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Omeros' Ophthalmology Product OMS302 Successful in Second Phase 3 Clinical Trial
Date:11/5/2012

SEATTLE, Nov. 5, 2012 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today reported positive data from the second of its two pivotal Phase 3 clinical trials evaluating OMS302 in patients undergoing intraocular lens replacement surgery.  In this second Phase 3 clinical trial comparing OMS302 to placebo, OMS302 met its co-primary endpoints by demonstrating statistically significant (p<0.00001) maintenance of intraoperative mydriasis (pupil dilation) and statistically significant (p=0.0002) reduction of pain in the early postoperative period. 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. Now with positive data from both trials in the OMS302 Phase 3 clinical program, Omeros plans to submit a New Drug Application (NDA) with the U.S. Food and Drug Administration in the first half of 2013 and a Marketing Authorization Application (MAA) with the European Medicines Agency in mid-2013, potentially allowing sales in 2014.

This multicenter, double-blind, Phase 3 clinical trial enrolled 416 patients randomized 1:1 to receive either OMS302 or placebo. The co-primary endpoints were maintenance of intraoperative mydriasis (pupil dilation) and reduction of pain in the early postoperative period.  Mydriasis is critical to the safety and surgical ease of lens replacement surgery as intraoperative pupil constriction increases the risk of injury to intraocular structures and can substantially prolong surgical time.  OMS302 also achieved statistical significance in other clinically relevant measures. The results from this trial are consistent with those from Omeros' first OMS302 Phase 3 and earlier Phase 2b clinical trials.

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