The company announced 50 percent of enrollment in its Phase 3 clinical trial for OCU300 has been completed.
Ocugen (NASDAQ:OCGN) has announced it has completed 50 percent of patient enrollment in its Phase 3 clinical trial of OCU300 for patients with ocular Graft Versus Host Disease (oGVHD).
As quoted in the press release:
Ocugen is the first and only company to receive Orphan Drug Designation for a product candidate designed to treat oGVHD and is the first company to conduct a Phase 3 clinical trial in patients with this disease.
The ongoing Phase 3 trial is a double-masked, placebo-controlled 84-day trial, in which 60 patients will be randomized in a 2:1 ratio to receive either OCU300 (brimonidine 0.18% nanoemulsion) or a placebo. The purpose of the trial is to evaluate the safety and efficacy of brimonidine tartrate nanoemulsion eye drop solution in the treatment of ocular redness and ocular discomfort in patients with oGVHD. The trial has co-primary endpoints of ocular discomfort based on a 10-point visual analog scale and ocular redness based on a 100-point validated bulbar redness score.
Daniel Jorgensen, M.D., M.P.H., M.B.A., Chief Medical Officer of Ocugen, stated, “The achievement of 50% enrollment is a key milestone towards the completion of this important Phase 3 trial. oGVHD is a severe ocular autoimmune disease that occurs in up to 60% of allogeneic bone marrow transplant patients. There is no approved therapy for this debilitating condition, and it is our belief that OCU300 will provide needed relief for patients suffering from this disease.” Dr. Jorgensen continued, “We remain on track to report topline results from this trial in the second half of 2020.”