SEATTLE, Nov. 5, 2012 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today reported positive data from the second of its two pivotal Phase 3 clinical trials evaluating OMS302 in patients undergoing intraocular lens replacement surgery. In this second Phase 3 clinical trial comparing OMS302 to placebo, OMS302 met its co-primary endpoints by demonstrating statistically significant (p<0.00001) maintenance of intraoperative mydriasis (pupil dilation) and statistically significant (p=0.0002) reduction of pain in the early postoperative period. 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. Now with positive data from both trials in the OMS302 Phase 3 clinical program, Omeros plans to submit a New Drug Application (NDA) with the U.S. Food and Drug Administration in the first half of 2013 and a Marketing Authorization Application (MAA) with the European Medicines Agency in mid-2013, potentially allowing sales in 2014.
This multicenter, double-blind, Phase 3 clinical trial enrolled 416 patients randomized 1:1 to receive either OMS302 or placebo. The co-primary endpoints were maintenance of intraoperative mydriasis (pupil dilation) and reduction of pain in the early postoperative period. Mydriasis is critical to the safety and surgical ease of lens replacement surgery as intraoperative pupil constriction increases the risk of injury to intraocular structures and can substantially prolong surgical time. OMS302 also achieved statistical significance in other clinically relevant measures. The results from this trial are consistent with those from Omeros' first OMS302 Phase 3 and earlier Phase 2b clinical trials.
In this study, as with the earlier clinical trials, OMS302 was well tolerated. The final review of all safety data will occur following the last safety assessment in January 2013. To date, no safety concerns have been identified. Results from this study are expected to be presented at an upcoming major ophthalmology meeting. Omeros also plans to publish the results in a leading peer-reviewed ophthalmology journal.
"The data from this second Phase 3 trial are as compelling as those from the first Phase 3 and earlier Phase 2b trials," stated Alan S. Crandall, M.D., director of glaucoma and cataract, senior vice chairman of ophthalmology and visual sciences at the Moran Eye Center, University of Utah, and past president of the American Society of Cataract and Refractive Surgery. "Collectively, these data consistently and convincingly demonstrate that OMS302 addresses two universal needs in lens replacement surgery – maintenance of intraoperative mydriasis and management of postoperative pain. I expect that OMS302 will represent a significant and widely used advance in the practice of ophthalmologic surgeons who perform intraocular lens replacement, improving both surgical ease and patient outcomes."
"As a clinical investigator in both OMS302 Phase 3 trials, I was impressed by the substantial benefits observed in a large cohort of my patients who participated in the studies," stated Steven H. Dunn, M.D., Fellow of the American Academy of Ophthalmology, Houston Eye Associates. "A good number of patients generally had better postoperative courses and greater overall satisfaction with the entire surgical experience – both critically important to ophthalmologic surgeons and their practices. The maintenance of pupil diameter throughout the lens replacement surgery facilitates the technical aspects of the procedure and, I believe, could reduce the potential for surgical and postoperative complications."
"This successful trial marks another major milestone for Omeros, our employees and our shareholders," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "We are on track to submit an NDA in the first half of 2013 and an MAA shortly thereafter, and we are continuing to build out our commercialization plan in anticipation of a 2014 market launch. With the anticipated arrival later this year of Phase 3 results from our OMS103HP meniscectomy trial as well as Phase 1 data from our PDE10 program, together with additional programs advancing into the clinic in 2013, we expect that OMS302 will be the first of many Omeros products to improve the lives of patients."
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.
Conference Call and Webcast Today at 9:00 a.m. EST
Omeros management will host a conference call today, November 5, at 9:00 a.m. EST to discuss today's news. To access the live call by telephone, please dial 866-783-2139 (United States and Canada) or 857-350-1598 (International). The passcode is 41699539. In addition, the live conference call will be webcast and can be accessed on the "Events" page of the Company's website at http://www.omeros.com.
A replay of the webcast will be available on the Company's website for one week. A telephone replay will also be available for one week starting at 11:00 a.m. EST today, which can be accessed by dialing 888-286-8010 (United States and Canada) or 617-801-6888 (International) and entering passcode 47904078.
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.
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; when sales may commence for OMS302; its publication plans for the OMS302 clinical data; the potential use of OMS302 by ophthalmologic surgeons; when it will announce the results from its Phase 3 OMS103HP clinical trial and Phase 1 PDE10 clinical trial; the number of its programs that will enter the clinic in 2013; 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.
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