Ocugen’s Phase 1/2 study of OCU410 approved for continuation by DSMB

Ocugen (OCGN) announced that the Data and Safety Monitoring Board, or DSMB, for the OCU410 ArMaDa clinical trial recently convened and approved continuation of the second phase of the Phase 1/2 study. OCU410 is a novel modifier gene therapy candidate being developed for geographic atrophy, or GA, secondary to dry age-related macular degeneration, or dAMD. The ArMaDa clinical trial will assess the safety and efficacy of unilateral subretinal administration of OCU410 in subjects with GA. Phase 2 is an ongoing dose-expansion study in which 45 subjects are randomized in a 1:1:1 ratio to either one of two OCU410 treatment groups or an untreated control group. Positive preliminary efficacy and safety data from the Phase 1 dose-escalation portion of the ArMaDa clinical trial demonstrated: no drug-related serious adverse events, reduced lesion growth, preservation of retinal tissue, and-most importantly-there was a positive effect on the functional visual measure of low luminance visual acuity. dAMD is a multifactorial disease involving genetic and environmental factors that is one of the world’s leading causes of blindness in people aged 50 years and older. Dosing in the OCU410 ArMaDa clinical trial will be completed in early 2025 and the company will continue to provide 9- and 12-month efficacy updates from Phase 1.