Ocugen, Inc. announced that dosing is complete in the second cohort of its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV-hRORA)--a modifier gene therapy candidate being developed for geographic atrophy (GA), an advanced stage of dry age-related macular degeneration (dAMD). 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 (5x1010 vg/mL) 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. 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. The Company will continue to provide clinical updates on an ongoing basis.