Safety monitoring board approves continuation of gene therapy trial for GA

Key takeaways:

• The ArMaDa trial is investigating unilateral subretinal administration of OCU410, a gene therapy for geographic atrophy.
• No serious ocular adverse events have been reported so far.

The data and safety monitoring board for a phase 1/2 study clinical trial of a geographic atrophy gene therapy approved continuation of the second phase of the study due to positive safety results, according to a press release from Ocugen.

The ArMaDa study is investigating the unilateral subretinal administration of OCU410 for geographic atrophy secondary to dry age-related macular degeneration. The ongoing, randomized, outcome assessor-blinded, dose-expansion phase 2 study randomly assigned 45 patients to either one of two OCU410 treatment groups (5×10¹⁰ vg/mL or 1.5 ×10¹¹ vg/mL) or a control group.

The data and safety monitoring board evaluated 15 participants with GA enrolled in the phase 2 study and reported no serious adverse events, the release said. Additionally, positive data from phase 1 showed no drug-related serious adverse events, reduced lesion growth, retinal tissue preservation and a positive effect on of low luminance visual acuity.

Ocugen anticipates ArMaDa’s dosing will be finished in early 2025.

“Currently approved treatments for GA require six to 12 intravitreal injections annually and frequent injections are a burden on patients and caregivers,” Huma Qamar, MD, MPH, CMI, chief medical officer of Ocugen, said in the release. “We are very enthusiastic about the potential of OCU410 to serve as a game-changing, one-time treatment for life for patients with GA.”

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