Omeros Corporation's OMS302 drug has met primary and secondary endpoints in the Phase 3 clinical trial conducted in patients undergoing intraocular lens replacement (ILR) surgery.
OMS302, which combines ketorolac, an anti-inflammatory agent, and phenylephrine, a mydriatic (pupil dilating) agent, is being developed for use during ILR surgery, cataract surgery and refractive lens exchange.
The Phase 3 clinical study is a multicentre double-blind trial that randomised (1:1) 405 patients to receive either OMS302 or placebo to evaluate maintenance of intraoperative mydriasis (pupil dilation) and change in postoperative pain.
The study showed that OMS302 met its primary endpoint by demonstrating maintenance of intraoperative mydriasis and superiority over placebo in reduction of pain in the early postoperative period.
In addition, OMS302 was well-tolerated and also achieved p values of less than 0.05 in a series of other clinically relevant measures.
OMS302 is added to standard irrigation solution used in ILR surgery and delivered intracamerally to maintain intraoperative mydriasis to prevent surgically induced miosis and to reduce postoperative pain and irritation.
Omeros chairman and chief executive officer Gregory Demopulos said following the recent meetings with US and European regulators, the company plans to begin enrolling patients in the second Phase 3 trial early next month and to submit marketing applications in both the US and Europe in the first part of 2013.
University of Utah Moran Eye Center ophthalmology and visual sciences senior vice chairman Alan Crandall said the data from the study is compelling and demonstrates that OMS302 addresses a universal need in lens replacement surgery.
"Given the drug's demonstrated effects on these two challenges facing all lens replacement surgeons, I expect that OMS302 could become widely used," Crandall added.
Associate professor of ophthalmology at Weill Cornell Medical College Mark Rosenblatt said, "The pain relief from this drug combination improves the surgical experience for the patient and assists the surgeon in pain management during the critical early postoperative period."