Ocugen has initiated a phase 3 clinical trial of its dry eye disease treatment OCU310, the company announced in a press release.
OCU310 (brimonidine tartrate 0.2%), an investigational twice-daily, steroid-free, preservative- free eye drop, is formulated with OcuNanoE, Ocugen’s proprietary nanoemulsion technology, the release said.
“We believe OCU310 could be an important treatment option for the management of DED, based on brimonidine’s multiple modes of action, our OcuNanoE formulation technology and the favorable results of our recent phase 2 study,” Daniel Jorgensen, MD, MPH, Ocugen chief medical officer, said in the release.
There will be two placebo-controlled phase 3 trials in the program, each including 240 patients. The primary endpoints of the trial are the change from baseline to 4 weeks in Symptom Assessment in Dry Eye score and the change from baseline in lissamine green conjunctival staining score after 4 weeks. Topline data are expected in the second half of 2019.