Omeros Corporation (NASDAQ: OMER) today reported that it will present data from its first pivotal Phase 3 clinical trial evaluating OMS302 at the American Academy of Ophthalmology (AAO) Annual Meeting, which will take place from November 10 through November 13 in Chicago, Illinois.
OMS302, added to standard irrigation solution used during ophthalmological procedures, is Omeros' proprietary PharmacoSurgery™ product designed to maintain intraoperative mydriasis and reduce postoperative pain and irritation resulting from cataract and other lens replacement surgery. Omeros announced earlier this week that OMS302 met its co-primary endpoints in its second pivotal Phase 3 clinical trial. Now with positive data from both trials in the OMS302 Phase 3 clinical program, Omeros' objective is to submit a New Drug Application (NDA) with the U.S. Food and Drug Administration in the first quarter of 2013 and a Marketing Authorization Application (MAA) with the European Medicines Agency in mid-2013.
The AAO presentation information is as follows:
Abstract Title: "A Phase 3 Clinical Trial of the Drug Product OMS302 Delivered Intracamerally in BSS During IOL Replacement Surgery."
Poster (#P011) to be presented on Saturday, November 10 from 9:00 a.m. to 5:00 p.m. and Sunday, November 11, 2012 from 7:30 a.m. to 5:00 p.m. in Hall A. Steve Whitaker, M.D., Omeros' vice president, clinical development and chief medical officer, will attend the poster presentation on Sunday from 12:30 p.m. to 2:00 p.m.