Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy

Summary

This is a Phase 1/2 Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration (AMD). This is a multicenter study, which will be conducted in two phases and will enroll up to a total of 60 subjects.

Timeline

Start

2023-02-23

Primary completion

2026-02-17

Completion

2026-05-29

Outcome

Met primary endpoint

release “Positive 12-month data from the OCU410 Phase 2 ArMaDa clinical trial for geographic atrophy (GA) indicates a statistically significant (p<0.05) 31% reduction in lesion size” ocugen.com ↗

release “positive 12-month Phase 2 ArMaDa data (statistically significant 31% reduction in GA lesion growth versus control” ocugen.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	OCU410	Gene therapy (AAV / viral vector)	2.5e+10 vg	Other
Subject	OCU410	Gene therapy (AAV / viral vector)	5e+10 vg	Other
Subject	OCU410	Gene therapy (AAV / viral vector)	1.5e+11 vg	Other

Indications