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Belite Bio completes enrollment in phase 2/3 DRAGON II trial for STGD1 | Ophthalmology Times
(Image Credit: AdobeStock/khunkornStudio) Belite Bio has completed enrollment in its phase 2/3 DRAGON II clinical trial evaluating tinlarebant for the treatment of Stargardt disease type 1 (STGD1). Tinlarebant is a novel oral therapy intended to reduce the accumulation of vitamin…
Opus Genetics launches phase 1/2 MERTK gene therapy trial | Ophthalmology Times
(Image Credit: AdobeStock/Dragon Claws) Opus Genetics has launched its clinical trial evaluating OPGx-MERTK gene therapy for MERTK-related retinitis pigmentosa (RP). The trial is funded through Abu Dhabi’s Healthcare Research and Innovation Fund. OPGx-MERTK is an investigational adeno-associated virus (AAV)-based gene…
FDA clears Novaliq’s Investigational New Drug application for NOV05 | Ophthalmology Times
(Image Credit: AdobeStock/Stock Contributor) The US Food and Drug Administration (FDA) has cleared Novaliq’s Investigational New Drug (IND) application for NOV05, enabling the initiation of the EYETAC phase II clinical trial (NCT07285070) in patients with non-infectious anterior uveitis (NIAU). NOV05,…
SpyGlass Pharma randomizes first patients in 2 phase 3 clinical trials of the BIM-IOL System | Ophthalmology Times
(Image Credit: AdobeStock/Pixel-Shot) SpyGlass Pharma has randomized the first patients in its 2 registrational phase 3 clinical trials of the Bimatoprost Drug Pad-IOL System (BIM-IOL System) for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or…
Q&A: Evolving approaches to geographic atrophy management | Ophthalmology Times
(Image Credit: AdobeStock/Prostock-studio) Management of geographic atrophy (GA) has changed with the introduction of retinal therapies aimed at slowing disease progression and with greater use of imaging for diagnosis and monitoring. These developments have raised practical questions about patient selection,…
Ocugen releases positive preliminary 12-month data from phase 2 ArMaDa trial | Ophthalmology Times
(Image Credit: AdobeStock/LORA) Ocugen has announced positive preliminary 12-month data from its phase 2 ArMaDa trial evaluating OCU410 (AAV5-RORA) for the treatment of geographic atrophy secondary to dry age-related macular degeneration. OCU410 is an investigational, intravitreally administered, AAV5-based gene therapy…
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…
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 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…