The KDB Glide was previously classified as a Class 1, 510(k)-exempt device. With t...

5/24/2024
BreakingClinical TrialRegulationRetina
US FDA Gives Green Light to Phase Ib Trial of Drug Farm’s Oral ALPK1 Inhibitor in ROSAH Patients
US FDA Gives Green Light to Phase Ib Trial of Drug Farm’s Oral ALPK1 Inhibitor in ROSAH Patients

Drug Farm, of Shanghai, China, announced May 17 that the US FDA had cleared its investigational new drug (IND) application for a Phase Ib trial of its DF-003, an oral alpha kinase 1 (ALPK1) inhibit...

5/24/2024
BreakingChinaRegulation
Chinese Regulators Accept NDA from Innovent for IBI311 in Thyroid Eye Disease
Chinese Regulators Accept NDA from Innovent for IBI311 in Thyroid Eye Disease

China’s Innovent Biologics announced May 20 that Chinese regulators had accepted the new drug application for IBI311, a recombinant anti-insulin-like growth factor 1 receptor antibody for thyroid e...

5/22/2024
DiagnosticNewsletterRegulationRetina
US FDA Grants De Novo Authorization to Notal Vision’s Scanly AI-Powered Home OCT
US FDA Grants De Novo Authorization to Notal Vision’s Scanly AI-Powered Home OCT

Notal Vision announced May 16 that the US FDA had granted de novo marketing authorization for its patient-operated Scanly home optical coherence tomography (OCT) device. The Scanly uses artificial ...

5/22/2024
DiagnosticNewsletterRegulation
Select US FDA Approvals and Clearances in April 2023
Select US FDA Approvals and Clearances in April 2023

The US FDA granted two clearances through the ophthalmic device division using the 510(k) pathway in April 2024, according to the agency’s database. Topcon received 510(k) clearance for its Maestro...

5/22/2024
NewsletterRegulationRetina
US FDA Approves First Interchangeable Biosimilars to Eylea
US FDA Approves First Interchangeable Biosimilars to Eylea

The FDA announced May 20 that it had approved the US’ first interchangeable biosimilars to Eylea (aflibercept)— Yesafili, from India’s Biocon Biologics, and Opuviz, which was jointly developed by B...

5/22/2024
CataractChinaCornealDiagnosticDry EyeGlaucomaIndiaMicroscopesNewsletterPharmaRegulationRetina
May 2024 Ophthalmic News Briefs
May 2024 Ophthalmic News Briefs

Taiwan-based Formosa Pharmaceuticals announced May 9 that it had entered into an exclusive licensing agreement with Tabuk Pharmaceuticals to market clobetasol propionate 0.05% eye drops for post-su...

5/17/2024
BreakingDiagnosticOCTRegulation
US FDA Grants De Novo Marketing Authorization to Notal Vision’s Scanly AI-Powered Home OCT
US FDA Grants De Novo Marketing Authorization to Notal Vision’s Scanly AI-Powered Home OCT

Notal Vision announced May 16 that the US FDA had granted de novo marketing authorization for its patient-operated Scanly home optical coherence tomography (OCT) device. The Scanly uses artificial ...

5/17/2024
BreakingPharmaRegulationRetina
Outlook Submits UK Marketing Application for Ophthalmic Bevacizumab in Wet AMD
Outlook Submits UK Marketing Application for Ophthalmic Bevacizumab in Wet AMD

Outlook Therapeutics announced May 13 that it had submitted a marketing authorization application to the UK’s Medicines and Healthcare Products Regulatory Agency for ONS-5010 (bevacizumab gamma) fo...

5/3/2024
AIBreakingDiagnosticFundusRegulationRetina
US FDA Approves Aeye’s Autonomous AI DR Screening with Hand-held Fundus Camera
US FDA Approves Aeye’s Autonomous AI DR Screening with Hand-held Fundus Camera

Aeye Health announced April 30 that the US FDA had approved the company’s autonomous artificial intelligence-aided screening technology for diabetic retinopathy (DR) using a hand-held retinal camer...

5/3/2024
BreakingPharmaRegulation
US FDA Approves Preservative-Free Lumify Drops from Bausch + Lomb
US FDA Approves Preservative-Free Lumify Drops from Bausch + Lomb

Bausch + Lomb announced April 26 that the US FDA had approved a preservative-free formulation of Lumify redness reliever eye drops. Lumify is an over-the-counter formulation of low-dose brimonidine...

5/3/2024
BreakingClinical TrialRegulationRetina
US FDA Accepts IND for Eluminex’ Tri-specific Antibody Candidate for DME
US FDA Accepts IND for Eluminex’ Tri-specific Antibody Candidate for DME

China-headquartered Eluminex Biosciences announced April 30 that the US FDA had accepted its investigational new drug (IND) application for EB-105, a tri-specific fusion antibody candidate for diab...

4/26/2024
BiosimilarsBreakingRegulationRetina
US FDA Rejects Xbrane’s Ranibizumab Biosimilar, Citing Analysis and Manufacturing Issues
US FDA Rejects Xbrane’s Ranibizumab Biosimilar, Citing Analysis and Manufacturing Issues

Sweden’s Xbrane Biopharma announced April 21 that the US FDA had issued a complete response letter rejecting Xbrane’s ranibizumab biosimilar, branded in Europe as Ximluci. The company said regulato...

4/24/2024
DigitalIOLNewsletterRegulation
Select US FDA Approvals and Clearances in March 2024
Select US FDA Approvals and Clearances in March 2024

The US FDA granted three clearances through the ophthalmic device division using the 510(k) pathway in March 2024, according to the agency’s database. Cylite received clearance for its HP-OCT. The ...

4/24/2024
EuropeNewsletterRegulationRetina
Ophthalmic Bevacizumab Candidate from Outlook Gains Positive CHMP Opinion
Ophthalmic Bevacizumab Candidate from Outlook Gains Positive CHMP Opinion

Outlook Therapeutics announced March 22 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion recommending approval of ONS-5010 (L...

4/24/2024
BiosimilarsNewsletterRegulationRetina
US FDA Backs Call to Eliminate Interchangeability Designation for Biosimilars
US FDA Backs Call to Eliminate Interchangeability Designation for Biosimilars

A US FDA official has expressed support for measures before Congress to remove the interchangeability designation for biosimilars, claiming that the two-tier system is only causing confusion. It ca...

4/24/2024
ASCRSDry EyeEyeceleratorNewsletterPharmaRegulation
Eyecelerator Celebrates Fourth Anniversary While Showcasing Innovation in Ophthalmology
Eyecelerator Celebrates Fourth Anniversary While Showcasing Innovation in Ophthalmology

A nor’easter storm that disrupted many travel itineraries failed to deter the nearly 600 industry personnel and clinicians who attended Eyecelerator ahead of the 2024 ASCRS meeting. This year’s con...

4/24/2024
NewsletterPharmaRegulationSurgical
Chambers Retires from US FDA After 36-Plus Years of Ophthalmic Drug Review
Chambers Retires from US FDA  After 36-Plus Years of Ophthalmic  Drug Review

Wiley Chambers, MD, an ophthalmologist who conducted or supervised the review of ophthalmic drugs at the US FDA for 36½ years, retired from the agency Jan. 13, 2024. The 65-year-old is now serving ...

4/24/2024
CataractIOLNewsletterRegulationSurgical
BVI Medical Launches Podeye Hydrophobic Monofocal IOL in Japan
BVI Medical Launches Podeye Hydrophobic Monofocal IOL in Japan

BVI Medical announced April 17 that it had launched its Podeye hydrophobic monofocal IOL in Japan, following approval by the Japanese Pharmaceuticals and Medical Devices Agency. The lens was set to...

4/24/2024
GenericsGlaucomaNewsletterPharmaRegulation
Generic Drugmakers Sued by Large Employers in Price Fixing Scheme
Generic Drugmakers Sued by Large Employers in Price Fixing Scheme

Nine large employers—including American Airlines, Aramark, General Motors, Target, and Lowe’s—have filed a new lawsuit against leading makers of generic drugs, claiming the drugmakers have engaged ...

4/24/2024
NewsletterPharmaRegulationRetina
US Accuses Regeneron of Fraudulent Drug Price Reporting for Eylea
US Accuses Regeneron of Fraudulent Drug Price Reporting for Eylea

The US Justice Department has accused New York-based Regeneron of fraudulently manipulating Medicare’s drug pricing process for Eylea, costing the Medicare system hundreds of millions of dollars. T...

4/24/2024
Clinical TrialCornealData SecurityDealsDiagnosticDry EyeEnvironmentFundingGlaucomaIOLIndustryMicroscopesNewsletterRegulationRetina
April 2024 Ophthalmic News Briefs
April 2024 Ophthalmic News Briefs

Alexion, the rare disease unit of AstraZeneca, announced March 25 that the US FDA had approved its long-acting C5 complement inhibitor Ultomiris (ravulizumab-cwvz) for adults with neuromyelitis opt...

4/19/2024
BiosimilarsBreakingRegulation
US FDA Backs Call to Eliminate Interchangeability Designation for Biosimilars
US FDA Backs Call to Eliminate Interchangeability Designation for Biosimilars

A US FDA official has expressed support for measures before Congress to remove the interchangeability designation for biosimilars, claiming that the two-tier system is only causing confusion. Under...

4/12/2024
BreakingGenericsGlaucomaPharmaRegulation
Leading Generic Drugmakers Sued by Large Employers in Price Fixing Scheme
Leading Generic Drugmakers Sued by Large Employers in Price Fixing Scheme

Nine large employers—including American Airlines, Aramark, General Motors, Target, and Lowe’s—have filed a new lawsuit against leading makers of generic drugs, claiming the drugmakers have engaged ...

4/12/2024
BreakingPharmaRegulationRetina
US Accuses Regeneron of Fraudulent Drug Price Reporting for Eylea
US Accuses Regeneron of Fraudulent Drug Price Reporting for Eylea

The US Justice Department has accused New York-based Regeneron of fraudulently manipulating Medicare’s drug pricing process for Eylea, costing the Medicare system hundreds of millions of dollars. T...

4/12/2024
BreakingClinical TrialGene TherapyRegulationRetina
US FDA Clears IND Amendment with New Mobility Test for Phase III Trial of Ocugen RP Gene Therapy Candidate
US FDA Clears IND Amendment with New Mobility Test for Phase III Trial of Ocugen RP Gene Therapy Candidate

Ocugen announced April 8 that the US FDA had cleared the company’s investigational new drug (IND) amendment to initiate a Phase III clinical trial of OCU400, a modifier gene therapy candidate for r...

4/5/2024
BreakingRegulation
Viatris, Ocuphire Announce US Launch of Ryzumvi Eye Drops to Reverse Pupil Dilation
Viatris, Ocuphire Announce US Launch of Ryzumvi Eye Drops to Reverse Pupil Dilation

Viatris and Ocuphire Pharma announced April 1 the US launch of Ryzumvi (phentolamine ophthalmic solution) 0.75% for the reversal of pharmacologically induced mydriasis. The US FDA approved Ryzumvi ...

4/5/2024
BreakingGlaucomaRegulation
Glaukos’ iDose Gets J-Code for Medical Billing in the US
Glaukos’ iDose Gets J-Code for Medical Billing in the US

The Centers for Medicare and Medicaid Services (CMS) has issued a J-code for Glaukos’ iDose. The billing code takes effect July 1, 2024. iDose TR gained US FDA approval under the 505(b)(2) pathway ...

3/29/2024
BreakingClinical TrialGene TherapyRegulationRetina
Nanoscope Reports Positive Results for RP Optogenetic Therapy, Plans to file BLA in H2-2024
Nanoscope Reports Positive Results for RP Optogenetic Therapy, Plans to file BLA in H2-2024

Nanoscope Therapeutics on March 26 reported positive topline results from its two-year Phase IIb clinical trial of MCO-010, an ambient-light-activatable optogenetic monotherapy to restore vision in...

3/29/2024
BreakingData SecurityRegulation
State Department Offers up to $10 Million for Info on Hackers of Change Healthcare
State Department Offers up to $10 Million for Info on Hackers of Change Healthcare

The US State Department announced March 27 that it was offering a reward of up to $10 million for information on ALPHV BlackCat-linked hackers targeting critical infrastructure in the US. The agenc...

3/29/2024
BreakingPharmaRegulationSurgical
Chambers Retires from US FDA After 36-Plus Years of Ophthalmic Drug Review
Chambers Retires from US FDA After 36-Plus Years of Ophthalmic Drug Review

Wiley Chambers, MD, an ophthalmologist who conducted or supervised the review of ophthalmic drugs at the US FDA for 36 1/2 years, retired from the agency Jan. 13, 2024. The 65-year-old is now servi...

3/29/2024
BreakingClinical TrialRegulationRetina
Belite Bio Applies to Japanese Regulators for Clinical Trial of Oral Stargardt Candidate
Belite Bio Applies to Japanese Regulators for Clinical Trial of Oral Stargardt Candidate

Belite Bio announced March 22 that it had applied to Japan’s Pharmaceuticals and Medical Devices Agency for clearance to conduct a clinical trial of tinlarebant, its oral treatment candidate for St...

3/29/2024
BreakingRegulationRetina
US FDA Approves Alexion’s C5 Inhibitor Ultomiris for Adults with NMOSD
US FDA Approves Alexion’s C5 Inhibitor Ultomiris for Adults with NMOSD

Alexion, the rare disease unit of AstraZeneca, announced March 25 that the US FDA had approved its long-acting C5 complement inhibitor Ultomiris (ravulizumab-cwvz) for the treatment of adults with ...

3/22/2024
BreakingEuropeRegulationRetina
Ophthalmic Bevacizumab Candidate from Outlook Gains Positive CHMP Opinion
Ophthalmic Bevacizumab Candidate from Outlook Gains Positive CHMP Opinion

Outlook Therapeutics announced March 22 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion recommending approval of ONS-5010 (L...

3/22/2024
BreakingRegulationRetina
Eylea HD, Izervay Get Billing J-Codes in the US
Eylea HD, Izervay Get Billing J-Codes in the US

The Centers for Medicare and Medicaid Services (CMS) has issued J-codes for Regeneron’s Eylea HD and Astellas Pharma’s Izervay. The billing codes take effect April 1, 2024. Eylea HD (aflibercept) i...

3/22/2024
BreakingClinical TrialCornealRegulation
US FDA Gives Green Light to Phase I Trial of Fuchs’ Candidate from Design Therapeutics
US FDA Gives Green Light to Phase I Trial of Fuchs’ Candidate from Design Therapeutics

Design Therapeutics reported March 19 in its 2023 financial statement that the US FDA had cleared its investigational new drug (IND) application for a clinical trial of DT-168 in Fuchs’ endothelial...

3/21/2024
CataractNewsletterPharmaRegulation
US FDA Approves Clobetasol Propionate Eye Drops for Postsurgical Pain, Inflammation
US FDA Approves Clobetasol Propionate Eye Drops for Postsurgical Pain, Inflammation

Taiwan-based Formosa Pharmaceuticals announced March 4 that the US FDA had approved clobetasol propionate ophthalmic suspension 0.05% (APP13007) for inflammation and pain following ocular surgery. ...

3/21/2024
NewsletterRefractiveRegulationSurgical
FTC Sends Settlement Notices to Potential Victims of Bait-and-Switch LASIK Ads
FTC Sends Settlement Notices to Potential Victims of Bait-and-Switch LASIK Ads

The Federal Trade Commission has sent notices to about 160 thousand individuals who received LASIK consultations at LasikPlus or Joffe MediCenter that they may be eligible for a settlement payout. ...

3/21/2024
CataractDiagnosticGlaucomaNewsletterRefractiveRegulationRetinaSurgical
Select US FDA Approvals and Clearances in February 2024
Select US FDA Approvals and Clearances in February 2024

The US FDA granted two clearances through the ophthalmic device division using the 510(k) pathway in February 2024, according to the agency’s database. CATS Tonometer received clearance for its ton...

3/21/2024
Dry EyeNewsletterRegulation
Eye Ointments Sold at Walmart, CVS Recalled Due to Infection Risk
Eye Ointments Sold at Walmart, CVS Recalled Due to Infection Risk

India’s Brassica Pharma announced Feb. 12 that it was voluntarily recalling eye ointments sold by retailers such as Walmart and CVS due to a danger of infection. The company said an inspection by t...

3/21/2024
LaserNewsletterOptometryRegulationScope of Practice
South Dakota Expands Optometrists’ Scope to Include SLT, YAG, Incisions
South Dakota Expands Optometrists’ Scope to Include SLT, YAG, Incisions

South Dakota Gov. Kristi Noem on March 4 signed into law a measure expanding the scope of practice of optometrists in the state. HB 1099 allows doctors of optometry to administer injections around ...

3/21/2024
CornealDealsDry EyeIOLIndustryNewsletterRegulationRetina
March 2024 Ophthalmic News Briefs
March 2024 Ophthalmic News Briefs

Germany’s VSY Biotechnology launched its Enova Maestro trifocal toric preloaded intraocular lens (IOL) at the European Society of Cataract and Refractive Surgeons (ESCRS) Winter Meeting, held Feb. ...

3/21/2024
Dry EyeNewsletterRegulation
Weekly Surgeon Poll, March 2024
Weekly Surgeon Poll, March 2024

3/15/2024
BreakingMyopiaRefractiveRegulation
Santen Files for Marketing Approval in Japan for Atropine Drops to Delay Myopia
Santen Files for Marketing Approval in Japan for Atropine Drops to Delay Myopia

Santen Pharmaceutical announced Feb. 28 that it had filed for marketing approval in Japan of DE-127 (0.025% atropine sulfate hydrate eye drop), designed to slow the progression of myopia. The produ...

3/15/2024
BreakingRegulation
US Funding Bill Halves Medicare Reimbursement Cut for Rest of 2024
US Funding Bill Halves Medicare Reimbursement Cut for Rest of 2024

US lawmakers passed a partial government funding bill on March 8 that included a provision mitigating cuts to Medicare physician reimbursement in effect since Jan. 1. The legislation changes the re...

3/15/2024
BreakingLaserOptometryRegulationScope of Practice
South Dakota Expands Optometrists’ Scope to Include SLT, YAG, Incisions
South Dakota Expands Optometrists’ Scope to Include SLT, YAG, Incisions

South Dakota Gov. Kristi Noem on March 4 signed into law a measure expanding the scope of practice of optometrists in the state. HB 1099 allows doctors of optometry to administer injections around ...

3/15/2024
BiosimilarsBreakingRegulationRetina
Formycon’s Ranibizumab Biosimilar Gains Approval in Saudi Arabia, Will Be Marketed as Ravegza
Formycon’s Ranibizumab Biosimilar Gains Approval in Saudi Arabia, Will Be Marketed as Ravegza

Germany’s Formycon announced March 11 that FYB201 (ranibizumab), a biosimilar to Lucentis, had received marketing authorization from the Saudi Food & Drug Authority. Jordan’s MS Pharma is Formycon’...

3/8/2024
BreakingCataractPharmaRegulation
US FDA Approves Clobetasol Propionate Eye Drops for Postsurgical Pain, Inflammation
US FDA Approves Clobetasol Propionate Eye Drops for Postsurgical Pain, Inflammation

Taiwan-based Formosa Pharmaceuticals announced March 4 that the US FDA had approved clobetasol propionate ophthalmic suspension 0.05% (APP13007) for inflammation and pain following ocular surgery. ...

3/8/2024
BreakingRefractiveRegulationSurgical
FTC Sends Settlement Notices to Potential Victims of Bait-and-Switch LASIK Ads
FTC Sends Settlement Notices to Potential Victims of Bait-and-Switch LASIK Ads

The Federal Trade Commission has sent notices to about 160 thousand individuals who received LASIK consultations at LasikPlus or Joffe MediCenter that they may be eligible for a settlement payout. ...

3/8/2024
BreakingCornealRegulationRetina
US FDA Approves Supplemental NDA for Pre-filled Acthar Gel Self-Injector
US FDA Approves Supplemental NDA for Pre-filled Acthar Gel Self-Injector

Ireland-based Mallinckrodt announced March 1 that the US FDA had approved its supplemental new drug application (sNDA) for the H.P. Acthar Gel single-dose pre-filled SelfJect injector. SelfJect pro...

3/1/2024
BreakingDry EyeIndiaRegulation
Eye Ointments Sold at Walmart, CVS Recalled Due to Infection Risk
Eye Ointments Sold at Walmart, CVS Recalled Due to Infection Risk

India’s Brassica Pharma announced Feb. 12 that it was voluntarily recalling eye ointments sold by retailers such as Walmart and CVS due to a danger of infection. The company said an inspection by t...

2/22/2024
NewsletterRegulation
US FDA Warns of Contamination Risk with Copycat Lumify Eye Drops
US FDA Warns of Contamination Risk with Copycat Lumify Eye Drops

The US FDA issued a warning Jan. 31 to consumers not to purchase or use South Moon, Rebright, or FivFivGo eye drops because of the potential risk of eye infection. The products are copycats that ca...

2/22/2024
IndiaNewsletterRegulation
India Orders Tougher Drug-Making Standards After Overseas Deaths
India Orders Tougher Drug-Making Standards After Overseas Deaths

Prime Minister Narendra Modi’s government has stepped up scrutiny of India’s pharmaceutical factories after being stung by a series of overseas deaths linked to Indian-made drugs. The news agency R...

2/22/2024
GlaucomaLaserNewsletterRefractiveRegulation
Select US FDA Approvals and Clearances in January 2024
Select US FDA Approvals and Clearances in January 2024

The US FDA granted two clearances through the ophthalmic device division using the 510(k) pathway in January 2024, according to the agency’s database. Meridian received clearance for three laser mo...

2/22/2024
NewsletterRegulation
CMS is Implementing Time Limit on Prior Authorization Decisions
CMS is Implementing Time Limit on Prior Authorization Decisions

The Centers for Medicare and Medicaid Services (CMS) issued a final rule on Jan. 17 that will limit the amount of time for certain payers to make prior authorization decisions. Payers will have 72 ...

2/22/2024
Clinical TrialNewsletterRegulation
Japan Eases Clinical Trial Requirements for Foreign Drugmakers in Growing Trend
Japan Eases Clinical Trial Requirements for Foreign Drugmakers in Growing Trend

Japan has removed the requirement that foreign drugmakers conduct a Phase I clinical trial in Japan before Japanese individuals participate in Phase III multiregional clinical trials (MRCT) for reg...

2/22/2024
GlaucomaMeetingNewsletterRegulation
Reimbursement Issues for Glaucoma Surgery Remain Threat, G360 Speakers Say
Reimbursement Issues for Glaucoma Surgery Remain Threat, G360 Speakers Say

Attendees of the G360 New Horizons Forum received a detailed breakdown of the battle that the ophthalmic industry collectively waged throughout 2023 to stop proposed limits to Medicare coverage for...

2/22/2024
CataractNewsletterRegulationSurgical
MAC Drops Plan to Require Visual Acuity of 20/50 or Worse for Cataract Surgery
MAC Drops Plan to Require Visual Acuity of 20/50 or Worse for Cataract Surgery

Wisconsin Physician Services (WPS), a Medicare Administrative Contractor (MAC) in the US, has abandoned a proposal to require visual acuity of 20/50 or worse for cataract surgery to be medically ne...

2/22/2024
IndustryNewsletterRegulation
Eyenovia Announces US FDA Clearance of Manufacturing Facility in California
Eyenovia Announces US FDA Clearance of Manufacturing Facility in California

Eyenovia, of New York, announced Feb. 13 that the company’s facility in Redwood City, California, had successfully completed US FDA inspection for approval as a commercial manufacturing facility. T...

2/22/2024
EuropeNewsletterRegulationRetina
Apellis Seeks Re-examination of EU Marketing Application for Pegcetacoplan in GA
Apellis Seeks Re-examination of EU Marketing Application for Pegcetacoplan in GA

Apellis Pharmaceuticals announced Jan. 26 that, as expected, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recom-mended refusal of the company’s marketin...

2/22/2024
CataractClinical TrialCornealDealsDiagnosticDry EyeGene TherapyGlaucomaIOLIndustryNewsletterPresbyopiaRegulationRetinaSurgical
February 2024 Ophthalmic News Briefs
February 2024 Ophthalmic News Briefs

Amneal Pharmaceuticals announced Jan. 10 that it had received US FDA approval for and launched generic fluorometholone eye drops. The product is indicated for the treatment of corticosteroid-respon...

2/16/2024
BreakingClinical TrialCornealRegulation
US FDA Gives Green Light to Phase II Trial of Okyo’s OK-101 in the First IND Cleared for Neuropathic Corneal Pain
US FDA Gives Green Light to Phase II Trial of Okyo’s OK-101 in the First IND Cleared for Neuropathic Corneal Pain

London’s Okyo Pharma announced Feb. 9 that the US FDA had cleared its investigational new drug (IND) application for topical candidate OK-101 in neuropathic corneal pain—a first for that indication...

2/9/2024
BreakingDiagnosticEuropeRegulation
Toku Gains EU, UK Approval for AI Cardiovascular Risk Assessments Through the Eye
Toku Gains EU, UK Approval for AI Cardiovascular Risk Assessments Through the Eye

Toku, of San Diego, California, announced Feb. 5 that it had obtained CE and UK Conformity Assessment (UKCA) marking for its patented CLAiR technology—AI-powered software that identifies elevated c...

2/9/2024
BreakingRegulation
US FDA Warns of Contamination Risk with Copycat Lumify Eye Drops
US FDA Warns of Contamination Risk with Copycat Lumify Eye Drops

The US FDA issued a warning Jan. 31 to consumers not to purchase or use South Moon, Rebright, or FivFivGo eye drops because of the potential risk of eye infection. The products are copycats that ca...

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