Ocugen Announces Update on OCU400 Phase 1/2 Clinical Trial Targeting Retinitis Pigmentosa and Leber Congenital Amaurosis
MALVERN, Pa., Dec. 07, 2022 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that the Data Safety and Monitoring Board (DSMB) for the OCU400 clinical trial recently convened and established high dose as the maximum tolerable dose (MTD) in the dose-escalation phase of the study.
- “No serious adverse events (SAEs) related to OCU400 have been reported to date.”
10 patients with NR2E3 and RHO gene mutations associated with RP have been dosed in the Phase 1/2 clinical trial to date. - Data from the MTD has the potential to navigate strategy for the planned Phase 3 study in the U.S. and other major markets.
- The Company plans to file a Biologics License Application (BLA) for OCU400 in 2025.
- Ocugen is committed to finding solutions for people with inherited retinal disease for whom no effective treatment options exist.