Ocugen Inc. plans to submit Biologics License Applications for two lead gene therapy candidates in 2027. The company is developing OCU400 for retinitis pigmentosa and OCU410ST for Stargardt disease.
Management anticipates potential commercial launches as early as 2028. Phase III top-line data for OCU400 is expected in the first quarter of 2027. Phase II/III data for OCU410ST is scheduled for the second quarter of 2027.
A recent $130 million convertible note financing extends the company's cash runway into 2028. This capital covers all planned clinical and regulatory milestones through the filing period.
Ocugen has treated more than 325 patients across its programs to date. The company reports zero serious adverse events related to its therapies among those treated.