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US FDA Rejects Eylea HD Prefilled Syringe over Inspection at Catalent Site
US FDA Rejects Eylea HD Prefilled Syringe over Inspection at Catalent Site

Regeneron reported in its Q3-2025 results on Oct. 28 that the US FDA had issued a complete response letter rejecting the supplemental biologics license application (sBLA) for a prefilled syringe of...

China Medical System Acquires Rights in China to Novartis’ Beovu and Lucentis
China Medical System Acquires Rights in China to Novartis’ Beovu and Lucentis

China Medical System Holdings of Hong Kong announced Oct. 27 that its ophthalmic subsidiary CMS Vision had acquired exclusive distribution rights in mainland China for Novartis’ retinal treatments ...

Amsurg Acquires ASC in South Carolina, Expanding Footprint in State
Amsurg Acquires ASC in South Carolina, Expanding Footprint in State

Amsurg, of Nashville, Tennessee, reported Oct. 28 that it had acquired Surgery Center of Conway, in Conway, South Carolina, its fourth center in the state. Amsurg, a leader in ambulatory surgery ce...

Viatris, Locus Biosciences to Collaborate on Ophthalmic Antibacterial Therapies
Viatris, Locus Biosciences to Collaborate on Ophthalmic Antibacterial Therapies

Viatris and Locus Biosciences announced on Oct. 28 a research collaboration to develop novel products targeting ophthalmic bacterial infections. No financial details about the collaboration were di...

VEO Ophthalmics Launches PeriVision’s VisionOne VR Visual Field Platform in US
VEO Ophthalmics Launches PeriVision’s VisionOne VR Visual Field Platform in US

VEO Ophthalmics announced Oct. 16 that the VisionOne VR Visual Field platform is now available in the US through a strategic partnership with Switzerland’s PeriVision. No financial details about th...

Alcon-STAAR Deal Up in the Air as Shareholder Vote is Delayed
Alcon-STAAR Deal Up in the Air as Shareholder Vote is Delayed

STAAR Surgical adjourned until Nov. 6 the shareholder vote for its planned sale to Alcon during a virtual special meeting of shareholders on Oct. 23. Alcon made public on Aug. 5 its plans to purcha...

US FDA Approves Glaukos’ Epioxa Epi-On Crosslinking Therapy for Keratoconus
US FDA Approves Glaukos’ Epioxa Epi-On Crosslinking Therapy for Keratoconus

Glaukos, of Aliso Viejo, California, reported Oct. 20 that the US FDA had approved Epioxa, an epi-on version of the company’s iLink corneal crosslinking therapy for keratoconus. Thomas Burns, Glauk...

J&J Vision Surgical Posts Q3-2025 Revenue of $383 Million
J&J Vision Surgical Posts Q3-2025 Revenue of $383 Million

J&J Vision’s Q3-2025 global surgical vision revenue totaled $383 million, a 14.9 percent increase over $333 million in Q3-2024, parent Johnson & Johnson, of New Brunswick, New Jersey, reported Oct....

2025 ESCRS Congress Boasts Strong Attendance and Multiple Product Launches
2025 ESCRS Congress Boasts Strong Attendance and Multiple Product Launches

More than 15 thousand people registered for the 2025 congress of the European Society of Cataract and Refractive Surgeons (ESCRS), held Sept. 12-16 at the Bella Center in Copenhagen, Denmark. Sixty...

Topcon Healthcare to Acquire AI Screening Company Toku
Topcon Healthcare to Acquire AI Screening Company Toku

Topcon Healthcare announced Oct. 17 that it had signed a definitive agreement to acquire Toku, an artificial intelligence (AI) health technology company originally founded in New Zealand. No financ...

Santen Acquires Rights in South Korea to Novartis’ Beovu and Lucentis
Santen Acquires Rights in South Korea to Novartis’ Beovu and Lucentis

Santen Pharmaceutical announced Oct. 20 that it had acquired exclusive distribution rights in South Korea for Novartis’ retinal treatments Beovu (brolucizumab) and Lucentis (ranibizumab). Both Beov...

AviadoBio Signs Option to License UgeneX’ Optogenetics Gene Therapy Candidate
AviadoBio Signs Option to License UgeneX’ Optogenetics Gene Therapy Candidate

UK-based AviadoBio announced Oct. 9 that it had signed an option agreement to license UGX-202, an AAV-based optogenetic treatment candidate targeting retinitis pigmentosa, from China’s UgeneX Thera...

US FDA Selects Abeona’s XLRS Candidate for Rare Disease Endpoint Program
US FDA Selects Abeona’s XLRS Candidate for Rare Disease Endpoint Program

Abeona Therapeutics announced Oct. 13 that the US FDA had selected its ABO-503 gene therapy candidate for X-linked retinoschisis (XLRS) to participate in the Rare Disease Endpoint Advancement (RDEA...

US FDA Grants Breakthrough Status to Nacuity’s Oral Candidate for RP
US FDA Grants Breakthrough Status to Nacuity’s Oral Candidate for RP

Nacuity Pharmaceuticals announced Oct. 2 that the US FDA had granted breakthrough therapy designation to NPI-001 (N-acetylcysteine amide) tablets, Nacuity’s oral treatment candidate for retinitis p...

US FDA Grants Orphan Drug Status to AAVantgarde’s Stargardt Candidate
US FDA Grants Orphan Drug Status to AAVantgarde’s Stargardt Candidate

Italy’s AAVantgarde Bio announced Oct. 2 that the US FDA had granted orphan drug status to AAVB-039, its gene therapy candidate for Stargardt disease. The candidate previously gained the FDA’s fast...

Verséa Ophthalmics Launches as Independent Company Named Defeye
Verséa Ophthalmics Launches as Independent Company Named Defeye

Verséa Ophthalmics announced Oct. 1 that it had launched as an independent company with the new name Defeye. It previously was a subsidiary of Verséa Health. Defeye, of Sarasota, Florida, has a por...

Valitor Appoints Gregory D. Kunst as Chief Executive Officer
Valitor Appoints Gregory D. Kunst as Chief Executive Officer

Valitor, of Berkeley, California, announced Oct. 17 that it had appointed Gregory D. Kunst as chief executive officer and a member of the board of directors. Kunst replaces interim CEO Michael Ostr...

ESCRS Roundtable Grapples with Impact of Cataract Surgery Waste
ESCRS Roundtable Grapples with Impact of Cataract Surgery Waste

The state of sustainability in cataract surgery was the focus of a roundtable of regulatory professionals and leading surgeons at the 2025 meeting of the Euro-pean Society of Cataract and Refractiv...

Eylea Biosimilars Pushing at Market Gates, Could Disrupt Pricing
Eylea Biosimilars Pushing at Market Gates, Could Disrupt Pricing

Aflibercept (Eylea) biosimilars are poised to have a significant impact on the exudative retinal disease pharmaceuticals market. The US saw its first Eylea biosimilar hit the market in Q4-2024, but...

Premium Cataract Surgery Growth Increasingly Led by International Markets
Premium Cataract Surgery Growth Increasingly Led by International Markets

International markets have disproportionately driven growth in the global premium cataract surgery (PCS) market since 2018. The market is expected to approach $3.2 billion in 2025, fueled by improv...

Alcon-STAAR Deal Up in the Air as Shareholder Vote is Delayed
Alcon-STAAR Deal Up in the Air as Shareholder Vote is Delayed

STAAR Surgical adjourned until Nov. 6 the shareholder vote for its planned sale to Alcon during a virtual special meeting of shareholders on Oct. 23. Alcon made public on Aug. 5 its plans to purcha...

Rayner Gains US FDA Approval of RayOne EMV Toric IOL
Rayner Gains US FDA Approval of RayOne EMV Toric IOL

UK-based Rayner announced Oct. 13 that the US FDA had approved its RayOne EMV Toric intraocular lens (IOL), and the lens is now available. Rayner CEO Tim Clover said: “The long-awaited FDA approval...

BVI’s FineVision HP Trifocal IOL Gains US FDA Approval; Rollout Set for 2026
BVI’s FineVision HP Trifocal IOL Gains US FDA Approval; Rollout Set for 2026

BVI Medical announced Oct. 14 that the US FDA had approved its FineVision HP trifocal intraocular lens (IOL). The company said the lens, the world’s first trifocal IOL, was backed by 15 years of cl...

US FDA Approves Glaukos’ Epioxa Epi-On Crosslinking Therapy for Keratoconus
US FDA Approves Glaukos’ Epioxa Epi-On Crosslinking Therapy for Keratoconus

Glaukos, of Aliso Viejo, California, reported Oct. 20 that the US FDA had approved Epioxa, an epi-on version of the company’s iLink corneal crosslinking therapy for keratoconus. Thomas Burns, Glauk...

Select US FDA Approvals and Clearances in September 2025
Select US FDA Approvals and Clearances in September 2025

The US FDA’s ophthalmic device division granted clearance to three devices using the 510(k) pathway in September 2025, according to the agency’s database. Medicel gained clearance for its Accuject ...

Iantrek Announces US Commercial Launch of AlloFlo Uveo Biostent
Iantrek Announces US Commercial Launch of AlloFlo Uveo Biostent

Iantrek announced Oct. 14 the US commercial launch of the AlloFlo Uveo, a novel minimally invasive glaucoma surgical (MIGS) device targeting the uveoscleral drainage pathway. The AlloFlo Uveo allog...

Retinal Pharma Deals Drive Ophthalmic Fundraising in Q3-2025
Retinal Pharma Deals Drive Ophthalmic Fundraising in Q3-2025

The retinal pharmaceuticals sector was the most active for ophthalmic deals in Q3-2025 and accounted for $503.1 million. Across all ophthalmic sectors, we identified 16 transactions totaling $716.1...

Ocular Tx Leads Latest Ophthalmic Fundraising with $475 Million Offering
Ocular Tx Leads Latest Ophthalmic Fundraising with $475 Million Offering

Ocular Therapeutix led recent ophthalmic fundraising efforts with a $475 million underwritten public offering to advance its Axpaxli IVT implant candidate for retinal disease. Financing announced i...

EssilorLuxottica Acquires Screening Software Company RetinAI
EssilorLuxottica Acquires Screening Software Company RetinAI

Eyewear conglomerate EssilorLuxottica announced Oct. 15 that it would acquire Swiss company Ikerian, operating under the RetinAI brand. RetinAI develops tools to collect, process, and grade large-s...

Nonexudative Retinal Pharmaceuticals Market Seeing Early Signs of Diversification
Nonexudative Retinal Pharmaceuticals Market Seeing Early Signs of Diversification

Positive signs of growth for nonexudative retinal pharmaceuticals indicate that the industry is putting Europe’s rejection of complement inhibition in 2024 behind it. Manufacturers of complement in...

Nova Eye’s iTrack Advance Canaloplasty Device Approved in China
Nova Eye’s iTrack Advance Canaloplasty Device Approved in China

Australia’s Nova Eye Medical announced Sept. 30 that China’s National Medical Products Administration had approved the marketing of the company’s iTrack Advance canaloplasty device for glaucoma. Th...

Attendees in Copenhagen Debate Whether Lasers Will Replace MIGS Stents
Attendees in Copenhagen Debate Whether Lasers Will Replace MIGS Stents

Panel sessions at the 2025 Ophthalmology Futures Forum and ESCRS Glaucoma Subspecialty Day brought together leading experts to debate the future of MIGS stents and whether lasers could emerge as a ...

2025-2027 Ophthalmic Meetings Calendar
2025-2027 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.

Digital Slit Lamp Technology Gains High Praise in Copenhagen
Digital Slit Lamp Technology Gains High Praise in Copenhagen

Slit lamps have remained largely unchanged for decades as optical-only devices that rely on physician drawings or written notes for documentation. Three innovations stood out at the 2025 Ophthalmol...

ESCRS Celebrates 30 Years of Femtosecond Lasers in Ophthalmology
ESCRS Celebrates 30 Years of Femtosecond Lasers in Ophthalmology

The European Society of Cataract and Refractive Surgeons paid tribute at its 2025 congress to the 30th anniversary of the first use of femtosecond lasers in ophthalmic surgery. Meeting organizers c...

Kala to Shut Down Eye Drop Program for Corneal Defect After Phase IIb Failure
Kala to Shut Down Eye Drop Program for Corneal Defect After Phase IIb Failure

Kala Bio reported Sept. 29 that it would cease development of lead asset KPI-012 and end its mesenchymal stem cell secretome program after the eye drop candidate failed to reach its primary endpoin...

Clinical Trial Updates for Ophthalmic Candidates, October 2025
Clinical Trial Updates for Ophthalmic Candidates, October 2025

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

PDUFA Dates for Ophthalmic Drug Candidates, October 2025
PDUFA Dates for Ophthalmic Drug Candidates, October 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.

Myopia Lenses from EssilorLuxottica Gain US FDA De Novo Marketing Authorization
Myopia Lenses from EssilorLuxottica Gain US FDA De Novo Marketing Authorization

Eyewear giant EssilorLuxottica and the US FDA announced Sept. 25 that the company’s Stellest spectacle lenses had gained de novo marketing authorization to slow the progression of myopia in childre...

Emerging Companies Pursuing Ophthalmic Indications, October 2025
Emerging Companies Pursuing Ophthalmic Indications, October 2025

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

Harrow Agrees to Reacquire Melt Pharmaceuticals
Harrow Agrees to Reacquire Melt Pharmaceuticals

Harrow, of Nashville, Tennessee, reported Sept. 26 that it had agreed to reacquire Melt Pharmaceuticals, a clinical stage company developing sedation and analgesia medicines for short-duration medi...

Weekly Surgeon Poll, October 2025
Weekly Surgeon Poll, October 2025

October 2025 Ophthalmic News Briefs
October 2025 Ophthalmic News Briefs

Biotech Healthcare announced Sept. 23 that it had launched the Optiflex Xtense Comfort Plus extended-depth-of-focus (EDOF) intraocular lens at the ESCRS 2025 congress in Copenhagen, Denmark. Biotec...

BVI Medical’s FineVision HP Trifocal IOL Gains US FDA Approval
BVI Medical’s FineVision HP Trifocal IOL Gains US FDA Approval

BVI Medical announced Oct. 14 that the US FDA had approved its FineVision HP trifocal intraocular lens (IOL). The company said the lens, the world’s first trifocal IOL, was backed by 15 years of cl...

Optos Launches the Silverstone RGB Advanced Retinal Imaging System
Optos Launches the Silverstone RGB Advanced Retinal Imaging System

UK-based Optos announced Oct. 15 that it had launched its next-generation Silverstone RGB system for retinal imaging. The device is designed to allowclinicians to capture, visualize, and analyze pa...

Iantrek Announces US Commercial Launch of AlloFlo Uveo Biostent for Glaucoma
Iantrek Announces US Commercial Launch of AlloFlo Uveo Biostent for Glaucoma

Iantrek announced Oct. 14 the US commercial launch of the AlloFlo Uveo, a novel minimally invasive glaucoma surgical (MIGS) device targeting the uveoscleral drainage pathway. The AlloFlo Uveo allog...

EssilorLuxottica Acquires Screening Software Company RetinAI
EssilorLuxottica Acquires Screening Software Company RetinAI

Eyewear conglomerate EssilorLuxottica announced Oct. 15 that it would acquire Swiss company Ikerian, operating under the RetinAI brand. RetinAI develops tools to collect, process, and grade large-s...

Epion Therapeutics Forms Strategic Partnership with Oculus
Epion Therapeutics Forms Strategic Partnership with Oculus

Epion Therapeutics announced Oct. 7 that it had entered a strategic partnership with Germany’s Oculus, maker of the Pentacam corneal tomographer. The partnership comes in conjunction with Epion clo...

Biotech Healthcare Launches Optiflex Xtense Comfort Plus EDOF IOL in Europe
Biotech Healthcare Launches Optiflex Xtense Comfort Plus EDOF IOL in Europe

Biotech Healthcare announced Sept. 23 that it had launched the Optiflex Xtense Comfort Plus extended-depth-of-focus (EDOF) intraocular lens at the ESCRS 2025 congress in Copenhagen, Denmark. Biotec...

OcuSciences’ OcuMet Beacon Retinal Imager Gains CE Marking
OcuSciences’ OcuMet Beacon Retinal Imager Gains CE Marking

OcuSciences, of Ann Arbor, Michigan, announced Oct. 15 that its OcuMet Beacon retinal imager had gained CE marking under the European Medical Device Regulation. The device gained US FDA 510(k) clea...

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