Omeros drug ready for FDA, CHMP review

Seattle-Omeros Corp. has announced that the new drug application (NDA) for its new product, OMS302, has been confirmed for filing by the FDA.

The marketing authorization application (MAA) for the drug has also been validated by the European Medicines Agency (EMA), and is ready for formal review by Europe’s Committee for Medicinal Products for Human Use (CHMP).

Omeros is seeking approval of the drug for use during IOL replacement surgery for the maintenance of intraoperative mydriasis, prevention of intraoperative miosis, 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 recommendation for approval by CHMP would cover approval for marketing of the drug across the European Union and other countries in the European Economic Area.

“The acceptance for filing of our NDA by the FDA and validation of our MAA by the EMA mark important milestone on the path toward the commercial launch of (the drug) expected in 2014,” said Gregory A. Demopulos, MD, chairman and chief executive officer of Omeros.

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