Ocugen, Inc. announced that the data and safety monitoring board (DSMB) for the ArMaDa clinical trial of OCU410 has reviewed interim safety data and approved the continuation of phase 2 of the trial. OCU410 (AAV5-hRORA) is a novel gene therapy for geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD). The DSMB reviewed data from 15 phase 2 subjects and found no serious adverse events (SAEs) related to OCU410. The therapy was deemed safe and well tolerated.

OCU410 targets multiple cellular pathways involved in dry AMD, including lipid metabolism, oxidative stress, inflammation, and complement. Preliminary results from phase 1 of the ArMaDa trial showed reduced lesion growth, preservation of retinal tissue, and improved low luminance visual acuity. The ongoing phase 2 study is a randomized, dose-expansion trial evaluating the safety and efficacy of OCU410 in 45 subjects. The treatment aims to provide a one-time solution to GA, potentially reducing the need for frequent intravitreal injections required by current treatments.

OCU410 utilizes an AAV platform to deliver the RORA gene, which plays a role in lipid metabolism and inflammation. The trial is being conducted at 13 retinal centers across the United States, with dosing expected to be completed in early 2025.

Read more in "Ocugen Reports Preliminary Data from Gene Therapy Trial."