FDA Alignment for Phase 2/3 Trial
Ocugen reached an alignment with the FDA to move forward with a Phase 2/3 pivotal confirmatory trial for OCU410ST BLA targeting Stargardt disease, potentially expediting their clinical development timeline by two to three years.
Secured Financing
Ocugen secured $65 million in equity and debt financings in the second half of 2024, extending their cash runway into the first quarter of 2026.
Positive Clinical Trial Results
OCU400 showed statistically significant improvement in visual function with a p-value of 0.005, and OCU410ST showed a significant p-value of 0.02 for visual acuity improvement in treated eyes.
Advanced Therapy Medicinal Product (ATMP) Classification
OCU400 and OCU410ST received ATMP classification from the European Medicines Agency, accelerating regulatory review timelines.
Strong Cash Position
Cash and restricted cash increased to $58.8 million as of December 31, 2024, compared to $39.5 million at the end of 2023.