Ocugen, Inc. Announces Positive Scientific Advice from the European Medicines Agency Related to the Approval Pathway for OCU400—Modifier Gene Therapy for Broad Retinitis Pigmentosa Indication
EMA provided this opinion based on safety and tolerability of OCU400 demonstrated in the Phase 1/2 study.
- EMA provided this opinion based on safety and tolerability of OCU400 demonstrated in the Phase 1/2 study.
- In each arm, participants will be randomized 2:1 to the treatment group (2.5 x 1010 vg/eye of OCU400) and untreated control group, respectively.
- The positive scientific advice from EMA is in alignment with U.S. FDA clearance of the IND amendment to initiate the Phase 3 liMeliGhT clinical trial of OCU400.
- OCU400 is the first gene therapy to enter Phase 3 with a broad RP indication.