Enrollment in ocular graft-versus-host disease trial halfway complete
Ocugen has completed 50% of enrollment for a phase 3 trial of OCU300 for the treatment of ocular redness and discomfort in patients with ocular graft-versus-host disease, according to a press release.
The double-masked, placebo-controlled 84-day trial will include 60 patients randomly assigned 2:1 to receive OCU300 (brimonidine 0.18% nanoemulsion) or placebo.
“The achievement of 50% enrollment is a key milestone towards the completion of this important phase 3 trial. [Ocular graft-versus-host disease] is a severe ocular autoimmune disease that occurs in up to 60% of allogeneic bone marrow transplant patients,” Daniel Jorgensen, MD, MPH, MBA, Ocugen chief medical officer, said in the release. “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.”
Topline results of the trial are expected in the second half of 2020.