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
Chinese Regulators Approve Perfluorohexyloctane Drops for Dry Eye with MGD
China’s Hengrui Pharmaceuticals and Germany’s Novaliq announced July 8 that China’s National Medical Products Administration had approved Heng Qin (perfluorohexyloctane eye drops) for dry eye assoc...
EU Regulators Approve Extended Six-Month Treatment Interval for Eylea 8 mg
German drugmaker Bayer announced June 27 that European regulators had granted a label extension for Eylea (aflibercept) 8 mg with extended treatment intervals of up to six months in wet age-related...
Alcon Unity VCS Dual-Function System Gains Approval in Canada
Alcon announced July 8 that its dual-function Unity Vitreoretinal Cataract System (VCS) had gained market approval from Health Canada. Commercial launch in Canada is expected in early 2026, the com...
Biocon Gains Approval in Canada for Yesafili, a Biosimilar to Eylea
India’s Biocon Biologics announced June 27 that Health Canada regulators had approved Yesafili, an aflibercept (Eylea) biosimilar, for wet age-related macular degeneration, macular edema secondary ...
Aflibercept Biosimilar Candidate from Alvotech Gains Positive CHMP Opinion
Alvotech and partner Advanz Pharma announced June 23 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended approval for AVT06, Alvotech’s propos...
CMS to Increase Audits of Medicare Advantage Billing to Prevent Upcoding
Private insurers that take part in the US Medicare Advantage program will see enhanced and accelerated audits of their billing practices under an aggressive new plan, the Centers for Medicare and M...
Uni-Bio Gains Approval in Japan for Diquafosol Sodium Eye Drops for Dry Eye
Hong Kong-based Uni-Bio Science reported May 21 that it had obtained marketing approval fromthe China National Medical Products Administration for its diquafosol sodium eye drops. Diquafosol sodium...
Health Insurers Pledge to Reform Prior Authorization by 2026
Major insurers of nearly 50 US health plans published a pledge on June 24 to simplify and reduce prior authorization of medical treatments, cutting the volume of treatments subject to such oversigh...
Glaukos Gains EU MDR Certification for Devices in iStent Platform
Glaukos, of Aliso Viejo, California, reported June 25 that it had received European Union (EU) Medical Device Regulation (MDR) certification for devices in its minimally invasive glaucoma surgery (...
Presbyopia Drop Candidate from Viatris and Opus Meets Endpoints in Second Phase III Trial
Commercial partners Viatris and Opus Genetics reported June 26 that their presbyopia drop candidate, MR-141 (phentolamine ophthalmic solution 0.75%), met its primary endpoint and key secondary endp...
US FDA Gives Green Light to Phase III Trial of Zhaoke’s Cyclosporine Ophthalmic Gel
Hong Kong’s Zhaoke Ophthalmology announced June 4 that the US FDA had cleared the investigational new drug (IND) application for its 0.05% cyclosporine ophthalmic gel, targeting moderate to severe ...
Amneal Gains US FDA Approval for Generic Prednisolone Acetate Eye Drop
Amneal Pharmaceuticals announced June 12 that it had received US FDA approval for its generic prednisolone acetate ophthalmic suspension, 1%, which references AbbVie’s Pred Forte. The sterile, topi...
VivaVision, US FDA Agree on Accelerated Path for Post-op Inflammation Candidate
VivaVision, of Wenzhou, China, announced June 9 that the US FDA had agreed on an accelerated regulatory pathway for the company’s VVN461LD, a potent JAK1/TYK2 inhibitor targeting inflammation follo...
Scottish Regulators Endorse Outlook’s Lytenava for NHS Scotland Use in Wet AMD
Outlook Therapeutics announced June 10 that the Scottish Medicines Consortium had recommended Lytenava (bevacizumab gamma) for use within its National Health Service system, NHS Scotland, for the t...
Talks on Pharma Reforms Cloud Future of Europe’s Health Care Market
The European Council—made up of the heads of the European Union’s member states—on June 4 advanced its position on pharmaceutical reforms, teeing up negotiations with the European Parliament and Co...
US FDA Approves Alcon’s Tryptyr (Acoltremon) Drops for Dry Eye
Alcon announced May 28 that the US FDA had approved Tryptyr (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512, for the treatment of the signs and symptoms of dry eye. The company ...
Allotex Launches Refractive Corneal Implant in Canada
Allotex announced May 22 the approval and launch in Canada of Transform, its human collagen-based corneal implant for vision correction. The company said it had partnered with Clarion Medical Techn...
Select US FDA Approvals and Clearances in May 2025
The US FDA’s ophthalmic device division granted clearance to one company’s technology using the 510(k) pathway in May 2025, according to the agency’s database. Heidelberg Engineering gained clearan...
Atia Vision Gains IDE Approval to Begin US Trial of Modular Accommodating IOL
Atia Vision announced May 20 that the FDA had approved its investigational device exemption (IDE) application to begin a US feasibility study of its OmniVu modular accommodating lens system for cat...
ARVO Attendees Share Concern Over Present and Future of Vision Research
The tidal wave of sudden cuts and restrictions to funding for vision and ophthalmic research cast a long shadow over the 2025 ARVO meeting. They came up formally and informally throughout the six-d...
Eyecelerator Meeting’s Expert Panelists Portray an FDA in Flux
A panel at the Eyecelerator meeting on May 2 ahead of ARVO brought together a deeply experienced and knowledgeable group to examine the recent changes at the US FDA and their impact on the ophthalm...
Sydnexis Gains EU Approval for Low-Dose Atropine Drops in Pediatric Myopia
Sydnexis announced June 5 that the European Commission had granted marketing authorization for SYD-101, the company’s low-dose atropine formulation for slowing the progression of pediatric myopia. ...
PDUFA Dates for Ophthalmic Drug Candidates, June 2025
The US FDA has scheduled the following Prescription Drug User Fee Act (PDUFA) target action dates for ophthalmic drug, drug/device, and biologic candidates.
Weekly Corporate and Surgeon Polls, June 2025
June 2025 Ophthalmic News Briefs
Bausch + Lomb announced June 4 the US launch of Blink Nourish and Blink Boost over-the-counter lubricating eye drops. Both products are preservative-free and come in a 10 mL multi-dose bottle. Blin...
US FDA Aims to Speed Drug Review to Under Two Months With New Voucher Program
The US FDA reported June 17 the launch of a new priority review voucher program designed to review prescription drug applications within one to two months of submission. The current average is 10 t...
Aldeyra Resubmits NDA to US FDA for Reproxalap in Dry Eye
Aldeyra Therapeutics announced June 17 that it had resubmitted its new drug application (NDA) to the US FDA for topical ocular reproxalap in dry eye. Aldeyra reported in May that reproxalap achieve...
US FDA Gives Green Light to Phase II/III Trial of Ocugen’s Stargardt Candidate
Ocugen announced June 16 that the US FDA had cleared an investigational new drug (IND) application for a Phase II/III trial of its OCU410ST subretinal gene therapy candidate for ABCA4-associated re...
Chinese Regulators Approve Clarus 700 Ultra-Widefield Fundus Camera from Zeiss
Germany’s Carl Zeiss Meditec announced June 6 that China’s National Medical Products Administration (NMPA) had approved the Clarus 700 high-definition, ultra-widefield fundus imaging system. The co...
ViGeneron Rebrands as VeonGen, Gains Rare Pediatric Nod for Stargardt Candidate
Germany’s ViGeneron announced June 5 its rebranding to VeonGen Therapeutics. VeonGen has advanced two gene therapy programs into clinical development—VG801 for Stargardt disease and other ABCA4-rel...
FDA Begins Listening Tour with Pharma CEOs to Improve Regulatory Process
The US FDA is holding a listening tour, led by FDA Commissioner Marty A. Makary, MD, MPH,to meet directly with pharmaceutical and biotech CEOs, according to an announcement on May 28. The goal is t...
US FDA Accepts Tenpoint’s NDA for Presbyopia Drop, Sets PDUFA Date of Jan. 28, 2026
Tenpoint Therapeutics announced June 3 that the US FDA had accepted its new drug application (NDA) for Brimochol PF, a combination eye drop candidate targeting presbyopia. The FDA set a Prescriptio...
US FDA Approves Alcon’s Tryptyr (Acoltremon) Drops for Dry Eye
Alcon announced May 28 that the US FDA had approved Tryptyr (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512, for the treatment of the signs and symptoms of dry eye. The company ...
US FDA Sets Decision Date of Oct. 21 for Xbrane’s Lucentis Biosimilar Candidate
Sweden’s Xbrane Biopharma announced May 23 that the US FDA had accepted the resubmitted biologics license application (BLA) for its Lucentis (ranibizumab) biosimilar. The FDA set a decision date of...
Deepeye TPS AI Support Tool for Wet AMD Treatment Gains CE Marking
Germany’s Deepeye Medical announced May 21 that its Deepeye TPS artificial intelligence assistant had been granted CE marking in the EU as a Class IIa medical device. The company said medical assis...
iVeena Submits IND to US FDA for Phase II Trial of IVMED-85 in Pediatric Myopia
iVeena Delivery Systems announced May 29 that it had submitted an investigational new drug (IND) application to the US FDA for a Phase II trial of IVMED-85 in pediatric myopia. IVMED-85 is a non-at...
Allotex Launches Refractive Corneal Implant in Canada
Allotex announced May 22 the approval and launch in Canada of Transform, its human collagen-based corneal implant for vision correction. The company said it had partnered with Clarion Medical Techn...
US FDA Grants Rare Pediatric Designation to Ocugen’s Gene Therapy Candidate for Stargardt
Ocugen announced May 27 that the US FDA had granted rare pediatric disease designation to its OCU410ST subretinal gene therapy candidate for ABCA4-associated retinopathies, including Stargardt dise...
Atia Vision Gains IDE Approval to Begin US Trial of Modular Accommodating IOL
Atia Vision announced May 20 that the FDA had approved its investigational device exemption (IDE) application to begin a US feasibility study of its OmniVu modular accommodating lens system for cat...
US FDA Gives Green Light to Phase II Trial of Immunoglobulin Eye Drop from Selagine, Grifols
Chicago-based Selagine and its partner Grifols, of Barcelona, Spain, announced May 21 that the US FDA had cleared an investigational new drug (IND) application for a Phase II trial of their GRF312 ...
SIFI Gains Marketing Authorization, PIM Designation for Akantior Drops in UK
Italy’s SIFI reported May 19 that it had gained marketing authorization from the UK’s Medicines and Healthcare Products Regulatory Agency for Akantior eye drops for the treatment of Acanthamoeba ke...
US FDA Approves Genentech’s Susvimo Refillable Implant for DR
Genentech, a member of the Roche Group, announced May 22 that the US FDA had approved Susvimo, a refillable ranibizumab implant, for diabetic retinopathy (DR). The South San Francisco, California, ...
US FDA Grants Breakthrough Status to Belite Bio’s Oral Stargardt Candidate
Belite Bio announced May 21 that the US FDA had granted breakthrough therapy status to tinlarebant, an oral tablet targeting Stargardt disease. Sponsor companies receiving breakthrough designation ...
Bausch + Lomb Ends Recall of enVista IOLs After Tracking Source of Contamination
Bausch + Lomb announced April 24 that it was ending its voluntary recall of enVista intraocular lenses (IOLs) after it tracked the source of contamination to a raw material used in certain lots tha...
Bausch + Lomb Receives CE Marking for Preloaded LuxLife Trifocal IOL
Bausch + Lomb announced May 7 that the LuxLife trifocal intraocular lens (IOL) had received CE marking in Europe. The company said the nondiffractive LuxLife has an uninterrupted, continuous refrac...
Select US FDA Approvals and Clearances in April 2025
Device makers gained US FDA clearance for seven technologies through the ophthalmic device division using the 510(k) pathway in April 2025, according to the agency’s database. BVI Medical received ...
Nearly 76 Thousand Cases of Ocular Lubricants Recalled, US FDA Alert Says
The US FDA issued alerts recently regarding the recalls of five ocular lubricant products and one generic glaucoma medication. BRS Analytical Services, a contract testing laboratory based in St. Lo...
Ballooning NHS Cataract Surgery Costs at Private Clinics Raise Red Flags
Fraud investigators in England’s National Health Service (NHS) are looking at the billing practices of private clinics delivering NHS cataract surgery after procedure volume and costs have balloone...
Four Eylea Biosimilars Get Q-Codes for Billing Payers in the US
The Centers for Medicare and Medicaid Services (CMS) issued product-specific Q-codes for four Eylea biosimilars during Q4-2024 and Q1-2025. Q-codes are billing codes for reimbursement that are simi...
US Policy Decisions Add Uncertainty to Ophthalmic Industry
The ophthalmic industry is facing uncertainty from US government policies on at least three fronts: an executive order designed to lower drug pricing, continually changing tariffs, and a budget bil...
May 2025 Ophthalmic News Briefs
London’s Okyo Pharma announced April 30 that it would accelerate development of topical urcosimod, formerly OK-101, in neuropathic corneal pain, following early closure of its Phase II trial. The t...
Nearly 76 Thousand Cases of Ocular Lubricants Recalled, US FDA Alert Says
The US FDA issued alerts recently regarding the recalls of five ocular lubricant products and one generic glaucoma medication. BRS Analytical Services, a contract testing laboratory based in St. Lo...
Intalight Receives CE Marking for Dream OCT Swept Source Imaging
Ophthalmic diagnostic company Intalight announced May 15 that it had received CE marking for its Dream optical coherence tomography (OCT) platform. Intalight, with offices in San Jose, California, ...
Bausch + Lomb Receives CE Marking for Preloaded LuxLife Trifocal IOL
Bausch + Lomb announced May 7 that the LuxLife trifocal intraocular lens (IOL) had received CE marking in Europe. The company said the nondiffractive LuxLife has an uninterrupted, continuous refrac...
US FDA Grants Breakthrough Status to Viridian’s Thyroid Eye Disease Candidate
Viridian Therapeutics announced May 7 that the US FDA had granted breakthrough therapy status to veligrotug, the company’s anti-insulin-like growth factor-1 receptor (IGF-1R) candidate for thyroid ...
US FDA Grants Marketing Clearance for OcuSciences’ OcuMet Beacon Retinal Imager
OcuSciences, of Ann Arbor, Michigan, announced May 1 that the US FDA had granted marketing clearance for its flagship device, the OcuMet Beacon retinal imager. The 510(k) clearance describes the Oc...
RetinAI and FVS Gain CE Marking for LuxIA DR Screening Algorithm
Switzerland’s RetinAI and Spain’s Fundación Ver Salud (FVS) announced April 30 that LuxIA, their co-developed artificial intelligence algorithm for diabetic retinopathy screening, had received CE m...
Aldeyra Achieves Primary Endpoint in Phase III Dry Eye Chamber Trial of Reproxalap, Plans NDA Resubmission
Aldeyra Therapeutics reported May 5 that topical reproxalap achieved the primary endpoint of statistically significant improvement in ocular discomfort vs. vehicle in a Phase III dry eye chamber tr...
US FDA Grants RMAT Status to Opus’ LCA5 Gene Therapy Candidate
Opus Genetics announced May 6 that the US FDA had granted regenerative medicine advanced therapy (RMAT) designation to OPGx-LCA5, its investigational gene therapy for the treatment of Leber congeni...
US FDA Grants RMAT Status to 4DMT’s Gene Therapy Candidate in DME
4D Molecular Therapeutics announced May 1 that the US FDA had granted regenerative medicine advanced therapy (RMAT) designation to 4D-150, an intravitreal gene therapy candidate for diabetic macula...
US FDA Extends Luminopia Amblyopia Treatment Clearance to Children Ages 8 to 12
Luminopia announced April 22 that the US FDA had cleared its amblyopia (lazy eye) treatment for patients ages 8 to 12, extending the age range of its existing label. The Luminopia system was grante...
New Laws in Montana, West Virginia Expand ODs’ Scope to Include Laser
Montana and West Virginia became the 13th and 14th US states, respectively, to pass laws expanding optometrists’ scope of practice to include in-office laser procedures. West Virginia’s measure spe...
Bausch + Lomb Ends Recall of enVista IOLs After Tracking Source of Contamination
Bausch + Lomb announced April 24 that it was ending its voluntary recall of enVista intraocular lenses (IOLs) after it tracked the source of contamination to a raw material used in certain lots tha...
Four Eylea Biosimilars Get Q-Codes for Billing Payers in the US
The Centers for Medicare and Medicaid Services (CMS) issued product-specific Q-codes for four Eylea biosimilars during Q4-2024 and Q1-2025. Q-codes are billing codes for reimbursement that are simi...
US FDA Rejects Regeneron’s sBLA for Eylea HD Dosing Interval Beyond 16 Weeks
Regeneron announced April 18 that the US FDA had issued a complete response letter rejecting the company’s supplemental biologics license application (sBLA) to add extended dosing intervals up to e...
Ballooning NHS Cataract Surgery Costs at Private Clinics Raise Red Flags
Fraud investigators in England’sNational Health Service (NHS) are looking at the billing practices of private clinics delivering NHS cataract surgery after procedure volume and costs have ballooned...
New Mexico Governor Vetoes Bill to Allow ODs to Perform SLT, YAG Capsulotomy
New Mexico Gov. Michelle Lujan Grisham on April 11 vetoed House Bill 36, which would have expanded the scope of practice for optometrists in the state, allowing them to perform selective laser trab...
US FDA Again Rejects Aldeyra’s Reproxalap for Dry Eye, Asks for Yet Another Symptom Trial
Aldeyra Therapeutics reported April 3 that the US FDA had once again issued a complete response letter rejecting the company’s new drug application (NDA) for topical reproxalap as a treatment for d...
Select US FDA Approvals and Clearances in March 2025
There was one US FDA clearance through the ophthalmic device division using the 510(k) pathway in March 2025, according to the agency’s database. CenterVue gained approval for its Maia scanning las...
Nordic Pharma Secures CE Marking for Lacrifill Canalicular Gel in Dry Eye
Nordic Group B.V., a Dutch affiliate of Nordic Pharma, announced April 7 that Lacrifill canalicular gel had received CE marking in Europe for the treatment of dry eye. Lacrifill is a cross-linked h...
PDUFA Dates for Ophthalmic Drug Candidates, April 2025
The US FDA has scheduled the following Prescription Drug User Fee Act (PDUFA) target action dates for ophthalmic drug, drug/device, and biologic candidates.
US FDA Accepts Outlook’s Resubmitted BLA for Lytenava, Sets PDUFA Date of Aug. 27
Outlook Therapeutics announced April 8 that the US FDA had accepted the resubmitted biologics license application (BLA) for ONS-5010 (bevacizumab-vikg, Lytenava), an ophthalmic formulation of bevac...
Malvina Eydelman, MD, Named CEO of CCOI Organization
Longtime US FDA regulator and board-certified ophthalmologist Malvina Eydelman, MD, has stepped into a new role as chief executive officer of the Collaborative Community on Ophthalmic Innovation (C...
Job and Funding Cuts in US HHS Department Hit Ophthalmic Community
The Trump administration’s overhaul of the US Health and Human Services Department (HHS) through mass firings, funding cuts, and restructuring continues to affect those working to protect vision. J...
Bausch + Lomb Recalls Certain enVista IOLs Amid Reports of TASS Cases
Bausch + Lomb announced March 27 that it was voluntarily recalling certain intraocular lenses (IOLs) on its enVista platform. A letter to customers from Bausch + Lomb Chairman and CEO Brent Saunder...
US FDA Plans to Phase Out Animal Testing for Biologics, Drugs
The US FDA reported April 10 that it planned to phase out animal testing as part of the approval process for biologics and drugs, as the agency moves to more effective, human-relevant methods, call...
April 2025 Ophthalmic News Briefs
Carl Zeiss Meditec announced March 21 the availability in Canada of the Visulas Combi, a green and YAG ophthalmic laser workstation combining photodisruption, photocoagulation, and slit lamp techno...
US FDA Grants 510(k) Clearance to BVI’s Laser Endoscopy System for Glaucoma
BVI Medical announced April 17 that it had received US FDA 510(k) clearance for its Leos laser endoscopy system for glaucoma. The company said Leos offers a more intuitive, minimally invasive ab in...
Sanoculis Receives CE Marking for MINT Procedure for Glaucoma
Israel’s Sanoculis announced April 17 that it had received CE marking in the EU for its MINT (minimally invasive nasal trabeculostomy) procedure for adults with glaucoma. MINT features a mechanical...
US FDA Plans to Phase Out Animal Testing for Biologics, Drugs
The US FDA reported April 10 that it planned to phase out animal testing as part of the approval process for biologics and drugs, as the agency moves to more effective, human-relevant methods, call...
ACRO Biomedical Gains Regulatory Approval in Taiwan for Corneal Xenograft
Taiwan’s ACRO Biomedical announced April 13 that the country’s Ministry of Health and Welfare had granted regulatory approval to ACRO’s ABCcolla decellularized porcine collagen corneal xenograft. A...
US FDA Grants RMAT Status to Atsena’s X-Linked Retinoschisis Gene Therapy Candidate
Atsena Therapeutics announced April 15 that the US FDA had granted regenerative medicine advanced therapy (RMAT) designation to ATSN-201, its gene therapy candidate for X-linked retinoschisis (XLRS...
Tenpoint Submits NDA to US FDA for Brimochol PF in Presbyopia
Tenpoint Therapeutics announced April 8 that it had submitted a new drug application (NDA) to the US FDA for Brimochol PF, a combination eye drop candidate targeting presbyopia. In its Phase III tr...
Nordic Pharma Secures CE Marking for Lacrifill Canalicular Gel in Dry Eye
Nordic Group B.V., a Dutch affiliate of Nordic Pharma, announced April 7 that Lacrifill canalicular gel had received CE marking in Europe for the treatment of dry eye. Lacrifill is a cross-linked h...
US FDA Accepts Outlook’s Resubmitted BLA for Lytenava, Sets PDUFA Date of Aug. 27
Outlook Therapeutics announced April 8 that the US FDA had accepted the resubmitted biologics license application (BLA) for ONS-5010 (bevacizumab-vikg, Lytenava), an ophthalmic formulation of bevac...
Chinese Regulators Approve Tapcom Fixed-Combo Glaucoma Drop from Santen
Japan’s Santen announced April 4 that China’s National Medical Products Administration had approved the marketing authorization application for Tapcom (tafluprost 0.0015%/timolol maleate 0.5% ), a ...
US FDA Again Rejects Aldeyra’s Reproxalap for Dry Eye, Asks for Yet Another Symptom Trial
Aldeyra Therapeutics reported April 3 that the US FDA had once again issued a complete response letter rejecting the company’s new drug application (NDA) for topical reproxalap as a treatment for d...
Malvina Eydelman, MD, Named CEO of CCOI Organization
Longtime US FDA regulator and board-certified ophthalmologist Malvina Eydelman, MD, has stepped into a new role as chief executive officer of the Collaborative Community on Ophthalmic Innovation (C...
Sydnexis Receives Positive CHMP Opinion for Low-Dose Atropine Drops in Pediatric Myopia
Sydnexis announced April 1 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended marketing authorization in the European Union for its low-dose ...
Bausch + Lomb Recalls Certain enVista IOLs Amid Reports of TASS Cases
Bausch + Lomb announced March 27 that it was voluntarily recalling certain intraocular lenses (IOLs) on its enVista platform. A letter to customers from Bausch + Lomb Chairman and CEO Brent Saunder...
Alcon Announces CE Mark Approval, European Launch of Clareon Vivity IOL
Alcon reported March 25 that the Clareon Vivity extended depth of focus (EDOF) intraocular lens (IOL) had received CE marking, along with the toric model, and will begin a commercial rollout in Eur...
Chinese Regulators Approve DORC’s ILM-Blue Ocular Dye
German company Carl Zeiss Meditec announced March 27 that China’s National Medical Products Administration (NMPA) had approved ILM-Blue ocular dye from DORC. The product is approved in the US as Ti...
US FDA Expands Label for Iluvien to Include Chronic Non-infectious Posterior Uveitis
ANI Pharmaceuticals, of Baudette, Minnesota, announced March 14 that the US FDA had approved an expanded label for Iluvien (fluocinolone acetonide intravitreal implant 0.19 mg) to include treatment...
Chinese Regulators Approve Innovent’s Sycume for Thyroid Eye Disease
China’s Innovent Biologics announced March 14 that Chinese regulators had approved Sycume, a recombinant anti-insulin-like growth factor 1 receptor antibody for thyroid eye disease (TED). Innovent ...
Changes in NIH Grant Rules Threaten to Ripple Through Eye Disease Research
Any changes to the rules that accompany US government research grants could affect eye research in the US in a big way. The US government awards an average of $1.1 billion a year in grants to resea...
US FDA Approves Neurotech’s Cell Therapy Implant for MacTel
Neurotech Pharmaceuticals announced March 6 that the US FDA had approved Encelto, an encapsulated cell therapy implant to treat macular telangiectasia (MacTel) type 2. It’s the first FDA-approved t...
PDUFA Dates for Ophthalmic Drug Candidates
The US FDA has scheduled the following Prescription Drug User Fee Act (PDUFA) target action dates for ophthalmic drug, drug/device, and biologic candidates.
Select US FDA Approvals and Clearances in February 2025
There was one US FDA clearance through the ophthalmic device division using the 510(k) pathway in February 2025, according to the agency’s database. New World Medical gained clearance of its Via360...
US FDA Accepts NDA for Glaukos’ Epioxa for Epi-On Crosslinking Therapy
Glaukos, of Aliso Viejo, California, reported Feb. 24 that the US FDA had accepted its new drug application for Epioxa, an epi-on version of the company’s iLink corneal crosslinking therapy, for th...
New Arkansas Law Reins in Vision Care Insurers’ Influence over ODs
Optometrists in Arkansas celebrated a legislative victory on Feb. 25 when Gov. Sarah Huckabee Sanders signed into law HB 1353, which supporters say will allow ODs in the state to receive more fair ...
Medicare Physician Fee Cut Won’t be Rolled Back in March
US House members on March 9 dropped language from a stopgap funding bill that would have rolled back the 2.83 percent cut in Medicare reimbursement for doctors that went into effect Jan. 1. The mov...
New World Medical Gains US Clearance for the Via360 Viscodilation System for Glaucoma
New World Medical announced Feb. 18 that it had received 510(k) clearance from the US FDA for its Via360 glaucoma surgical system. The Rancho Cucamonga, California, company said the device would be...
Weekly Corporate and Surgeon Poll, March 2025
March 2025 Ophthalmic News Briefs
Alcon announced the US launch Feb. 24 of its Systane Pro Preservative-Free (PF) over-the-counter eye drops for dry eye. The company said Systane Pro PF is the longest lasting eye drop in the Systan...
US FDA Accepts NDA for Sydnexis’ Low-Dose Atropine for Myopia, Sets PDUFA Date of Oct. 23, 2025
Sydnexis, of Del Mar, California, reported March 11 that the US FDA had accepted its new drug application for SYD-101, a low-dose atropine eye drop to slow the progression of pediatric myopia. The ...
US FDA Grants Fast Track Status to Atsena’s X-Linked Retinoschisis Gene Therapy Candidate
Atsena Therapeutics announced March 12 that the US FDA had granted fast track designation to ATSN-201, its gene therapy candidate for X-linked retinoschisis (XLRS). The candidate previously receive...
US FDA Approves Neurotech’s Cell Therapy Implant for MacTel
Neurotech Pharmaceuticals announced March 6 that the US FDA had approved Encelto, an encapsulated cell therapy implant to treat macular telangiectasia (MacTel) type 2. It’s the first FDA-approved t...
Outlook Resubmits BLA to US FDA for Ophthalmic Bevacizumab (Lytenava)
Outlook Therapeutics reported Feb. 28 that it had resubmitted its biologics license application (BLA) to the US FDA for ONS-5010 (Lytenava), an ophthalmic formulation of bevacizumab for wet age-rel...
US FDA Approves ANI Pharmaceuticals’ Cortrophin Gel in Prefilled Syringe
ANI Pharmaceuticals announced March 3 that the US FDA had approved a prefilled syringe of its purified Cortrophin gel. Among its many indications, the treatment targets acute and chronic inflammato...
Avirmax Initiates IND-Enabling Studies of Dry AMD Triple-Gene Therapy Candidate
Avirmax Biopharma announced Feb. 28 that it had begun investigational new drug (IND) enabling studies of ABI-201, a viral vector that delivers three genes with the goal of preventing retinal pathog...
Japanese Regulators Grant Orphan Drug Status to HanAll’s Batoclimab in Active Thyroid Eye Disease
South Korea’s HanAll Biopharma announced March 6 that Japanese regulators had granted orphan drug designation to batoclimab, a subcutaneous anti-FcRn treatment being developed for autoimmune diseas...
Ocugen’s Gene Therapy Candidates for GA and Stargardt Gain Advanced Therapy Status in Europe
Ocugen announced March 3 that European regulators had granted advanced therapy medicinal product status to OCU410 and OCU410ST, the company’s subretinal gene therapy candidates for geographic atrop...
US FDA Accepts NDA for Glaukos’ Epioxa, Sets PDUFA Date of Oct. 20, 2025
Glaukos, of Aliso Viejo, California, reported Feb. 24 that the US FDA had accepted its new drug application for Epioxa, an epi-on version of the company’s iLink corneal crosslinking therapy, for th...
Chinese Regulators Approve Zeiss’ VisuMax 800 with SMILE Pro Software
Germany’s Carl Zeiss Meditec announced Feb. 26 that the National Medical Products Administration in China had approved its updated VisuMax 800 femtosecond refractive laser and related SMILE Pro sof...
Formycon, Klinge Gain UK Approval for Eylea Biosimilar Under Brand Name Ahzantive
German companies Formycon and Klinge Biopharma announced Feb. 25 that the UK’s Medicines and Healthcare Products Regulatory Agency had granted marketing authorization for their Eylea biosimilar und...
Chinese Regulators Accept NDA for Arcatus (Xipere) in Uveitic Macular Edema
Clearside Biomedical announced Feb. 20 that Chinese regulators had accepted for review the new drug application (NDA) filed by Clearside’s Asia-Pacific partner, Arctic Vision, for Arcatus, known as...
Opus Gains FDA Fast Track Status for Phentolamine Drops for Night Driving Impairment
Opus Genetics announced Feb. 26 that the US FDA had granted fast track designation to the company’s phentolamine eye drop candidate for night driving impairment in keratorefractive patients. Ocuphi...
Celltrion Gains EU Approval for Aflibercept Biosimilar Branded Eydenzelt
South Korea’s Celltrion announced Feb. 18 that the European Commission had granted marketing authorization to Eydenzelt, an aflibercept (Eylea) biosimilar. Eydenzelt (40 mg/mL solution for injectio...
US FDA Grants RMAT Designation for Bionic Sight’s RP Gene Therapy Candidate
Bionic Sight announced Feb. 18 that the US FDA had granted regenerative medicine advanced therapy (RMAT) designation to BS01, the company’s gene therapy candidate targeting retinitis pigmentosa (RP...
US FDA Accepts BLA for Aflibercept Biosimilar Candidate from Alvotech, Teva
Alvotech announced Feb. 18 that the US FDA had accepted for review its biologics license application (BLA) for AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept). The company said it expe...
US FDA Grants RMAT Designation for Luxa’s Dry AMD Cell Therapy Candidate
Luxa Biotechnology, a joint venture between Korea’s Y2 Solutions and the Neural Stem Cell Institute in Rensselaer, New York, announced Feb. 18 that the US FDA had granted regenerative medicine adva...
Australian Regulators Approve Apellis’ Syfovre for Patients with Geographic Atrophy
Apellis Pharmaceuticals announced Jan. 27 that Australia’s Therapeutic Goods Administration had approved Syfovre (intravitreal pegcetacoplan) for the every-other-month treatment of adult patients w...
Appeals Court Upholds Injunctions Blocking Eylea Biosimilars from Samsung Bioepis and Formycon
In a victory for Regeneron, the US Court of Appeals for the Federal Circuit issued a ruling Jan. 29 upholding preliminary injunctions that block Samsung Bioepis and Formycon from launching their ap...
Select US FDA Approvals and Clearances in January 2025
There were no US FDA clearances through the ophthalmic device division using the 510(k) pathway in January 2025, according to the agency’s database. This is a departure from previous months, when i...
US FDA Approves Expanded Label for Izervay to Extend Treatment for GA Beyond 12 Months
Japan’s Astellas Pharma announced Feb. 12 that the US FDA had approved expanded labeling for Izervay (avacincaptad pegol intravitreal solution) for geographic atrophy (GA), extending the allowed du...
Ophthalmology Officials, Doctors, Researchers Feel Effects of Trump’s Sweeping Changes
The US ophthalmic community and larger health care industry have been affected by many policies implemented by the Trump administration since inauguration day on Jan. 20. Among the 3,600 employees ...
February 2025 Ophthalmic News Briefs
Outlook Therapeutics reported Jan. 16 the final results of the NORSE EIGHT trial of ONS-5010 (Lytenava), an ophthalmic formulation of bevacizumab for wet AMD. ONS-5010 demonstrated non-inferiority ...
US FDA Approves Expanded Label for Izervay to Extend Treatment for GA Beyond 12 Months
Japan’s Astellas Pharma announced Feb. 12 that the US FDA had approved expanded labeling for Izervay (avacincaptad pegol intravitreal solution) for geographic atrophy (GA), extending the allowed du...
US FDA Grants RMAT Designation for Beacon’s XLRP Gene Therapy Candidate
Beacon Therapeutics announced Jan. 28 that the US FDA had granted regenerative medicine advanced therapy (RMAT) designation to laru-zova (laruparetigene zovaparvovec, also known as AGTC-501), Beaco...
Ocugen’s RP Gene Therapy Candidate Gains Advanced Therapy Status in Europe
Ocugen announced Feb. 3 that European regulators had granted advanced therapy medicinal product status to OCU400, a modifier gene therapy candidate for retinitis pigmentosa (RP). OCU400 (AAV-NR2E3)...
Appeals Court Upholds Injunctions Blocking Eylea Biosimilars from Samsung Bioepis and Formycon
In a victory for Regeneron, the US Court of Appeals for the Federal Circuit issued a ruling Jan. 29 upholding preliminary injunctions that block Samsung Bioepis and Formycon from launching their ap...
US FDA Approves Genentech’s Susvimo Refillable Implant for DME
Genentech, a member of the Roche Group, announced Feb. 4 that the US FDA had approved Susvimo, a refillable ranibizumab implant, for diabetic macular edema (DME). The company said Susvimo is now av...
Australian Regulators Approve Apellis’ Syfovre for Geographic Atrophy
Apellis Pharmaceuticals announced Jan. 27 that Australia’s Therapeutic Goods Administration had approved Syfovre (intravitreal pegcetacoplan) for the every-other-month treatment of adult patients w...
Aflibercept Biosimilar Candidate from Amgen Gains Positive CHMP Opinion
Europe’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion Jan. 30 for an aflibercept (Eylea) biosimilar from Amgen, under the names Pavblu and Skojoy. The biosimilar ...
Chinese Regulators Accept Marketing Application for Zhaoke’s Low-Dose Atropine Drop for Myopia
Vyluma announced Jan. 29 that China’s National Medical Products Administration had accepted the marketing application from Zhaoke Ophthalmology for NVK002 (low-dose atropine 0.01%) targeting myopia...
Norlase Receives US Clearance and CE Marking for Lynx Pattern Scanning Laser Indirect Ophthalmoscope
Norlase announced Jan. 27 the commercial launch of the Lynx, which the company says is the world’s first laser indirect ophthalmoscope with integrated pattern scanning capabilities for photocoagula...
Outlook Reports Final Results of Lytenava Trial, Plans BLA Resubmission in Q1-2025
Outlook Therapeutics reported Jan. 16 the final results of the NORSE EIGHT trial of ONS-5010 (Lytenava), an ophthalmic formulation of bevacizumab for wet age-related macular degeneration (AMD). ONS...
US FDA Grants Rare Pediatric Designation to MeiraGTx’ LCA1 Gene Therapy Candidate
MeiraGTx, with offices in London and New York, announced Jan. 22 that the US FDA had granted rare pediatric disease designation to its AAV8-RK-RetGC gene therapy candidate for Leber congenital amau...
US FDA Grants Fast Track Status to Nacuity’s Oral RP Candidate
Nacuity Pharmaceuticals announced Jan. 21 that the US FDA had granted fast track designation to NPI-001 (N-acetylcysteine amide) tablets, Nacuity’s oral retinitis pigmentosa (RP) treatment candidat...
Repka Plans to Use AAO Presidency to Push for Medicare Payment Reform
Michael X. Repka, MD, MBA, the new president of the American Academy of Ophthalmology, plans to make Medicare payment reform his top priority during his one-year term. Medicare reimbursement to US ...
Health Canada Approves Rayner’s RayOne EMV Toric IOL
UK-based Rayner announced Jan. 21 that Health Canada had approved the toric version of its RayOne EMV enhanced monofocal intraocular lens (IOL). The non-toric version of the lens was approved in Ca...
Formycon, Klinge Gain EU Approval for Eylea Biosimilar Under Brand Names Ahzantive and Baiama
German companies Formycon and Klinge Biopharma announced Jan. 20 that the European Commission had granted marketing authorization for their Eylea biosimilar, under the brand names Ahzantive and Bai...
Arctic Vision Gains Approval of Arcatus (Xipere) for Uveitic Macular Edema in Australia, Singapore
Clearside Biomedical announced Jan. 22 that its Asia-Pacific partner, Arctic Vision, had gained approval in Australia and Singapore for Arcatus, known as Xipere in the US, for uveitic macular edema...
Senju Files for Marketing Approval of Dry Eye Candidate SJP-0132 in Japan
Japan’s Senju Pharmaceutical announced Jan. 17 that it had submitted a marketing application in Japan for SJP-0132, a TRPV1 antagonist eye drop candidate targeting dry eye. TRPV1 antagonists have a...
Select US FDA Approvals and Clearances in December 2024
The US FDA granted four clearances through the ophthalmic device division using the 510(k) pathway in December 2024, according to the agency’s database. AI Optics gained clearance for its Sentinel ...
Glaukos Submits NDA for Epioxa Epi-On Crosslinking Treatment
Glaukos, of Aliso Viejo, California, reported Dec. 23 that it had submitted its new drug application to the US FDA for Epioxa, an epi-on version of the company’s iLink corneal crosslinking therapy,...
US FDA PDUFA Dates for Ophthalmic Drug Candidates
The US FDA has scheduled the following Prescription Drug User Fee Act (PDUFA) target action dates for ophthalmic drug, drug/device, and biologic candidates.
2024 in Review: MAC Turmoil Shakes Out with Final Policy on Coverage of MIGS
Five of the seven US Medicare Contract Administrators ended a two-year roller coaster ride for the glaucoma surgery market in mid-November by publishing for the second time their final coverage pla...
2024 in Review: LumiThera’s Valeda is First Treatment for Early, Intermediate Dry AMD
The US FDA granted market authorization to LumiThera’s Valeda Light Delivery System as a de novo device on Nov. 4, making it the first treatment of any kind, device or drug, to receive the FDA’s ba...
2024 in Review: Change Healthcare and Hoya Data Breaches Highlight Security Risks
The health care and public health sector was the most common ransomware target of any critical US infrastructure sector in 2023 and 2024, according to the FBI. By October 2024, the American Hospita...
January 2025 Ophthalmic News Briefs
China’s Eyebright Medical announced Jan. 7 that its phakic intraocular lens, the Loong Crystal PR, had received certification as a Class III medical device from the country’s National Medical Produ...
Eyebright Medical Gains Certification in China for Phakic IOL
China’s Eyebright Medical announced Jan. 7 that its phakic intraocular lens, the Loong Crystal PR, had received certification as a Class III medical device from the country’s National Medical Produ...
US FDA Grants Rare Pediatric Disease Designation to ViGeneron’s RP Gene Therapy Candidate
Germany’s ViGeneron announced Jan. 8 that the US FDA had granted rare pediatric disease designation to VG901, a gene therapy candidate targeting retinitis pigmentosa (RP) caused by mutations in the...
Xbrane Resubmits BLA to US FDA for Ranibizumab Biosimilar
Sweden’s Xbrane Biopharma announced Dec. 31 that it had resubmitted the biologics license application (BLA) to the US FDA for its Lucentis (ranibizumab) biosimilar candidate. The FDA issued a compl...
ViGeneron Gains US FDA Green Light to Begin Phase I/II Trial of Gene Therapy Candidate for Stargardt
Germany’s ViGeneron announced Dec. 18 that the US FDA had cleared its investigational new drug (IND) application for a Phase I/II study of VG801, a gene therapy candidate to treat Stargardt disease...
US FDA Grants Rare Pediatric Disease Designation to EyeDNA’s RP Gene Therapy Candidate
France’s eyeDNA Therapeutics announced Dec. 17 that the US FDA had granted rare pediatric disease designation for HORA-PDE6b, its gene therapy candidate for PDE6b-associated retinitis pigmentosa (R...
Glaukos Submits NDA for Epioxa Epi-On Crosslinking Treatment
Glaukos, of Aliso Viejo, California, reported Dec. 23 that it had submitted its new drug application to the US FDA for Epioxa, an epi-on version of the company’s iLink corneal crosslinking therapy,...
Alcon Recalls Single Lot of Systane Ultra PF Drops Over Fungal Contamination
The US FDA announced on Dec. 21 that Alcon was voluntarily recalling a single lot of Systane Lubricant Eye Drops Ultra PF over possible fungal contamination. Systane Ultra PF is used for the tempor...
US FDA Gives Green Light to Phase I/II Trial of SpliceBio’s Protein-Splicing Gene Therapy Candidate for Stargardt
Spain’s SpliceBio announced Dec. 12 that the US FDA had cleared its investigational new drug (IND) application for a Phase I/II trial of SB-007, a protein-splicing gene therapy candidate for Starga...
Roche’s Vabysmo Prefilled Syringe Approved in EU for Wet AMD, DME, and RVO
Swiss drugmaker Roche announced Dec. 13 that the European Medicines Agency had approved the Vabysmo (faricimab) 6.0 mg single-dose prefilled syringe for wet age-related macular degeneration (AMD), ...
Aflibercept Biosimilar Candidate from Celltrion Gains Positive CHMP Opinion
South Korea’s Celltrion announced Dec. 15 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had issued positive opinions recommending approval of three of i...
SIFI Files for UK Approval of Akantior Drops for Acanthamoeba Keratitis
Italy’s SIFI reported Dec. 16 that it had filed a marketing authorization application with the UK’s Medicines and Healthcare Products Regulatory Agency for Akantior (polihexanide 0.08%) drops for t...
Zeiss Gains US Approval for Next-Gen MEL 90 Excimer Laser
Carl Zeiss Meditec gained US FDA approval on Dec. 4 for its MEL 90 excimer laser, the next-generation iteration of its MEL 80 for LASIK surgery. The MEL 90’s US labeling is for correction of myopia...
Select US FDA Approvals and Clearances in November 2024
The US FDA granted one clearance through the ophthalmic device division using the 510(k) pathway in November 2024, according to the agency’s database. Novoxel, a newcomer to ophthalmology but not m...
PDUFA Dates for Ophthalmic Drug Candidates
The US FDA has scheduled the following Prescription Drug User Fee Act (PDUFA) target action dates for ophthalmic drug, drug/device, and biologic candidates.
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...
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...
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...
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...
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...
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...
December 2024 Ophthalmic News Briefs
Dutch company Ophtec announced Nov. 18 that it had gained CE marking for its Artiplus phakic IOL. The company said the lens offered a solution for relatively young presbyopes, typically in their ea...
US FDA Gives Green Light to Phase I/II Trial of Sumitomo Retinal Cell Implant for RP
Japan’s Sumitomo Pharma announced Nov. 29 that the US FDA had cleared its investigational new drug (IND) application for a Phase I/II trial of its allogeneic retinal sheet derived from induced plur...
US FDA Grants Orphan Drug Status to AAVantgarde Bio’s Gene Therapy Candidate for Usher1B RP
Italy’s AAVantgarde Bio announced Dec. 2 the US FDA had granted orphan drug designation to its lead gene therapy candidate, AAVB-081, targeting Usher syndrome type 1B retinitis pigmentosa. Orphan d...
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...
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...
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...
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...
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...
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 ...
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....
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...
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...
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...
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...
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...
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-...
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...
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...
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...
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 ...
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...
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...
Emerging Companies Pursuing Ophthalmic Indications, November 2024
Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.
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...
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...
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...
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...
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...
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) ...
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