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Ocugen begins phase 3 trials of treatment for ocular graft-versus-host disease

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Ocugen has begun two pivotal phase 3 clinical trials of OCU300 for the treatment of ocular discomfort and ocular redness in patients with ocular graft-versus-host disease, the company announced in a press release.

An investigational new drug application for OCU300 (brimonidine tartrate formulated in a proprietary nanoemulsion) was recently accepted by the FDA.

The two randomized, double-masked, placebo-controlled studies will examine the efficacy of OCU300. Both studies will be staggered, evaluating approximately 60 patients who will receive OCU300 or placebo eye drops for 84 days, the release said.

“We are excited to advance OCU300 into pivotal-stage clinical development and to potentially deliver to [ocular] GVHD patients the first FDA-approved therapy to address this condition,” Daniel Jorgensen, MD, MPH, chief medical officer of Ocugen, said in the release.