Advancement of Modifier Gene Therapy Platform
Ocugen is on track to file three Biologics License Applications (BLA) or Market Authorization Applications (MAA) in the next three years for its modifier gene therapy platform, targeting retinal diseases.
Positive Clinical Data for OCU400
Two-year safety and efficacy data from the Phase 1/2 OCU400 clinical trial showed a statistically significant improvement in visual function with a p-value of 0.005, indicating potential to treat approximately 300,000 RP patients in the US and EU and 1.6 million globally.
EMA's MAA Submission Eligibility for OCU400
EMA granted eligibility to submit OCU400 MAA via centralized procedure as an ATMP, signifying recognition of its potential to address unmet medical needs in Europe.
Initiation of OCU410 Phase 3 Trials
Dosing was completed ahead of schedule in the OCU410 Phase 1/2 trial for geographic atrophy, with Phase 3 trials set to begin in 2026, aiming for a BLA submission in 2028.
OCU410ST Progress
Significant improvements were shown in the Phase 1 GUARDIAN trial, and the FDA approved a Phase 2/3 trial for Stargardt disease.
Financial Stability and Strategy
Cash runway is expected to extend into the first quarter of 2026, with ongoing exploration of strategic opportunities to increase working capital.