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Omeros Announces Positive OMS302 Safety Data in Phase 3 Clinical Trial
Date:1/22/2013

SEATTLE, Jan. 22, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced the successful completion of the 90-day safety database lock in the second of the Company's two pivotal Phase 3 clinical trials evaluating OMS302 in patients undergoing intraocular lens replacement surgery. 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. In November 2012, Omeros announced that OMS302 met the co-primary efficacy endpoints in this second pivotal Phase 3 clinical trial 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.

This multicenter, double-blind, Phase 3 clinical trial enrolled 416 patients randomized 1:1 to receive either OMS302 or placebo. Safety data were collected through postoperative day 90. In this Phase 3 clinical trial, OMS302 was well tolerated. The incidence of adverse events was similar between the two treatment groups, and the adverse event profile was similar to that seen in prior OMS302 clinical trials. No safety concerns have been identified in the OMS302 clinical development program. Results from this study are expected to be presented at an upcoming major ophthalmology meeting. Omeros also plans to publish the results in a leading peer-reviewed ophthalmology journal.

"While these data were expected, they underscore the safety benefits of intraoperative and local delivery of OMS302 – administration of efficacious and low concentrations of the active ingredients directly to the surgical site reduces systemic uptake an
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SOURCE Omeros Corporation
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