Ocugen, Inc. Announces U.S. FDA Clearance of IND Amendment to Initiate OCU400 Phase 3 Clinical Trial — First Gene Therapy to Enter Phase 3 with a Broad Retinitis Pigmentosa Indication
“OCU400 is the first gene therapy program to enter Phase 3 with a broad RP indication.
- “OCU400 is the first gene therapy program to enter Phase 3 with a broad RP indication.
- Until now, there has been only one marketed product to treat one of the 100 gene mutations associated with RP.
- In the Phase 1/2 OCU400 clinical trial, a Multi-Luminance Mobility Testing (MLMT) scale was the primary functional endpoint.
- With the initiation of the Phase 3 clinical trial, OCU400 remains on track for the 2026 BLA approval target.