SEATTLE, April 25, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today reported analyses of Phase 2 and Phase 3 clinical data showing the favorable impact of OMS302 on reducing the incidence of miosis (pupil constriction) during intraocular lens replacement (ILR). OMS302, which contains a mydriatic (pupil-dilating) agent and an anti-inflammatory agent, is the Company's product being developed for use during ILR, including cataract surgery and refractive lens exchange. These analyses were presented on April 21 at the Annual American Society of Cataract and Refractive Surgery (ASCRS) and American Society of Ophthalmic Administrators (ASOA) Symposium and Congress in San Francisco.
The clinical data presented at the ASCRS meeting show that, in the setting of all treatment- and control-group patients receiving standard-of-care preoperative mydriatic topical drops, OMS302 reduces the occurrence of pupil constriction of 2.5 mm or more and the incidence of the pupil constricting to less than 6 mm in diameter throughout surgery. These two measures are widely recognized by ophthalmologic surgeons as important for successful ILR procedures.
"Intraoperative miosis is a challenge to all lens replacement procedures, increasing both surgical time and the risk of an unsuccessful outcome," stated Eric B. Donnenfeld, M.D., clinical professor of ophthalmology at New York University and newly elected president of the ASCRS. "These data show that OMS302 successfully addresses this challenge. Given the well-recognized need for a product like OMS302 in lens replacement procedures, I expect that it will be widely and rapidly adopted by ophthalmologic surgeons."
"The strong reception that OMS302 received from the thought leaders at the ASCRS and ASOA Congress was gratifying," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "When presented with the data package for OMS302, ophthalmologic surgeons uniformly appreciate the product's benefits and expect that it will become an important part of standard practice for intraocular lens replacement. We look forward to making OMS302 available to surgeons and their patients."
About Omeros' OMS302 Program
OMS302 is Omeros' product being developed for use during intraocular lens replacement (ILR), including cataract surgery and refractive lens exchange. OMS302 is a proprietary combination of the mydriatic (pupil dilating) agent phenylephrine and the anti-inflammatory agent ketorolac. Omeros recently completed its successful OMS302 Phase 3 clinical program and expects to submit a New Drug Application to the U.S. Food and Drug Administration this quarter and a Marketing Authorization Application to the European Medicines Agency in mid-2013.
ILR 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 and delivered within the eye 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 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, OMS302 for lens replacement surgery and OMS103HP for arthroscopy, 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 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 marketing applications for OMS302; and that Omeros 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 18, 2013. 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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