Ocugen, Inc. announced topline 12-month data from the Phase 2 ArMaDa clinical trial of OCU410 modifier gene therapy for geographic atrophy secondary to dry age-related macular degeneration, with the optimal (medium) dose showing a statistically significant 31% reduction in lesion growth versus control (lesions ≥2.5 mm² and ≤17.5 mm², N=39). The company scheduled a conference call and webcast for March 24, 2026, at 8:00 a.m. EDT to discuss the data.
Key takeaways
Phase 2 ArMaDa trial: medium dose 31% reduction in GA lesion growth vs control at 12 months (p-value via MMRM, lesions ≥2.5 mm² ≤17.5 mm², N=39 evaluable)
High dose: 16% reduction in lesion growth vs control (same criteria)
For stricter lesions ≥5 mm² ≤17.5 mm² (N=31): medium 33%, high 31% reduction vs control
No OCU410-related SAEs or AESIs reported; all CNV unrelated per DSMB
Optimal dose (medium) intended for Phase 3; primary analysis p-value with 95% power targeted 3Q 2026
Conference call/webcast March 24, 2026, 8:00 a.m. EDT; presentations in Exhibits 99.2 and 99.3