FDA, EMA to review Omeros' OMS302

Omeros Corp. (NASDAQ:OMER) said FDA and EMA accepted for review applications for OMS302 to maintain intraoperative mydriasis, prevent intraoperative miosis and reduce postoperative ocular pain in patients undergoing intraocular lens replacement surgery. The company submitted the NDA in July; a standard 10-month review would place the PDUFA date in May 2014, though a specific date is not disclosed. Omeros hopes to launch the product next year. OMS302 is a combination of the anti-inflammatory agent ketorolac and the pupil dilating agent phenylephrine. ...