Ocugen has initiated a Phase 3 clinical trial for its second lead product candidate, OCU310 for patients with dry eye disease (DED). OCU310 is an investigational twice-daily, steroid-free, preservative-free eye drop of 0.2% brimonidine tartrate formulated with Ocugen's proprietary nanoemulsion technology, OcuNanoE.
Dry eye disease is a common ocular disorder involving the aberrant production, composition and instability of tear film, which results in damage to the ocular surface and is correlated with symptoms of ocular pain or discomfort and signs of ocular surface inflammation. DED can cause long-term damage to the ocular surface, and in severe cases, can result in vision impairment. It is estimated that there are approximately 35 million adult patients affected by DED in the U.S., with an estimated 16 million patients diagnosed.
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"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, Chief Medical Officer of Ocugen, said.
"We are pleased to advance our second lead product candidate into Phase 3 clinical development. OCU310 has the potential to improve the signs and symptoms in patients with DED as early as 28 days as opposed to existing therapies. We expect to report topline data in the second half of 2019," Shankar Musunuri, PhD, MBA, Chairman, CEO and Co-Founder of Ocugen, said.