Ocugen announced positive results from its phase 2 proof-of-concept clinical trial of OCU310, a novel combination of brimondine tartrate and a corticosteroid, loteprednol etabonate, being developed as a treatment for dry eye disease. The randomized, multicenter, double-blinded, placebo-controlled study met its primary endpoint of tolerability over a 12-week period. The study results also showed meaningful improvements across a number of endpoints related to the signs and symptoms of dry eye disease when compared to placebo. Based on these encouraging results, Ocugen remains on track to advance OCU310 into phase 3 clinical studies in the third quarter 2018.
"We are pleased to have met our primary objective of showing tolerability and consistently greater reductions in key exploratory efficacy endpoints, especially potential sign and symptom endpoints for phase 3 studies," Daniel Jorgensen, MD, MPH, Chief Medical Officer of Ocugen, said in a company news release. "We believe OCU310 can provide significant benefit to those suffering from dry eye disease, and we look forward to presenting the full results at a future academic meeting, and discussing with the FDA in the coming months."
"We are very encouraged by these results. We believe key potential differentiators for OCU310, such as rapid onset of action and the unique potential for OCU310 to relieve dry eye discomfort, as well as potentially enhanced tolerability to support its long-term use, will drive favor for OCU310 among prescribers and patients," Shankar Musunuri, PhD, MBA, Chairman, CEO and Co-Founder of Ocugen, said in the news release. "We anticipate further differentiating OCU310 as we move into Phase 3 studies, utilizing our enhanced and proprietary nanoemulsion preservative-free formulation of brimonidine and loteprednol in single use vials."