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Recently Added News

8/29/2025
BreakingPharmaRegulationRetina
US FDA Again Rejects Outlook’s Lytenava for Wet AMD, Citing Lack of Efficacy Evidence
US FDA Again Rejects Outlook’s Lytenava for Wet AMD, Citing Lack of Efficacy Evidence

Outlook Therapeutics reported Aug. 28 that the US FDA had issued a complete response letter rejecting the company’s resubmitted biologics license application (BLA) for Lytenava, an ophthalmic formu...

8/29/2025
BreakingEuropeGlaucomaMIGSRegulationSurgical
Ciliatech’s Intercil Uveal Spacer for Glaucoma Gains CE Marking
Ciliatech’s Intercil Uveal Spacer for Glaucoma Gains CE Marking

France’s Ciliatech announced Aug. 27 that European regulators had granted CE marking for the Intercil Uveal Spacer, a surgical implant for glaucoma. The Intercil, also known as the cilioscleral int...

8/29/2025
BreakingFundingOptometryRefractive
Eyebot to Expand Self-Serve Vision-Testing Kiosks with $20 Million Financing
Eyebot to Expand Self-Serve Vision-Testing Kiosks with $20 Million Financing

Eyebot, of Boston, Massachusetts, plans to use the $20 million it raised in a Series A round in August 2025 to expand its vision testing kiosks to new retail locations. The kiosks—located in malls,...

8/29/2025
BiosimilarsBreakingDiagnosticDry EyeLaserMyopiaRetinaRevenue
Quarterly Ophthalmic Revenue Roundup for Santen, Lumibird, Biogen, and Xbrane
Quarterly Ophthalmic Revenue Roundup for Santen, Lumibird, Biogen, and Xbrane

Japan’s Santen Pharmaceutical reported Aug. 7 that its revenue for the quarter ended June 30, 2025, the first quarter of its fiscal year, was ¥68.7 billion ($475.6 million, converted on June 30, 20...

8/29/2025
BreakingPharmaRegulationRetina
Manufacturer Inspection Report Delays Two Eylea HD Target Action Dates 
Manufacturer Inspection Report Delays Two Eylea HD Target Action Dates

Regeneron announced Aug. 20 that the US FDA had extended the target action dates to Q4-2025 for two Eylea HD (aflibercept 8 mg) submissions. Reports from a recent inspection of a third-party manufa...

8/29/2025
BreakingFundingGlaucomaStudy
Glaucoma Research Foundation to Use $5 Million Gift to Create Accelerator
Glaucoma Research Foundation to Use $5 Million Gift to Create Accelerator

The Glaucoma Research Foundation reported Aug. 20 that it plans to use a $5 million gift from the John and Daria Barry Foundation—the largest single donation in the foundation’s history—to launch t...

8/29/2025
BreakingRegulationRetina
US FDA Grants Fast Track Status to Aldeyra’s ADX‑2191 (Methotrexate) for RP
US FDA Grants Fast Track Status to Aldeyra’s ADX‑2191 (Methotrexate) for RP

Aldeyra Therapeutics announced Aug. 19 that the US FDA had granted its fast track designation to ADX‑2191 (methotrexate intravitreal injection) for retinitis pigmentosa (RP). The candidate also has...

8/29/2025
BreakingGene TherapyRegulationRetina
US FDA Grants RMAT Status to VeonGen’s Gene Therapy Candidate in Stargardt
US FDA Grants RMAT Status to VeonGen’s Gene Therapy Candidate in Stargardt

Germany’s VeonGen Therapeutics announced Aug. 21 that the US FDA had granted regenerative medicine advanced therapy (RMAT) designation to VG801, its gene therapy candidate for Stargardt disease and...

8/22/2025
BiosimilarsBreakingEuropeRegulationRetina
Alvotech, Advanz Gain EU Approval for Eylea Biosimilar Under Brand Name Mynzepli
Alvotech, Advanz Gain EU Approval for Eylea Biosimilar Under Brand Name Mynzepli

Alvotech and partner Advanz Pharma announced Aug. 21 that the European Commission had granted marketing authorization for their Eylea (aflibercept 2 mg) biosimilar under the brand name Mynzepli. Th...

8/22/2025
BreakingCataractDealsDiagnosticIndustryPharmaPresbyopiaRetinaRevenueSurgical
Q2-2025 Ophthalmic Revenue Roundup for Alcon, Carl Zeiss Meditec, Opus, and Outlook
Q2-2025 Ophthalmic Revenue Roundup for Alcon, Carl Zeiss Meditec, Opus, and Outlook

Alcon reported Aug. 19 that its Q2-2025 net sales totaled $2.6 billion, a 4 percent increase (+3 percent cc) over $2.5 billion in Q2-2024. Surgical net sales for implantables, consumables, and equi...

8/22/2025
BreakingCornealRefractiveStudy
Researchers See Early Promise in Electromechanical Reshaping of Cornea
Researchers See Early Promise in Electromechanical Reshaping of Cornea

Researchers in California are exploring the possibility of electromechanical reshaping of the cornea for laser-free refractive surgery. Michael Hill, a professor of chemistry at Occidental College,...

8/20/2025
MeetingNewsletterRetinaSurgical
ASRS Meeting Returns Surgery to the Forefront of Discussion
ASRS Meeting Returns Surgery to the Forefront of Discussion

Guarav Shah, MD, program chair for the 2025 annual meeting of the American Society of Retina Specialists (ASRS), opened the conference with an important announcement. “We have to recalibrate what w...

Past News Stories

8/22/2025
BreakingMeeting
Philippine Academy of Ophthalmology Warns of Fake Website for Congress
Philippine Academy of Ophthalmology Warns of Fake Website for Congress

The Philippine Academy of Ophthalmology (PAO) issued a warning to the ophthalmic community on Aug. 21 of a fake website representing the group’s upcoming meeting. The fraudulent website encouraged ...

8/22/2025
BreakingDealsPharmaRetina
Boehringer Ingelheim, Palatin to Collaborate on Melanocortin Agonist for Retina
Boehringer Ingelheim, Palatin to Collaborate on Melanocortin Agonist for Retina

Boehringer Ingelheim and Palatin Technologies will collaborate to develop a therapy for retinal diseases in a deal worth up to $320 million for Palatin, the companies announced Aug. 18. Palatin’s p...

8/22/2025
BreakingChinaDealsPharmaRetina
Santen Licenses RemeGen’s Retinal Candidate for Greater China, Asian Countries
Santen Licenses RemeGen’s Retinal Candidate for Greater China, Asian Countries

RemeGen announced Aug. 18 that Santen China, a subsidiary of Japan’s Santen Pharmaceutical, had licensed retinal treatment candidate RC28-E for Greater China and certain other Asian countries. Reme...

8/22/2025
BreakingClinical TrialGene TherapyRegulationRetina
US FDA Gives Green Light to Phase I/II Trial of Opus’ BEST1 Gene Therapy Candidate
US FDA Gives Green Light to Phase I/II Trial of Opus’ BEST1 Gene Therapy Candidate

Opus Genetics announced Aug. 18 that the US FDA had cleared its investigational new drug (IND) application for OPGx-BEST1, a gene therapy candidate targeting bestrophin-1 (BEST1)-related inherited ...

8/20/2025
AcquisitionsDealsNewsletterRefractiveSurgical
Alcon’s Acquisition of STAAR Comes Amid Expansion Of Lens-Based Refractive Surgery
Alcon’s Acquisition of STAAR Comes Amid Expansion Of Lens-Based Refractive Surgery

Alcon will acquire STAAR Surgical in a deal that values the manufacturer of the Implantable Collamer Lens (ICL) at $1.5 billion, the companies announced Aug. 5. The move is occurring at a time when...

8/20/2025
NewsletterRegulationRetina
Nanoscope Targets Sight Restoration Instead of Blindness Prevention
Nanoscope Targets Sight Restoration Instead of Blindness Prevention

Ashish Patel, PhD, MBA, calls blind people “the most underserved population” in ophthalmology. Patel, senior vice president for sales and marketing at Nanoscope Therapeutics, said other drug compan...

8/20/2025
GlaucomaMIGSNewsletterSurgical
Novel Subconjunctival Devices Expected to Improve Treatment for More Advanced Glaucoma Patients
Novel Subconjunctival Devices Expected to Improve Treatment for More Advanced Glaucoma Patients

Improved glaucoma surgical devices and lasers are expected to drive healthy growth in procedure volume over the next five years. Subconjunctival devices, in particular, could alter the prospects fo...

8/20/2025
NewsletterPresbyopiaRegulation
US FDA Approves Lenz’ Vizz (Aceclidine) Drops for Presbyopia
US FDA Approves Lenz’ Vizz (Aceclidine) Drops for Presbyopia

Lenz Therapeutics announced July 31 that the US FDA had approved Vizz (aceclidine ophthalmic solution) 1.44% for presbyopia. The company said Vizz was the first once-daily, preservative-free eye dr...

8/20/2025
DiagnosticNewsletterRegulation
Select US FDA Approvals and Clearances in July 2025
Select US FDA Approvals and Clearances in July 2025

The US FDA’s ophthalmic device division granted clearance to one device using the 510(k) pathway in July 2025, according to the agency’s database. Tomey gained clearance for its Casia2 OCT anterior...

8/20/2025
BiosimilarsNewsletterRegulationRetina
US CMS Issues J-Code for Encelto, Q-Code for Yesafili for Billing Payers
US CMS Issues J-Code for Encelto, Q-Code for Yesafili for Billing Payers

The US Centers for Medicare and Medicaid Services (CMS) issued a J-code for Neurotech’s Encelto and a Q-code for Biocon Biologics’ Yesafili during Q2-2025. The codes take effect Oct. 1, 2025. In ad...

8/20/2025
CataractNewsletterRegulationRetinaSurgical
CMS Proposes Lower Physician Payments in 2026, Higher HOPD and ASC Fees
CMS Proposes Lower Physician Payments  in 2026, Higher HOPD and ASC Fees

US ophthalmologists are gaining some clarity on what their reimbursement for treating Medicare patients may look like in 2026. Documents published by the Centers for Medicare and Medicaid Services ...

8/20/2025
NewsletterRegulation
New HHS Plan Adds Prior Authorization to Medicare
New HHS Plan Adds Prior Authorization to Medicare

A new program by the US Department of Health and Human Services (HHS) to test using prior authorization for 15 procedures in traditional Medicare is raising concerns among Democratic lawmakers and ...

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