Ocugen Announces FDA Acceptance of Investigational NDA for OCU310 and Initiates Proof of Concept Study for Treatment of Dry Eye Disease

Source: Ocugen

Ocugen announced that the FDA accepted its investigational new drug (IND) application for OCU310 (brimonidine/steroid combination therapy), a topical formulation for the treatment of dry eye disease (DED). In addition, the company announced that its first patient was dosed in a proof of concept study. This randomized, placebo-controlled, double-blind, multicenter, proof of concept study will assess the tolerability and preliminary efficacy of OCU310 for the treatment of DED.

"We are very excited to begin our first clinical study and dose our first patient," Daniel Jorgensen, MD, Chief Medical Officer at Ocugen, said in a company news release. "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." 

"This is an important milestone for Ocugen as we enter the clinic and evaluate a new therapy for patients with dry eye disease," Dr. Shankar Musunuri, Chairman, CEO and Cofounder of Ocugen, said in the news 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."

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