Omeros Says FDA Has Agreed to Pediatric Study Plan for OMS302

Omeros Corporation

today announced that the U.S. Food and Drug Administration (FDA) confirmed its agreement with the Pediatric Study Plan (PSP) proposed by Omeros to study the use of OMS302 in pediatric patients undergoing primary cataract extraction. The FDA also issued a Written Request consistent with the PSP, which means that 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 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. As announced in July, the European Medicines Agency approved Omeros' Pediatric Investigation Plan to study the use of OMS302 in pediatric patients, which is expected to lead to additional marketing exclusivity in Europe. Omeros has OMS302 marketing applications under review in the U.S. and Europe with anticipated market launch in 2014. Results of the pediatric studies are expected to be available during the post marketing period.