Omeros Corp. (OMER) said its ophthalmology product OMS302 met its primary and secondary end points in Phase 3 clinical trial in patients undergoing intraocular lens replacement surgery.
According to the company, OMS302 achieved its primary endpoint by demonstrating statistically significant maintenance of intraoperative mydriasis, also called pupil dilation. OMS302 also showed statistical superiority over placebo in reduction of pain in the early postoperative period. The data for both endpoints are clinically meaningful.
OMS302, added to standard irrigation solution used during ophthalmological procedures, is Omeros' proprietary PharmacoSurgery product designed to maintain intraoperative mydriasis and reduce postoperative pain and irritation resulting from cataract and other lens replacement surgery.
"...This achievement marks our transition to a company preparing, rather than hoping, to commercialize our first product," said Gregory Demopulos, chairman and chief executive officer of Omeros. "Following our recent successful meetings with U.S. and European regulators, we plan to begin enrolling patients in our second Phase 3 trial early next month and to submit marketing applications in both the U.S. and Europe in the first part of 2013."
by RTT Staff Writer
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