Ocugen’s Dry Eye Treatment Hits Primary Endpoint
Ocugen’s Dry Eye Treatment Hit Its Primary Endpoint
By Alex Keown
Ocugen, Inc. has its eyes set on making a mark in the dry eye treatment arena. The Pennsylvania-based company announced this morning that its mid-stage combination treatment hit its primary endpoint of tolerability in a proof-of-concept trial.
OCU310, Ocugen’s combination of brimondine tartrate and loteprednol etabonate, a corticosteroid, met its primary endpoint of tolerability over a 12-week period and also demonstrated meaningful improvements across a number of endpoints related to the signs and symptoms of dry eye disease when compared to placebo, the company said. Both key ingredients in OCU310 have been previously approved by the U.S. Food and Drug Administration, which “significantly derisks OCU310” as it moves through the regulatory process, the company said. Ocugen is looking to take its combination therapy into Phase III testing in the third quarter of this year.
One thing that regulatory officials and industry observers will watch closely is statistical significance when it comes to efficacy. Ocugen said the Phase II trial was not powered to show that. The company did say prespecified exploratory efficacy endpoints to assess changes in key signs and symptoms of dry eye disease were evaluated. The company said symptom endpoints using the Symptom Assessment Questionnaire in Dry Eye (SANDE) scale, which measures the frequency and severity of eye dryness/irritation, showed consistent improvement in scores from baseline. Ocugen said it saw “consistently greater reductions in SANDE score for the OCU310 group compared to patients who received placebo,” which indicates a greater degree of relief from dry eye discomfort. The company did not provide those measures in its announcement.
Dry eye disease affects about 6 percent to 34 percent of adults globally and about 16 million people in the United States. The disease is most commonly associated with dryness and overall eye discomfort, as well as stinging, burning or fluctuating blurry vision.
In the Phase II trial patients were treated with drops twice daily for 12 weeks. They were assessed for tolerability using a visual analog scale. Results showed that tolerability was similar for patients receiving OCU310 or placebo at all post-baseline visits through week 12.
Daniel Jorgensen, Ocugen’s chief medical officer, said company leadership was pleased with the trial results and the fact that OCU310 met its primary endpoint of tolerability.
“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,” Jorgensen said in a statement.
Ocugen Chief Executive Officer Shankar Musunuri echoed Jorgensen’s excitement. He said the key potential differentiators for OCU310, which include its rapid onset of action, its tolerability and its “unique potential” to relieve dry eye discomfort, will make OCU310 a preferred treatment option for prescribers and patients should it be approved.
“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,” Musunuri said.