Omeros Corporation (OMER)

[surf1944]

7:04AM Omeros Submits OMS302 marketing authorization application to European Medicines Agency (OMER) 5.25 : Co announced that it recently submitted a Marketing Authorization Application to the European Medicines Agency seeking approval to market OMS302 for use in patients undergoing intraocular lens replacement surgery in the European Union. Added to standard irrigation solution used during ILR, OMS302 is Omeros' proprietary PharmacoSurgery product that, across multiple human trials, demonstrated clinically meaningful and statistically significant maintenance of intraoperative mydriasis (pupil dilation), prevention of intraoperative miosis (pupil constriction), and reduction of postoperative ocular pain.

With the submission by Omeros of a New Drug Application (NDA) for OMS302 to the FDA in July 2013, the MAA represents Omeros' second major submission seeking regulatory authorization to market OMS302. The EMA previously granted OMS302 eligibility for centralized review, determining that the product represents a significant therapeutic innovation.