SEATTLE, April 2, 2015 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER), a biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system, announced today the nationwide commercial availability of Omidria™ (phenylephrine and ketorolac injection) 1%/0.3%. Omidria is the first and only product approved by the U.S. Food and Drug Administration (FDA) for intraocular administration during cataract surgery and other intraocular lens (IOL) replacement procedures to prevent intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain, providing consistent and predictable management of these problems for ophthalmic surgeons and their patients. A large and growing market, cataract and other IOL replacement procedures are among the most common surgical procedures performed in the U.S. with approximately four million expected in 2015.
The nationwide commercial launch of Omidria follows the successful completion of a two-month controlled launch during which the product was made available to a relatively small number of ophthalmic surgeons from across the U.S. to allow for any necessary refinements in distribution, reimbursement and other commercial processes. Feedback from the participating facilities and surgeons, both with respect to clinical efficacy and commercial processes, was uniformly positive.
"My colleagues and I at Island Eye Surgical Center have now used Omidria across a wide range of cases, including complicated procedures in which we expected to be faced with intraoperative pupillary constriction – Omidria performed beautifully and delivered outstanding results," stated Eric Donnenfeld, M.D., clinical professor of ophthalmology at New York University and immediate-past president of the American Society of Cataract and Refractive Surgery. "The product integrated easily into my surgical routine and, because it is FDA-approved, I don't have the concerns associated with compounded products. Patients were comfortable during and after surgery and pleased with their cataract experience. In addition, reimbursement was straightforward. Omidria represents a win-win-win for patients, ophthalmic surgeons and their facilities, and we look forward to using Omidria on all cases for which it is indicated."
Omidria was granted transitional pass-through status effective January 1, 2015 from the Center for Medicare & Medicaid Services (CMS), the federal agency that administers the Medicare program. Pass-through status allows for separate payment for new drugs and other medical technologies that meet specific clinical-value and cost requirements. Pass-through status for Omidria is expected to remain in effect until December 31, 2017, near which time CMS will evaluate utilization of Omidria and will re-assess its reimbursement status. CMS has set the reimbursement rate for Omidria under Medicare Part B at the product's wholesale acquisition cost (WAC) of $465 plus six percent per single-use vial for the second and third quarters of 2015 after which the rate will be based on average selling price (ASP) plus six percent.
"The Omeros team has worked hard and has done an outstanding job in bringing the company to this important milestone," stated Gregory A. Demopulos, M.D., chairman and chief executive officer. "Not only is this launch exciting for Omeros and our shareholders, it represents an opportunity for ophthalmic surgeons and their patients to experience firsthand the benefits of Omidria. The timing of our launch coincides nicely with the American Society of Cataract and Refractive Surgery annual meeting, and we look forward to showcasing Omidria to the thousands of anterior segment surgeons who attend the conference."
For more information on Omidria visit www.omidria.com and refer to the accompanying full prescribing information.
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 intraocular lens (IOL) replacement surgery. The FDA has approved Omidria (phenylephrine and ketorolac injection) 1%/0.3% for use during cataract surgery or IOL replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. The European Medicines Agency (EMA) is currently reviewing the Marketing Authorization Application (MAA) for Omidria.
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. 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 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 replacement (ILR) to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. Omidria is currently under review for marketing approval by the European Medicines Agency. Omeros has six 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 begin broad U.S. commercial sales of Omidria™ (OMS302) in early April 2015, Omeros' ability to obtain regulatory approval for its Marketing Authorization Application in the EU for the commercialization of Omidria, 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 16, 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 Corporation