Omeros Ophthalmology Product OMS302 Granted Eligibility for European Centralized Review
-- Centralized Procedure Used for Products that Represent Therapeutic Innovation --
Apr 30, 2013, 07:00 ET
SEATTLE, April 30, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that the European Medicines Agency (EMA) has confirmed that the Company's planned Marketing Authorization Application (MAA) for its ophthalmology product OMS302 can be submitted and reviewed under the EMA's centralized procedure. OMS302, which contains mydriatic (pupil-dilating) and anti-inflammatory agents, is the Company's product being developed for use during intraocular lens replacement, including cataract surgery and refractive lens exchange. EMA's Committee for Medicinal Products for Human Use granted this eligibility for OMS302 because it represents a significant therapeutic innovation.
The EMA's centralized procedure allows submission of a single MAA that, when approved, authorizes the drug to be marketed in all European Union member states and European Free Trade Association countries rather than requiring separate national approvals. The centralized process can significantly accelerate widespread commercialization in Europe. Omeros intends to submit a New Drug Application for OMS302 to the U.S. Food and Drug Administration this quarter and an MAA to European regulators in mid-2013.
"The determination that OMS302 qualifies for centralized filing underscores the product's therapeutic innovation and allows Omeros to pursue more rapid commercialization throughout Europe," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "OMS302 promises significant benefits to ophthalmic surgeons and their patients, and we look forward to launching it in the U.S. and Europe next year."
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 that it will submit marketing applications for OMS302 in 2013; that the centralized procedure will allow more rapid commercialization of OMS302 in Europe, if approved; that Omeros will begin selling OMS302 next year, if approved; 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.
SOURCE Omeros Corporation
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