Ocugen announces dosing completion of Cohort 2 in OCU410 Phase 1/2 trial

Ocugenannounced that dosing is complete in the second cohort of its Phase 1/2 ArMaDa clinical trial for OCU410, a modifier gene therapy candidate being developed for geographic atrophy, an advanced stage of dry age-related macular degeneration. GA affects approximately 1 million people in the United States alone. Dosing in the second cohort is complete and 3 subjects received 200 mL single subretinal administration of the medium dose of OCU410. Up to 13 leading retinal surgery centers across the United States are participating in the ArMaDa clinical trial. A Data and Safety Monitoring Board meeting will convene next month to review the 4-week safety data of the medium dose cohort before proceeding with high dose, which is the final dose in the Phase 1 dose-escalation study. The ArMaDa Phase 1/2 clinical trial will assess the safety of unilateral subretinal administration of OCU410 in subjects with GA and will be conducted in two phases. Phase 1 is a multicenter, open-label, dose-ranging study consisting of three dose levels low dose, medium dose, and high dose. Phase 2 is a randomized, outcome accessor-blinded, dose-expansion study in which subjects will be randomized in a 1:1:1 ratio to either one of two OCU410 treatment groups or to an untreated control group.