Ocugen's IND Amendment To Commence OCU400 Phase 3 Trial Gets FDA Approval

(RTTNews) - Monday, Ocugen, Inc.(OCGN) revealed that the FDA has approved the Company's Investigational New Drug or IND amendment to commence a Phase 3 clinical trial of OCU400.

OCU400 is a gene therapy product designed for retinitis pigmentosa, a collection of rare genetic disorders that result in vision loss and blindness.

The Phase 3 trial is set to include 150 participants, divided into two arms: one with 75 participants carrying the RHO gene mutation and the other with 75 gene-agnostic participants. Each arm will be randomized 2:1 to either the treatment group, receiving 2.5 x 10^10 vg/eye of OCU400 or the untreated control group.

The company stated that the commencement of the Phase 3 clinical trial keeps OCU400 on course for the 2026 BLA approval target.