Ocugen said today that it launched a Phase III trial designed to evaluate its twice-daily 0.2% brimonidine tartrate eye drop in patients with dry eye disease.
Ocugen plans to run two identical Phase III trials of OCU310, enrolling 240 participants per study. The company said it will assess safety and efficacy results after just 28 days of treatment, due to the early potential therapeutic benefits of brimonidine tartrate that Ocugen observed in the Phase II study.
The Phase III trials’ primary endpoints are the change from baseline to four weeks in symptom assessment in dry eye (SANDE) score and the change in lissamine green conjunctival staining scores.
The company said it expects topline data in the second half of 2019.
“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 II study,” CMO Dr. Daniel Jorgensen said in prepared remarks.
“We are pleased to advance our second lead product candidate into Phase III clinical development,” chairman, CEO & co-founder Shankar Musunuri added. “OCU310 has the potential to improve the signs and symptoms in patients with DED as early as 28 days as opposed to existing therapies.”