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
Uncategorized