Healthcare Industry News: Fagron
News Release - August 3, 2015
Omidria(R) Approved for Commercialization Throughout the European Union and Additional CountriesApproval by the European Commission Follows Unanimous Recommendation by the EMA
SEATTLE, Aug. 3, 2015 -- (Healthcare Sales & Marketing Network) -- Omeros Corporation (OMER) today announced that the European Commission (EC) has granted marketing authorization for Omidria (phenylephrine and ketorolac injection) 1% / 0.3% in the European Union (EU) for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain. This approval allows for the marketing of Omidria in all EU member states plus Iceland, Lichtenstein, and Norway. Cataract surgery and lens replacement are among the most common surgical procedures worldwide, with approximately 3.9 million of them expected to be performed in Western Europe alone in 2015.
"European ophthalmic surgeons are excited by the approval of Omidria in the EU," said Roberto Bellucci, MD, professor of ophthalmology at the University of Verona, Italy, director of the Ophthalmic Unit at the Hospital of Verona, and current president of the European Society for Cataract and Refractive Surgeons. "For the first time, we will have a product that provides consistent and predictable management of intraoperative miosis - a problem that can be challenging for surgeons. I expect that use of Omidria will translate into better outcomes for our patients and, together with the drug's ability to reduce postoperative pain, will improve patient satisfaction following cataract surgery."
Approval in the EU is based on the same clinical data that were the basis for the U.S. approval received from the U.S. Food and Drug Administration last year and follows the previously reported unanimous positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use. Decisions about price and reimbursement for Omidria occur on a country-by-country basis.
"We are pleased with the European Commission's decision to allow commercialization of Omidria throughout the EU and other European countries," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "We have developed strong thought-leader support across Europe and, building on the growing success of Omidria in the U.S., we expect the product to be well received by European cataract surgeons."
Omeros' PharmacoSurgery® product Omidria® contains the mydriatic (pupil-dilating) agent phenylephrine and the anti-inflammatory agent ketorolac and was developed for use during cataract or other IOL replacement surgery. The FDA has approved Omidria for use during cataract surgery or IOL replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain.
Important Risk Information for Omidria®
Systemic exposure of phenylephrine may cause elevations in blood pressure. In clinical trials, the most common reported ocular adverse reactions at two to 24 percent are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation; incidence of adverse events was similar between placebo-treated and Omidria-treated patients. Omidria® must be added to irrigation solution prior to intraocular use. Omidria is not approved for use in children.
About Omeros Corporation
Omeros is a biopharmaceutical company committed to discovering, developing and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system. Derived from its proprietary PharmacoSurgery® platform, the company's first drug product, Omidria® (phenylephrine and ketorolac injection) 1%/0.3%, has been approved by the FDA for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the EU, the European Commission (EC) has approved Omidria for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain. Omeros also recently partnered its arthroscopic product, OMS103, for commercialization with Fagron Sterile Services and affiliated JCB Laboratories. Omeros has five clinical-stage development programs focused on: complement-related thrombotic microangiopathies; Huntington's disease, schizophrenia, and cognitive impairment; addictive and compulsive disorders; and preventing problems associated with surgical procedures. In addition, Omeros 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," "look forward to," "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' ability to partner and commercialize Omidria® in Europe, Omeros' unproven preclinical and clinical development activities, regulatory oversight, product commercialization, intellectual property claims, competitive developments, litigation, 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 May 11, 2015. 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 Corp
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