Omeros Announces FDA Acceptance of Omidria™ as Proprietary Name for OMS302
-- European Medicines Agency Review of Proposed Names to be Completed Soon --
SEATTLE, Nov. 20, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today reported that the U.S. Food and Drug Administration (FDA) accepted the proposed brand name Omidria™ for OMS302, the Company's proprietary product in development for use in intraoperative lens replacement (ILR) surgery. FDA's acceptance of the proprietary brand name is subject to the Agency's final determination prior to any approval of the product's New Drug Application (NDA) and market launch, expected in 2014. Omeros earlier received allowance of the trademark application for Omidria from the U.S. Patent and Trademark Office.
The FDA reviews proposed proprietary names, taking into account potential for confusion between the proposed name and the names of marketed drugs and pending products for which marketing applications are currently under review. The brand name Omidria was also submitted to the European Medicines Agency (EMA), with a decision anticipated later this year. Omeros recently registered Omidria as a European Community Trade Mark.
"Throughout branding analyses conducted with ophthalmic surgeons and nurses using both regulatory and marketing criteria, Omidria scored very high globally – across the US, Canada, Europe and Asia as well as in Mexico and South America," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "With FDA's acceptance, we can now accelerate the development of the Omidria brand in preparation for the product's anticipated market launch in 2014."
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' NDA for OMS302 has been accepted for filing by the FDA and its MAA for OMS302 has been validated by the EMA.
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 reduce 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 small-molecule and protein therapeutics targeting inflammation, coagulopathies and disorders of the central nervous system. Derived from its proprietary PharmacoSurgery® platform, the Company's lead drug product, OMS302 for lens replacement surgery, is currently under review for marketing approval by both the US Food and Drug Administration and the European Medicines Agency with commercial launch planned for 2014. Omeros' five other clinical programs are focused on schizophrenia, Huntington's disease and cognitive impairment; addictive and compulsive disorders; complement-related diseases; and preventing problems associated with surgical procedures. Omeros also has a proprietary GPCR platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the "safe harbor" created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" and similar expressions. 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, risks associated with Omeros' unproven preclinical and clinical development activities, regulatory oversight, product commercialization, intellectual property claims and 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 November 7, 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, even if new information becomes available in the future.
SOURCE Omeros Corporation
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