Ocugen’s OCU410 Cuts Lesion Growth 31%, Phase III Set for Q3 2026
Ocugen’s Phase II ArMaDa trial of OCU410 in geographic atrophy showed a 31% reduction in macular lesion growth at 12 months, versus 46% in early analysis, with 55% of treated patients achieving ≥30% lesion size reduction. Safety profile was clean, and Phase III starts Q3 2026 with 300 patients.
1. Phase II Readout Details
In the ArMaDa Phase II study, a single subretinal administration of OCU410 delivered a 31% reduction in macular lesion growth at 12 months compared with control, down from a preliminary 46% reduction. Additionally, 55% of treated patients achieved a lesion size drop of 30% or more versus control.
2. Safety and Tolerability
The trial demonstrated a favorable safety profile with no serious treatment-emergent adverse events reported to date. All observed events were mild, transient, and resolved without intervention, supporting continued clinical development.
3. Next Steps and Market Context
Ocugen plans to initiate a pivotal Phase III trial in Q3 2026, aiming to enroll up to 300 geographic atrophy patients. If approved, OCU410 would offer a one-time surgical alternative to chronic intravitreal injections like Apellis’s Syfovre and Astellas’s Iservay.