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, multi-center, 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, M.D., MPH, Chief Medical Officer of Ocugen, said. “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."
OCU310 is a unique ophthalmic nanoemulsion/suspension product being developed as a treatment for dry eye disease. It contains a proprietary nanoemulsion of brimonidine tartrate (0.2%), an FDA-approved ophthalmic drug with unique anti-inflammatory, immunosuppressive, vasoconstrictive and analgesic properties, combined with a low dose of loteprednol etabonate (0.2%), an FDA approved corticosteroid for ophthalmic use. The fact that both active components of the OCU310 combination product are approved by FDA for ophthalmic use, significantly derisks OCU310 from a product safety and regulatory (505(b)(2) pathway) standpoint. These active components, which have complementary mechanisms of action, could result in an enhanced product profile compared to currently marketed products for dry eye. OCU310 is expected to have a more rapid onset of action, improved tolerability and more potent relief from dry eye signs and symptoms due to its novel nanoemulsion formulation of brimondine combined with loteprednol.