Nov. 8, 2012
/PRNewswire/ -- 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
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:
About Omeros' OMS302 Program
- 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.
OMS302 is Omeros' product being developed for use during intraocular lens replacement (ILR) surgery, including cataract surgery and refractive lens exchange. OMS302 is a proprietary combination of ketorolac, an anti-inflammatory agent, and phenylephrine, a mydriatic (pupil dilating) agent. FDA-approved drugs containing each of these agents have been used in ophthalmological clinical practice for more than 15 years, and both are contained in generic, FDA-approved drugs.
ILR surgery involves replacement of the original lens of the eye with an artificial intraocular lens. These procedures are typically performed to replace a lens opacified by a cataract or to correct a refractive error of the lens (i.e., refractive lens exchange). OMS302 is added to standard irrigation solution used in ILR surgery and delivered intracamerally to maintain intraoperative mydriasis (pupil dilation), to prevent surgically induced miosis (pupil constriction), and to reduce postoperative pain and irritation. Maintenance of mydriasis is critical to the safety and surgical ease of the procedure. Intraoperative pupil constriction increases the risk of injury to intraocular structures and can substantially prolong surgical time.