Ocugen Targets BLA Filings for Gene Therapy Programs by 2028

What happened

Ocugen plans to file biologics license applications (BLAs) next year for its retinitis pigmentosa and Stargardt disease programs, with potential approvals and launches in 2028. The company secured $130 million financing to fund operations through 2028 and completed manufacturing validation for OCU400.

Why it matters

The company is advancing a 'modifier gene' platform targeting rare inherited retinal diseases, aiming for one-time subretinal treatments. With over 325 patients treated and no serious adverse events reported, Ocugen seeks to improve patient access in major markets like the U.S., Europe, and Japan.