Ocugen touted positive data today from a Phase II proof-of-concept trial for its dry eye disease combination therapy, OCU310, which combines brimondine tartrate and loteprednol etabonate.
The company’s randomized trial met its primary tolerability endpoint and showed meaningful improvements across endpoints related to the symptoms of dry eye disease, according to Ocugen.
The Malvern, Pa.-based company said it plans to bring OCU310 into Phase III trials in the third quarter of 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 III studies,” CMO Dr. Daniel Jorgensen said in prepared remarks. “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,” chairman, CEO & co-founder Shankar Musunuri said.
“We anticipate further differentiating OCU310 as we move into Phase III studies, utilizing our enhanced and proprietary nanoemulsion preservative-free formulation of brimonidine and loteprednol in single use vials,” he added.