Ocugen Completes 140-Patient Phase III Enrollment, Extends Cash Runway into Q4 2026
Ocugen’s Q4 2025 R&D expenses rose to $39.8 million, net loss widened to $0.23 per share, and cash runway now extends into Q4 2026 (extendable to Q2 2027 with $30 million in warrant exercises). Enrollment is complete in the 140-patient Phase III liMeliGhT trial of OCU400, with top-line data expected in Q1 2027 and rolling BLA submission set for Q3 2026.
1. Q4 Financial Results and Cash Runway
Ocugen’s fourth-quarter R&D expenses rose to $39.8 million in 2025, widening net loss to $0.23 per share. Cash reserves support operations through Q4 2026, extendable into Q2 2027 if $30 million of warrants are exercised.
2. Phase III liMeliGhT Trial Completion
Enrollment in the Phase III liMeliGhT trial of OCU400 in retinitis pigmentosa has completed with 140 patients randomized 2:1 across RHO and gene-agnostic arms. The primary endpoint measures change in visual function via the Luminance Dependent Navigation Assessment, with top-line data expected in Q1 2027.
3. Stargardt and GA Program Highlights
The Phase II/III GARDian3 trial for Stargardt disease remains ahead of schedule, targeting top-line data in Q2 2027 with a single U.S. trial supporting a European filing. Preliminary Phase II ArMaDa results in geographic atrophy showed a 46% reduction in lesion growth at 12 months, with Phase III planned for 2026.
4. Regulatory and Commercialization Timeline
Ocugen plans a rolling BLA submission for liMeliGhT beginning Q3 2026, supported by ongoing process validation and manufacturing scale-up. Commercial preparations are underway for a potential 2027 launch, including marketing initiatives and regulatory engagement.