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  • FDA approves study of phenylephrine-ketorolac combo in children

    Omeros Corporation
    Cataract/Anterior Segment, Pediatric Ophth/Strabismus
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    Omeros Corp. has received permission from the FDA to study its proprietary combination of phenylephrine and ketorolac, OMS302, in pediatric patients undergoing primary cataract extraction.

    The FDA confirmed its agreement with the Pediatric Study Plan (PSP) proposed by Omeros. Successful completion of the PSP would make OMS302 eligible for an additional six months of marketing exclusivity in the U.S.

    Added to standard irrigation solution used during ophthalmological procedures, OMS302 is designed to maintain intraoperative mydriasis, prevent surgically induced miosis, and reduce postoperative pain resulting from cataract and other lens replacement surgery.

    Omeros has OMS302 marketing applications under review in the U.S. and Europe, with the product expected to launch in 2014.

    Results of the pediatric studies are expected to be available during the post-marketing period.