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Omeros Reports Allowance of Additional Patent for Ophthalmology Product OMS302
Thursday, March 29, 2012
Seattle, WA -- Omeros Corporation today reported the allowance by the US Patent and Trademark Office (USPTO) of an additional patent claiming intraocular surgical methods of using OMS302, the Company's ophthalmological PharmacoSurgery product. The issued patent will have a term extending through July 2023. Currently in Phase 3 clinical development, OMS302 is designed to maintain intraoperative mydriasis (pupil dilation) and reduce pain in the early postoperative period in patients undergoing intraocular lens replacement surgery, including cataract surgery and refractive lens exchange.
This patent extends coverage for OMS302 and further expands Omeros' established PharmacoSurgery intellectual property portfolio. The drug product demonstrated statistically significant superiority over placebo in maintenance of intraoperative mydriasis and reduction of pain in Omeros' Phase 2b clinical trial and first Phase 3 clinical trial. These positive data played a role in the USPTO's decision. Omeros plans to begin enrolling patients next month in its second OMS302 Phase 3 clinical trial.
Omeros is building a patent portfolio for OMS302 focused on protecting both the drug product's composition and method of use. Omeros currently is preparing additional patent applications directed to OMS302 that, if allowed, would further extend its patent protection until at least 2033.
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 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 four 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, statements regarding the issuance of a patent and the filing of additional patent applications for OMS302; potential benefits of OMS302; Omeros' plans to begin enrolling patients in its second OMS302 Phase 3 clinical trial next month; 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 15, 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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