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FDA accepts investigational new drug application for Ocugen’s dry eye treatment
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The FDA has accepted an investigational new drug application for OCU310, a topical formulation for the treatment of dry eye disease, according to a press release from Ocugen.
Ocugen has also dosed its first patient in a randomized, placebo-controlled, double-masked, multicenter, proof of concept study to assess the tolerability and preliminary efficacy of OCU310 (brimonidine/steroid combination therapy) in dry eye.
“Our goal is to assess whether a combination product has potential benefit, in treating dry eye patients, while exploring the most appropriate endpoints for future pivotal studies,” Daniel Jorgensen, MD, Ocugen’s chief medical officer, said in the release.
“We know that current treatments are not reaching the majority of the population affected with dry eye disease, and we hope that our combination product may provide another therapeutic option for these patients,” added Shankar Musunuri, PhD, MBA, CEO and co-founder of Ocugen.