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Ophthalmology pipeline watch: Key trial results and PDUFA dates for Q1 2026 | Ophthalmology Times
(Image Credit: AdobeStock/Iuliia Pilipeichenko) Editor’s Note: This content was generated with the assistance of AI. Clinical trial watchers can anticipate the release of data from a number of trials in the first quarter of 2026. The trials focus on Leber hereditary…
Rayner announces Sophi Phaco System in the US | Ophthalmology Times
The FDA has given 501(k) clearance to Rayner’s Sophi (Swiss Ophthalmology Innovation) Phacoemulsification System, making it available to cataract surgeons in the US, according to the company.1 The platform was designed with a focus on mobility, simplicity, and safety, which…
Ocugen publishes phase 1 GARDian1 gene therapy data for Stargardt disease | Ophthalmology Times
(Image Credit: AdobeStock/amazing studio) Ocugen has announced the publication of positive results from its phase 1 GARDian1 trial of OCU410ST, a gene therapy for Stargardt disease. Data was published in the peer-reviewed journal Nature Eye, which is published by the Royal…
Study shows significant ocular changes following hemodialysis | Ophthalmology Times
(Image Credit: AdobeStock/Kiryl Lis) A new study from Poland found that one session of hemodialysis caused changes in the anterior and posterior segments of the eye.1 The investigators, led by Joanna Roskal-Wałek, MD, published their results in the Journal of…
FDA grants Fast Track Designation to Complement Therapeutics’ CTx001 for geographic atrophy | Ophthalmology Times
(Image Credit: AdobeStock/Tada Images) The US Food and Drug Administration (FDA) has granted Fast Track Designation to Complement Therapeutics’ CTx001, the company’s lead gene therapy candidate for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The…
First patient treated in dose-expansion portion of SpliceBio’s phase 1/2 ASTRA clinical trial | Ophthalmology Times
(Image Credit: AdobeStock/Ilya) SpliceBio has dosed the first patient in the Part B dose-expansion portion of its phase 1/2 ASTRA clinical trial (NCT06942572) evaluating SB-007 for the treatment of Stargardt disease. SB-007 is an investigational dual adeno-associated virus (AAV) gene…
Glaucoma innovation: Eight themes to watch in 2026 | Ophthalmology Times
Glaucoma care is evolving through the integration of artificial intelligence, advanced procedures, and personalized treatment strategies. (Image credit: AdobeStock/thodonal) As the ophthalmology community observes Glaucoma Awareness Month this January, glaucoma specialists point to incremental integration of technologies that support earlier…
New optoretinography technique allows direct measurement of rod function in vivo | Ophthalmology Times
(Image Credit: AdobeStock/neosiam) A press release from the University of Washington, Seattle, reported what they described as a future diagnostic tool to view how the ocular molecules work. “Researchers have validated an approach to measure how rod photoreceptors, the cells…
iOpeners with Nicole Bajic, MD: Mary Qiu, MD, on tailored NVG pathways | Ophthalmology Times
With January being Glaucoma Awareness Month, it seems fitting to discuss neovascular glaucoma (NVG), a challenging and vision-threatening condition that requires thoughtful, individualized management. In this episode of iOpeners from Ophthalmology Times, host Nicole Bajic, MD, comprehensive ophthalmologist at the…
FDA update: Outlook Therapeutics receives CRL for resubmitted ONS-5010 BLA | Ophthalmology Times
Outlook Therapeutics, Inc. reported that the FDA has issued a complete response letter (CRL) concerning the resubmitted biologics license application (BLA) for ONS-5010/LYTENAVA (bevacizumab-vikg).1,2 The letter noted that the agency cannot approve the application in its current form for the…