US & European Regulators Accept For Review Omeros'OMS302 Marketing Applications

(RTTNews) - Omeros Corp. (OMER) said the New Drug Application or NDA for its ophthalmology product, OMS302, has been confirmed for filing by the U.S. Food and Drug Administration or FDA, meaning that the application, submitted in July of this year, is sufficiently complete to permit a substantive review.

Further, the company reported that its Marketing Authorization Application or MAA for OMS302, submitted last month, has been validated by the European Medicines Agency or EMA. The MAA validation confirms that the submission package is administratively complete and is ready for formal review by Europe's Committee for Medicinal Products for Human Use or CHMP.

Omeros is seeking approval of OMS302 for use during intraocular lens replacement or ILR surgery for the maintenance of intraoperative mydriasis, prevention of intraoperative miosis, and reduction of postoperative ocular pain. The NDA would 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.

According to Gregory Demopulos, chairman and chief executive of Omeros, "The acceptance for filing of our NDA by the FDA and validation of our MAA by the EMA mark important milestones on the path toward the commercial launch of OMS302 expected in 2014."