FDA, EMA Accept OMS302 Marketing Applications for Review

Omeros Corporation

announced today that the New Drug Application (NDA) for its ophthalmology product, OMS302, has been confirmed for filing by the U.S. Food and Drug Administration (FDA), which means that the application, submitted in July of this year, is sufficiently complete to permit a substantive review. The company also announced that its Marketing Authorization Application (MAA) for OMS302, submitted last month, has been validated by the European Medicines Agency (EMA). Validation of the MAA confirms that the submission package is administratively complete and is ready for formal review by Europe's Committee for Medicinal Products for Human Use (CHMP). Omeros is seeking approval of OMS302 for use during intraocular lens replacement (ILR) surgery for the maintenance of intraoperative mydriasis (pupil dilation), prevention of intraoperative miosis (pupil constriction), and reduction of postoperative ocular pain. The NDA will undergo FDA's standard review, and the MAA has been designated for EMA's centralized procedure in which a recommendation for approval by CHMP would cover approval for marketing of OMS302 across all European Union Member States and other countries in the European Economic Area. "The acceptance for filing of our