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.
Retina News
Alcon to Acquire LumiThera and Its Photobiomodulation Device for Dry AMD
Alcon announced July 7 that it intended to acquire LumiThera and its photobiomodulation (PBM) device that targets early and intermediate dry age-related macular degeneration (AMD). No financial det...
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...
Iridex Reports Start of UK Trial Using MicroPulse with Anti-VEGF Injections in DME
Iridex reported June 24 that an independent, investigator-led UK study evaluating MicroPulse technology as an adjunct to anti-VEGF therapy in diabetic macular edema (DME) had enrolled its first pat...
OpRegen’s Phase I/IIa Trial in GA Shows Mean Improvement in VA Through 36 Months
Lineage Cell Therapeutics reported on June 23 that patients with geographic atrophy who were treated with OpRegen cell therapy in a Phase I/IIa clinical study showed mean improvement in visual acui...
Donor Gives $40M to Ophthalmology Department at CU Anschutz in Colorado
An anonymous donor has given a $40 million gift for eye research to the Department of Ophthalmology at the University of Colorado (CU) AnschutzMedical Campus in Aurora, Colorado, the school announc...
Children’s Hospital Los Angeles Receives $12M Gift to Expand Cell, Gene Therapies
Children’s Hospital Los Angeles reported May 21 that it had received a $12 million gift from Alfred E. Mann Charities to establish a cell and gene therapy research endowment and a shorter-term fund...
Alcon Unity Cataract and Dual-Function Systems Gain Approval in Brazil
Alcon announced June 12 that its dual-function Unity Vitreoretinal Cataract System (VCS) and stand-alone Unity Cataract System (CS) had gained market approval from the Brazilian Health Regulatory A...
Zilia Gains Approval in Canada for its Fundus Camera With Ocular Oximetry
Quebec-based device maker Ziliareported June 19 that its Zilia Ocular device, a fundus camera that enables ocular oximetry, had gained approval from Health Canada. The company said it plans to laun...
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...
ARVO Sets Tone for AI-Focused Week With Avatar at Keynote Speech
The 2025 meeting of the Association for Research in Vision and Ophthalmology (ARVO) exceeded atten-dance expectations despite uncertainties sparked by US funding restrictions. The 10,915 attendees ...
Ophthalmic Company Revenue in Q1-2025 Down 2.1 Percent as Multiple Firms Report Declines
Ophthalmic manufacturer revenue in Q1-2025 totaled $11.0 billion. Revenue decreased 2.1 percent from the same quarter in 2024 and decreased 8.1 percent from Q4-2024. The total includes Market Scope...
Ophthalmologists Report 3.0 Percent Decrease in Q1-2025 Procedure Volume
US ophthalmologists reported that ophthalmic procedures decreased 3.0 percent in Q1-2025 compared with the same quarter in 2024, according to Market Scope’s latest survey. Year-over-year performanc...
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...
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...
Regenxbio Leads Latest Ophthalmic Fundraising with $150 Million Royalty Sale
Regenxbio led recent ophthalmic fundraising efforts with a $150 million sale of future non-ophthalmic royalties to Healthcare Royalty (HCRx). Financing announced in the past four weeks totaled $535...
Gore Launches Silicone-Free Plunger for Ophthalmic Prefilled Syringes
Materials company W.L. Gore & Associates announced June 3 the commercial launch of its 0.5 mL silicone-free Improject syringe plunger. The new plunger is specifically designed for prefilled syringe...
2025-2026 Ophthalmic Meetings Calendar
Market Scope regularly updates its list of ophthalmic meetings to keep the information current. Please contact us at matthewdouty@market-scope.com if we do not have your meeting listed. Thank you.
ARVO Showcases Manufacturers Looking to Refine Ocular Injections
Big ideas typically dominate the headlines, such as AI, gene therapy, or oculomics, but innovation also happens in small things. The 2025 ARVO meeting displayed a surprising amount of attention to ...
Batten Disease Candidate Leads the Way in New Gene Therapy Trials
A presentation by Robert Henderson, MD (UK), on May 8 was a highlight of the many ARVO sessions on gene therapy. Henderson presented interim results from a clinical trial of a gene therapy candidat...
Innovation and Collaboration Take Center Stage at Eyecelerator Meeting
For the first time, an Eyecelerator meeting preceded the ARVO annual conference, convening on May 2 at the Grand Hyatt Deer Valley in Park City, Utah. The event brought together 363 attendees, incl...
Clinical Trial Updates for Ophthalmic Candidates, June 2025
Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.
Emerging Companies Pursuing Ophthalmic Indications, June 2025
Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.
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.
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...
NIH Study Determines Brain Circuits Affected by Retinal Cell Loss
Researchers at the National Institutes of Health have determined which vision-processing cells in the brain are affected by damaged retinal ganglion cells (RGCs). Current vision restoration therapi...
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...
Beacon Therapeutics Appoints Daniel Chung, DO, as Chief Medical Officer
Beacon Therapeutics announced June 9 that it had appointed Daniel Chung, DO, as chief medical officer. Chung most recently served as chief medical officer of the ophthalmic gene therapy company Spa...
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...
Outlook Launches Lytenava (Bevacizumab) in Germany, UK for Wet AMD
Outlook Therapeutics announced June 2 that it had launched Lytenava (bevacizumab gamma) in Germany and the UK for the treatment of wet age-related macular degeneration (AMD). The company said it wa...
Gore Launches Silicone-Free Plunger for Ophthalmic Prefilled Syringes
Materials company W.L. Gore & Associates announced June 3 the commercial launch of its 0.5 mL silicone-free Improject syringe plunger. The new plunger is specifically designed for prefilled syringe...
Bayer Receives Approval in China for High-Dose Eylea in Wet AMD
German drugmaker Bayer announced May 22 that China’s National Medical Products Administration had granted marketing authorization for high-dose Eylea (aflibercept 8 mg) for the treatment of wet age...
New Scleral Clamp Allows Delivery of Two Cell Grafts in Same Eye for Comparing Effects
Scientists with the National Institutes of Health have shown that a new surgical technique can successfully deliver two cell grafts in adjacent subretinal locations in the same eye—allowing direct ...
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...
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...
Dyno Launches New Capsid for Ophthalmic Gene Therapy Developers
Dyno Therapeutics, of Watertown, Massachusetts, has launched a new adeno-associated virus (AAV) capsid for ophthalmic gene therapies, in addition to capsids for neuromuscular and central nervous sy...
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, ...
Regenxbio Moves to Monetize Future Royalties in Deal Worth up to $250 Million
Gene therapy developer Regenxbio announced May 19 that it had closed a non-dilutive royalty bond agreement worth up to $250 million with Healthcare Royalty (HCRx). The Rockville, Maryland, company ...
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 ...
Topcon Healthcare Acquires RetInSight to Advance AI-Powered Imaging in Eye Care
Topcon Healthcare announced May 2 that it had acquired privately held retinal AI analysis company RetInSight, of Austria. No financial details were disclosed. The companies forged a partnership in ...
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 ...
Therini Bio Leads Latest Ophthalmic Fundraising with $39 Million in Series A
Therini Bio led recent ophthalmic fundraising efforts with $39 million in Series A funding to advance its lead candidate targeting the inflammatory component of fibrin. Financing announced in the p...
GA Patients in Eyestem Cell Therapy Trial Show Significant Improvement
India’s Eyestem Research reported April 15 that patients with geographic atrophy (GA) in a Phase I trial of its Eyecyte-RPE cell therapy saw significant vision improvement. Eyecyte-RPE is a cryopre...
Alcon Emphasizes Efficiency of Unity VCS and CS Systems at ASCRS Launch
Surgeons attending the 2025 ASCRS meeting in Los Angeles dropped by Alcon’s booth for multiple presentations of the new Unity dual-function and cataract machines, rather than gathering in big numbe...
Unity Bio to Cut Workforce, Seek Strategic Alternatives for UBX1325 in Retina
Unity Biotechnology announced May 5 that it would reduce its workforce and seek an established ophthalmic company to continue the development of intravitreal UBX1325, a Tie2/anti-VEGF bispecific an...
Clinical Trial Updates for Ophthalmic Candidates, May 2025
Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.
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...
Emerging Companies Pursuing Ophthalmic Indications, May 2025
Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.
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...
Q1-2025 Ophthalmic Revenue Roundup for Alcon, Immunocore, Harrow, Sight Sciences, ANI, Iridex, and Xbrane
Alcon reported May 13 that its Q1-2025 net sales were $2.45 billion, on par with $2.44 billion in Q1-2024 and up 3 percent on a constant currency basis. Surgical net sales totaled $1.33 billion (do...
Unity Bio to Cut Workforce, Seek Strategic Alternatives for UBX1325 in Retina
Unity Biotechnology announced May 5 that it would reduce its workforce and seek an established ophthalmic company to continue the development of UBX1325, a Tie2/anti-VEGF bispecific antibody candid...
Maximilian Foerst to Lead Carl Zeiss Meditec, as Markus Weber, PhD, Steps Down
Carl Zeiss Meditec announced May 7 that Markus Weber, PhD, the company’s president and CEO, will step down of his own accord, effective May 31. Replacing Weber will be Maximilian Foerst, currently ...
Topcon Healthcare Acquires RetInSight to Advance AI-Powered Imaging in Eye Care
Topcon Healthcare announced May 2 that it had acquired privately held retinal AI analysis company RetInSight, of Austria. No financial details were disclosed. The companies forged a partnership in ...
Q1-2025 Ophthalmic Revenue Roundup for Amgen, Hoya, Apellis, Tarsus, STAAR, RxSight, and Ocular Therapeutix
Amgen, of Thousand Oaks, California, reported May 1 that its Q1-2025 revenue from Tepezza was $381 million, a 10 percent decrease from $424 million in Q1-2024. The total consisted of $365 million...
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...
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...
Q1-2025 Ophthalmic Revenue Roundup for Roche, Regeneron, AbbVie, Glaukos, Lumibird, and Biogen
Swiss company Roche reported April 24 that Vabysmo sales in Q1-2025 were CHF 1 billion ($1.1 billion, calculated March 31, 2025), up 18 percent in constant currency from CHF 847 million in Q1-2024....
GA Patients in Eyestem Phase I Cell Therapy Trial Show Significant Vision Improvement
India’s Eyestem Research reported April 15 that patients with geographic atrophy (GA) in a Phase I trial of its Eyecyte-RPE cell therapy saw significant vision improvement. Eyecyte-RPE is a cryopre...
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...
Alcon Rolls Out Unity VCS and CS Systems at ASCRS Meeting
Alcon announced April 25 the launch of its dual-function Unity Vitreoretinal Cataract System (VCS) and stand-alone Unity Cataract System (CS) in four markets, including the US. The announcement cam...
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...
May 12 is Deadline to Apply for Ramin Tadayoni Award for Research
Applications are open until May 12, 2025, for this year’s Ramin Tadayoni Award, offered by the European Society of Retina Specialists, or Euretina, and supported by Oculis as a tribute to retina sp...
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...
Retina Pharma and Premium IOLs Continue to Drive Ophthalmic Market
The ophthalmology industry produced an estimated $48.8 billion in revenue in 2024, with an expected compound annual growth rate (CAGR) of 4.5 percent. Market Scope estimates the industry will reach...
Opthea Discontinues Wet AMD Program After Second Phase III Trial Misses Endpoint
Opthea announced March 31 its decision to discontinue development of sozinibercept (OPT-302) in wet age-related macular degeneration (AMD) after a second Phase III trial missed its primary endpoint...
Clinical Trial Updates for Ophthalmic Candidates, April 2025
Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.
Emerging Companies Pursuing Ophthalmic Indications, April 2025
Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.
Biocon’s Deal with Regeneron Will Bring Yesafili to Market in US No Later than H2-2026
India’s Biocon Biologics reported April 15 that it had reached a settlement and license agreement with Regeneron that clears the way for Biocon to commercialize Yesafili, a biosimilar to Eylea, in ...
Thomas Panek Becomes President, CEO of Lighthouse Guild
Lighthouse Guild announced March 18 that it had appointed Thomas Panek as its new president and CEO, effective April 1. Panek replaced Calvin Roberts, MD, who had led the nonprofit since April 2020...
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...
Biocon Reaches Settlement, License Agreement with Regeneron to Bring Yesafili to Market in US
India’s Biocon Biologics reported April 15 that it had reached a settlement and license agreement with Regeneron that clears the way for Biocon to commercialize Yesafili, a biosimilar to Eylea, in ...
Opthea Will Lay Off 65 Percent of Employees after Phase III Wet AMD Failures
Opthea plans to lay off about 65 percent of its workforce, effective May 1, the company said in a corporate update filed April 10 with the with the US Securities and Exchange Commission (SEC). The ...
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...
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...
Opthea Discontinues Wet AMD Trials After Second Phase III Trial Misses Endpoint
Opthea announced March 31 its decision to discontinue development of sozinibercept (OPT-302) in wet age-related macular degeneration (AMD) after a second Phase III trial missed its primary endpoint...
2024 Ophthalmic Revenue Roundup for Harrow, Astellas, Iridex, and Xbrane
Nashville, Tennessee-based Harrow reported March 27 that its 2024 revenue was $199.6 million, a 53 percent increase over $130.2 million in 2023. The company generated record quarterly revenue in Q4...
Aviceda Appoints Jeffrey Nau, PhD, MMS, as Chief Executive Officer
Aviceda Therapeutics announced April 1 that it had appointed Jeffrey Nau, PhD, MMS, as chief executive officer, effective immediately. Nau will also join the company’s board of directors, Aviceda s...
Opthea, Unity Candidates Miss Clinical Trial Endpoints vs. Aflibercept
Opthea and Unity Biotechnology reported results March 24 for their retinal treatment candidates that failed to meet or beat Regeneron’s Eylea (aflibercept) in clinical trials for wet AMD and DME, r...
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...
Surrozen to Focus on Ophthalmic Pipeline, Raises up to $175 Million in Private Placement
Surrozen announced March 24 that it would focus on its ophthalmic pipeline, including the development of new treatment options for retinopathies. Concurrently, the company said that a private place...
Zeiss Launches Visulas Combi in Canada
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 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...
Thomas Panek to Lead Lighthouse Guild
Lighthouse Guild announced March 18 that it had appointed Thomas Panek as its new president and CEO, effective April 1. Panek replaces Calvin Roberts, MD, who has led the nonprofit since April 2020...
Xbrane to Sell Part of Company to Alvotech, Plans to Keep Ximluci
Sweden’s Xbrane will sell its Cimzia biosimilar candidate and parts of its organization to Iceland’s Alvotech for SEK 275 million ($27.1 million), the two companies reported March 20. Xbrane will r...
Vivani Now Intends to Spin Out Cortigent, Developer of Orion Implant
Vivani Medical, of Alameda, California, reported March 12 that it intends to spin off its Cortigent neurostimulation business, formerly Second Sight Medical Products, into a fully independent, publ...
Astellas, MBC BioLabs Offer Sixth Future Innovator Prize
Japan’s Astellas Pharma is again collaborating with MBC BioLabs, a launchpad for early-stage life-science companies, to offer the sixth Astellas Future Innovator Prize. The competition offers up to...
Ophthalmologists Report 5.3 Percent Increase in Q4-2024 Procedure Volume
US ophthalmologists reported that ophthalmic procedures increased 5.3 percent in Q4-2024 compared with the same quarter in 2023, according to Market Scope’s latest survey. Year-over-year performanc...
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...
Retina Surgeons Ready for Alcon to Make a Splash with Unity VCS
Alcon looks ready to shake up the retinal treatment device market with the launch of the Unity VCS later in 2025. Anytime the world’s number one manufacturer of vitreoretinal surgical systems intro...
Clinical Trial Updates for Ophthalmic Candidates, March 2025
Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.
Early Study Shows Promise for Head-Mounted Retinal Surgery Robot
Researchers at the University of Utah’s John A. Moran Eye Center and John and Marcia Price College of Engineering reported Feb. 19 that they have collaborated to create a new robotic surgery device...
Emerging Companies Pursuing Ophthalmic Indications, March 2025
Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.
BVI Leads Latest Ophthalmic Fundraising with $1 Billion in Strategic Capital
BVI Medical led recent ophthalmic fundraising efforts with $1 billion in strategic capital, raised from owner TPG and new investors, to continue expanding globally. Financing announced in the past ...
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...
2024 Ophthalmic Revenue Roundup for Amgen and Biogen
Amgen, of Thousand Oaks, California, reported Feb. 4 that its 2024 revenue for Tepezza was $1.85 billion. 2024 was the first full year of Tepezza sales for Amgen after the company closed its acquis...
Early Study Shows Promise for Head-Mounted Retinal Surgery Robot
Researchers at the University of Utah’s John A. Moran Eye Center and John and Marcia Price College of Engineering reported Feb. 19 that they have collaborated to create a new robotic surgery device...
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...
2024 Ophthalmic Revenue Roundup for Apellis, Immunocore, Sight Sciences, Ocular Therapeutix, Lensar, and ANI
Apellis Pharmaceuticals, of Waltham, Massachusetts, reported Feb. 28 that its 2024 net product revenue for Syfovre was $611.8 million, a 122.3 percent increase over $275.2 million in 2023. The comp...
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...
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...
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...
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...
Norlase Strengthens Position in Ophthalmic Laser Market with Launch of Lynx LIO
Norlase strengthened its position in the ophthalmic laser market on Jan. 22 when it launched Lynx, the world’s first pattern scanning laser indirect ophthalmoscope (LIO). The Lynx laser and pattern...
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...
EssilorLuxottica Acquires Canadian Retinal Camera Maker Cellview Imaging for Undisclosed Amount
Eyewear conglomerate EssilorLuxottica announced Feb. 11 that it had acquired Cellview Imaging, a Canadian startup specializing in ultra-widefield retinal diagnostics. Cellview’s WRI-1 fundus camera...
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 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...
Oculis Leads Latest Ophthalmic Fundraising with $100 Million Offering
Oculis led recent ophthalmic fundraising efforts with an underwritten $100 million offering to advance its pipeline of ocular candidates. Financing announced in the past four weeks totaled $149.1 m...
Harrow, Cencora Partner to Improve Drug Access for Retina Specialists, Patients
Drugmaker Harrow reported Jan. 27 that it had partnered with Cencora to launch a program called “Harrow Cares,” with the goal of making Harrow products iHeezo and Triesence more accessible and affo...
Clinical Trial Updates for Ophthalmic Candidates, February 2025
Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.
Retrospective Study Finds Link Between IVT Injections, Cataract Surgery Complications
Researchers from the Byers Eye Institute at Stanford Health Care in Palo Alto, California, have found that cataract patients with prior intravitreal (IVT) injections face more complications after c...
Study Shows Promise for Genetic Base Editing in Stargardt Disease
Researchers from Switzerland’s Institute of Molecular and Clinical Ophthalmology Basel and Beam Therapeutics say they have developed a gene editing therapy that could potentially treat Stargardt di...
Emerging Companies Pursuing Ophthalmic Indications, February 2025
Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.
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...
2024 and Quarterly Ophthalmic Revenue Roundup for Regeneron, Carl Zeiss Meditec, Hoya, and STAAR
Regeneron, of Tarrytown, New York, reported Feb. 4 that its 2024 US revenue for Eylea 2 mg (aflibercept 2 mg) and Eylea HD (aflibercept 8 mg) totaled nearly $5.97 billion, a 1 percent increase over...
EssilorLuxottica Acquires Canadian Retinal Camera Maker Cellview Imaging
Eyewear conglomerate EssilorLuxottica announced Feb. 11 that it had acquired Cellview Imaging, a Canadian startup specializing in ultra-widefield retinal diagnostics. Cellview’s WRI-1 fundus camera...
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...
2024 Ophthalmic Revenue Roundup for Roche, AbbVie, Novartis
Swiss company Roche reported Jan. 29 that global sales of Vabysmo for 2024 were CHF 3.86 billion ($4.25 billion, converted Jan. 29, 2025), a 63.6 percent increase (+68 percent cc) over CHF 2.36 bil...
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...
Harrow, Cencora Partner to Improve Drug Access for Retina Specialists, Patients
Drugmaker Harrow reported Jan. 27 that it had partnered with Cencora to launch a program called “Harrow Cares,” with the goal of making Harrow products iHeezo and Triesence more accessible and affo...
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 ...
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...
Retrospective Study Finds Link Between IVT Injections, Cataract Surgery Complications
Researchers from the Byers Eye Institute at Stanford Health Care in Palo Alto, California, have found that cataractpatients with prior intravitreal (IVT) injections face more complications after ca...
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...
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...
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 ...
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.
Aviceda Leads Latest Ophthalmic Fundraising with $207.5 Million Round
Aviceda Therapeutics led recent ophthalmic fundraising efforts with an upsized $207.5 million Series C financing round to support its trials in geographic atrophy. Financing announced in the past f...
2024 in Review: Corporate and Surgeon Rankings of Top 10 Stories
Market Scope asked industry participants and surgeons to select the top story for 2024. Below are their choices. Zeiss’ Rollout of Micor 700 Shakes Up Cataract Equipment Market in US MAC Turmoil Sh...
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: Flurry of Eylea Biosimilars Approved; Most Blocked in US by Lawsuits
The FDA was in a hurry in 2024 to get low-cost competitors to Eylea into the US market. Regeneron wasn’t. The FDA approved 12 drugs for ophthalmic indications in 2024, including four generic glauco...
2024 in Review: Complement Therapies for GA Fall Short in Bid for Approval in EU
Apellis Pharmaceuticals and Astellas Pharma were unable to build on their regulatory wins in the US to get a victory in Europe. The European Medicines Agency’s Committee for Medicinal Products for ...
Clinical Trial Updates for Ophthalmic Candidates, January 2025
Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.
EssilorLuxottica to Acquire Ophthalmic Device Maker Espansione Group
Eyewear conglomerate EssilorLuxottica announced Dec. 16 that it had entered into an agreement to acquire Espansione Group, an Italian maker of light-based ophthalmic devices. Financial details and ...
Children’s Hospital Los Angeles Celebrates 100th Luxturna Procedure
Children’s Hospital Los Angeles (CHLA) marked a milestone recently, completing its 100th procedure with the retinal gene therapy Luxturna for Leber congenital amaurosis (LCA)—the most of any center...
Emerging Companies Pursuing Ophthalmic Indications, January 2025
Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.
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...
Bausch + Lomb Moves to Acquire Whitecap, InflammX to Expand Clinical Pipeline
Bausch + Lomb recently made moves to acquire two companies that it says will strengthen its expanding pipeline and help address unmet needs in ophthalmology. The company announced Jan. 13 that an a...
Dual Inflammasome Inhibiting Implant Shows Positive Phase I/II Results in GA
Inflammasome Therapeutics reported on Jan. 15 positive topline three-month data from a Phase I/II trial of its K8 dual inflammasome inhibiting implant in geographic atrophy (GA). In the study of fi...
Study Shows Promise for Genetic Base Editing in Stargardt Disease
Researchers from Switzerland’s Institute of Molecular and Clinical Ophthalmology Basel and Beam Therapeutics say they have developed a gene editing therapy that could potentially treat Stargardt di...
Bausch + Lomb to Collaborate with Character Bio, City Therapeutics in AMD, GA
Bausch + Lomb recently made deals to collaborate with two companies that it says will bolster its expanding pipeline and help address unmet needs in ophthalmology. Character Biosciences reported on...
Teva Signs Deal to Commercialize Formycon’s Aflibercept Biosimilar Candidate in Israel and Most of Europe
Israel’s Teva Pharmaceuticals announced Jan. 13 that it had entered into a collaboration with German companies Klinge Biopharma and Formycon for the semi-exclusive commercialization of FYB203, Form...
Valo Health Suspends Work on Oral DR Candidate After Phase II Trial Misses Endpoints
Valo Health reported Dec. 31 that OPL-0401, its oral diabetic retinopathy treatment candidate, missed its primary and secondary endpoints of improvement in Diabetic Retinopathy Severity Scale score...
Aviceda Raises $207.5 Million in Upsized Series C Round to Advance GA Candidate
Aviceda Therapeutics announced Jan. 7 that it had raised $207.5 million in an upsized Series C funding round. The Cambridge, Massachusetts, company said proceeds would support an ongoing Phase IIb/...
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...
Eyenuk Appoints Gaurav Agarwal as Chief Executive Officer
Digital health care company Eyenuk, of Los Angeles, California, announced Jan. 6 that it had appointed Gaurav Agarwal as chief executive officer. Agarwal was previously the head of product and cust...
Unity Biotechnology Appoints Federico Grossi, MD, PhD, as Chief Medical Officer
Unity Biotechnology announced Jan. 6 that it had appointed Federico Grossi, MD, PhD, as chief medical officer. Grossi was most recently chief medical officer at Apellis Pharmaceuticals, where he he...
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...
Ophthalmic Revenue Roundup for Carl Zeiss Meditec, Amgen, Biogen
Carl Zeiss Meditec reported Dec. 11 that ophthalmology revenue for its full fiscal year 2023/2024, which ended Sept. 30, was €1.59 billion (US $1.7 billion, converted Dec. 11, 2024), an increase of...
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...
EssilorLuxottica to Acquire Espansione Group, Maker of Ophthalmic Devices
Eyewear conglomerate EssilorLuxottica announced Dec. 16 that it had entered into an agreement to acquire Espansione Group, an Italian maker of light-based ophthalmic devices. Financial details and ...
SightStream is Developing an Eye Drop Candidate for Corneal Endothelial Disease
SightStream Biotherapeutics, an ophthalmic drug development company spun out of Harvard University in 2020, is raising $7.5 million in Series A funding to advance its preclinical melanocortin recep...
Children’s Hospital Los Angeles Celebrates 100th Luxturna Procedure
Children’s Hospital Los Angeles (CHLA) marked a milestone recently, completing its 100th procedure with the retinal gene therapy Luxturna for Leber congenital amaurosis (LCA)—the most of any center...
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...
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), ...
NIH Joins Push to Fund Breakthroughs in Oculomics
The National Institutes of Health (NIH) is joining the push to fund the development of technologies and biomarkers to diagnose systemic disease through the eye, a field known as oculomics. The NIH ...
$2.3 Million NIH Grant Furthers U. of Oklahoma Research into Retinopathy of Prematurity
A University of Oklahoma neonatologist has earned a five-year, $2.3 million grant from the National Institutes of Health (NIH) to further her studies on retinopathy of prematurity (ROP). Faizah Bha...
Scripps Research Includes AMD Among its Regenerative Medicine Targets
Scientists at Scripps Research and its nonprofit drug development arm, the Calibr-Skaggs Institute for Innovative Medicines, are advancing novel regenerative medicines capable of repairing tissues ...
Acelyrin’s Izokibep Misses Endpoints in Phase IIb/III Uveitis Trial
Acelyrin reported Dec. 10 that izokibep, an inhibitor of interleukin-17A, missed its endpoints in a Phase IIb/III trial in non-infectious, non-anterior uveitis. The company said it would drop izoki...
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...
Ophthalmologists Report 5.5 Percent Increase in Q3-2024 Procedure Volume
US ophthalmologists reported that ophthalmic procedures increased 5.5 percent in Q3-2024 compared with the same quarter in 2023, according to Market Scope’s latest survey. Year-over-year performanc...
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.
NIH Joins Push to Fund Breakthroughs in Oculomics Diagnostic Tech
The National Institutes of Health (NIH) is joining the push to fund the development of technologies and biomarkers to diagnose systemic disease through the eye, a field known as oculomics. The NIH ...
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...
Arctic Vision Licenses Chinese Rights for Xipere to Santen for $85 Million
Clearside Biomedical’s Asia-Pacific partner, Arctic Vision, announced Nov. 7 that it had licensed Chinese commercialization rights for ARVN001, marketed in the US as Xipere, to Santen Pharmaceutica...
Clinical Trial Updates for Ophthalmic Candidates, December 2024
Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.
Lineage Leads Latest Ophthalmic Fundraising with $66 Million Offering
Lineage Cell Therapeutics led recent ophthalmic fundraising efforts with a registered direct offering worth up to $66 million to advance its RPE cell therapy candidate. Financing announced in the p...
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...
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...
Emerging Companies Pursuing Ophthalmic Indications, December 2024
Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.
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...
Kyung-Ah Kim, PhD, Named President, CEO of Samsung Bioepis
South Korea’s Samsung Bioepis announced Nov. 27 that Kyung-Ah Kim, PhD, has been appointed president and chief executive officer. Kim had been serving as executive vice president and development di...
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...
Avant, Ainnova Advancing Low-Cost Retinal Camera with AI Screening Software
Nevada-based Avant Technologies and Ainnova Tech, of Houston, Texas, announced Nov. 20 that the two companies would advance Ainnova’s proprietary low-cost retinal camera packaged with the Vision AI...
Want to Read the Full Article?
Already Have an Account?
Register A Corporate Account
A corporate account gives you access to licensed reports and subscriptions, the latest news, a personalized dashboard, and weekly emails with news and data.