SEATTLE, July 2, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that the European Medicines Agency (EMA) approved a positive opinion issued by the European Pediatrics Committee (PDCO) agreeing to the Company's Pediatric Investigation Plan (PIP) for OMS302. EMA's approval of PDCO's positive opinion is a prerequisite for submission of the OMS302 Marketing Authorization Application (MAA) and, on completion of the post-marketing pediatric study, leads to an additional six months of patent exclusivity for OMS302 in Europe. OMS302, added to standard irrigation solution used during ophthalmological procedures, is Omeros' proprietary PharmacoSurgery™ product designed to maintain intraoperative mydriasis (pupil dilation), prevent surgically induced miosis (pupil constriction), and reduce postoperative pain resulting from cataract and other lens replacement surgery.
Omeros' PIP provides a study plan to evaluate the drug's safety and efficacy in patients 13-17 years old. Omeros received a waiver for studying the use of OMS302 in patients younger than 13 years and a deferral to complete the clinical study following EMA approval. With completion of the study as specified under the PIP, Omeros will be eligible to receive an additional six months of marketing exclusivity for OMS302 in the European Union (E.U.). This six-month period would extend beyond the expiration of Omeros' patents directed to OMS302, which will expire in the E.U. in 2023 for issued patents and 2033 for patents expected to issue from currently pending patent applications. This six-month extension is in addition to a supplementary protection certificate, which together could provide up to another five and one half years of market exclusivity for OMS302. Omeros is pursuing a similar but separate process in the U.S. for studying the use of OMS302 in pediatric patients, which is expected to lead to additional marketing exclusivity in the U.S. Submission of the New Drug Application (NDA) for OMS302 in the U.S. will precede the MAA submission, and both applications will include additional stability data to extend expiry dating at the time of expected commercial launch.
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