Ocugen says DSMB approves medium dose cohort dosing in OCU410 study

Ocugen announced that the Data and Safety Monitoring Board for the Phase 1/2 ArMaDa clinical trial for OCU410 recently convened and approved to proceed dosing with the medium dose of OCU410 in the dose-escalation phase of the study. Three subjects with geographic atrophy were dosed in the Phase 1/2 clinical trial to date. An additional three subjects will be dosed with the medium dose and three patients with the high dose of OCU410 in the dose-escalation phase. Currently approved products to treat GA have significant limitations, as they require multiple injections per year and only target one pathway contributing to GA. OCU410 regulates multiple pathways involved with the disease including: lipid metabolism, inflammation, oxidative stress, and membrane attack complex. The ArMaDa 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.