SEATTLE, 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 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.
About Omeros' OMS302 Program 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.
About Ophthalmological Procedures (Cataract and Other Lens Replacement Surgery) There are 3.6 million intraocular lens replacement procedures expected in the U.S. this year and 15 million in developed countries, with a projected annual growth rate of three to four percent. There are multiple commercial opportunities within the lens replacement market, including both standard and premium lenses. The premium market includes toric, multifocal and accommodating lenses. Refractive lens exchange is also a growing segment of the lens replacement market.
About Omeros Corporation Omeros is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products targeting inflammation, coagulopathies and disorders of the central nervous system. The Company's most clinically advanced product candidates are derived from its proprietary PharmacoSurgery™ platform designed to improve clinical outcomes of patients undergoing a wide range of surgical and medical procedures. Omeros has five ongoing clinical development programs. Omeros may also have the near-term capability, through its GPCR program, to add a large number of new drug targets and their corresponding compounds to the market. Behind its clinical candidates and GPCR platform, Omeros is building a diverse pipeline of protein and small-molecule preclinical programs targeting inflammation, coagulopathies and central nervous system disorders.
Forward-Looking Statements This press release contains forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995, which are subject to the "safe harbor" created by those sections. These statements include, but are not limited to, Omeros' expectations regarding when it will submit an NDA and MAA for OMS302; and that it may have capability, through its GPCR program, to add a large number of new drug targets and their corresponding compounds to the market. Forward-looking statements are based on management's beliefs and assumptions and on information available to management only as of the date of this press release. Omeros' actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, the risks, uncertainties and other factors described under the heading "Risk Factors" in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 7, 2012. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements publicly, even if new information becomes available in the future.
SOURCE Omeros Corporation