Ocugen reported preliminary results from the dose-escalation portion of its Phase 1/2 ArMaDa clinical trial (NCT06018558) evaluating subretinal administration of its modifier gene therapy OCU410 in patients with geographic atrophy (GA). Key findings from the low-dose (2.5×10¹⁰ vg/mL) cohort at 6 months include reduced lesion growth, preserved retinal tissue, and stabilization of visual function as measured by low luminance visual acuity, the company said in a press release. 

According to Ocugen, OCU410 is a gene therapy platform that delivers the nuclear hormone receptor NR2E3 to the retina and retinal pigment epithelium, to preserve and potentially restore retinal structure and function. Trial data indicated that lesion growth was 21.4% slower in treated eyes compared to untreated ones, with outcomes comparing favorably to existing treatments. Unlike currently approved therapies, which require frequent injections, OCU410 offers the potential for 1-time treatment, the company said. 

Phase 2 of the ArMaDa trial is a randomized dose-expansion cohort, in which 45 subjects will be randomized in a 1:1:1 ratio into one of the two treatment arms or an untreated control group. Patients in the treatment arms will receive a medium dose (5×10¹⁰ vg/mL) or high dose (1.5 ×10¹¹ vg/mL) of OCU410. Up to 13 retinal surgery centers across the United States are participating in the ArMaDa trial. At Ocugen’s clinical showcase earlier this month, the company reported that it plans to complete dosing in the second half of 2025.