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Omeros Announces Submission to European Medicines Agency of Paediatric Investigation Plan Letter of Intent for OMS302
Date:11/29/2011

SEATTLE, Nov. 29, 2011 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that it has submitted to the European Medicines Agency (EMA) a letter of intent to file its Paediatric Investigation Plan (PIP) for OMS302, the Company's product candidate for use during intra-ocular lens replacement surgery. A PIP is part of the EMA approval process and must be agreed prior to submission of a Marketing Authorization Application (MAA) for the drug in the European Union, unless the requirement is waived. A PIP describes how a company intends to evaluate the use of a given drug in children. Completion of studies outlined in the PIP prior to EU approval is not a requirement for MAA submission.

OMS302 is being evaluated in a Phase 3 clinical program enrolling both cataract surgery and refractive lens exchange patients.  The drug is added to standard irrigation solution used during cataract and other lens replacement surgery to maintain intraoperative mydriasis (pupil dilation) and reduce postoperative pain. Two randomized, double-blind, placebo-controlled, multicenter trials are planned. The first trial is underway in North America, and data are expected in the first quarter of 2012.  Omeros plans to initiate the second trial following discussions with regulators to ensure that data collected meet European expectations for marketing approval. The co-primary endpoints for these trials – maintenance of intraoperative pupil dilation (mydriasis) and reduction of postoperative pain – are the same as those achieved in the recently completed 221-patient Phase 2b trial. In that study, OMS302 was significantly superior to vehicle both in reducing postoperative pain and maintaining mydriasis.

"We remain on track to announce data from the initial Phase 3 trial of OMS302 in the first quarter of 2012," said Gregory A. Demopulos, M.D., chairman and chief e
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