Ocugen Shares Positive OCU410 Trial Results for GA

Ocugen has released encouraging preliminary findings from the Phase 1 portion of its Phase 1/2 OCU410 ArMaDa clinical trial, focused on treating geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). The results demonstrate the potential of OCU410 as a transformative therapy for GA.

Key Findings from the OCU410 Trial

The trial includes nine patients across three dose cohorts, with results from the low-dose group showing promising outcomes after six months:

• Safety: No drug-related serious adverse events were reported.

• Efficacy: Treated eyes exhibited a 21.4% slower lesion growth compared to untreated eyes, outperforming published data on monthly and bi-monthly pegcetacoplan injections.

• Structural Benefits: Improved retinal tissue preservation around GA lesions.

• Functional Outcomes: Stabilization of low luminance visual acuity (LLVA) in 100% of treated eyes, indicating preserved visual function.

“These results demonstrate the potential for OCU410 to address both structural and functional aspects of geographic atrophy,” said Dr. Huma Qamar, Ocugen’s Chief Medical Officer. “As a one-time treatment, it could revolutionize the management of dry AMD.”

Addressing a Critical Unmet Need

Currently, treatment options for GA remain limited:

• In Europe, no approved therapies exist.

• In the United States, the only available treatment is anti-complement therapy, which requires frequent injections and addresses only part of the disease process.

Expert Insights

Dr. Syed M. Shah, Vice Chair for Research & Digital Health at Emplify Health, commented:

“Currently approved treatments for GA have not shown significant benefit in visual function. The logistical challenge and emotional burden of frequent injections for patients and caregivers cannot be overstated. OCU410’s potential as a ‘one-and-done’ treatment paradigm could be a gamechanger, addressing both structural and functional outcomes.”