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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…
FDA clears first daily disposable EDOF contact lens for presbyopia | Ophthalmology Times
The US FDA has officially cleared the first and only daily disposable soft (hydrophilic) contact lens for presbyopia that utilizes patented Extended Depth of Focus (EDOF) optical design technology.1 The Cataltheia Group and its US subsidiary Bruno Vision Care stated…
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…
Nanoscope secures new US patent for Multi-Characteristic Opsin (MCO) technology platform | Ophthalmology Times
(Image Credit: AdobeStock/Timon) Nanoscope has received a new patent (US Patent No. 12459977) from the US Patent and Trademark Office (USPTO) for the company’s Multi-Characteristic Opsin (MCO) technology platform as a novel and innovative synthetic opsin for optogenetic modulation. MCO is…
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…
Ollin Biosciences reports positive head-to-head phase 1b data for OLN324 vs faricimab | Ophthalmology Times
(Image Credit: Adobe Stock/fotofabrika) Ollin Biosciences has announced positive topline results from its randomized, head-to-head phase 1b JADE clinical study comparing OLN324 to faricimab (Vabysmo). The JADE clinical study enrolled more than 160 patients with diabetic macular edema (DME) or…
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…