SEATTLE, Oct. 15, 2015 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that it has launched OMIDRIAssure™, a comprehensive reimbursement services program to provide expanded access to Omidria® (phenylephrine and ketorolac injection) 1% / 0.3% for cataract surgery patients and reimbursement assistance for physicians and facilities. The program services include the:
- OMIDRIAssure Information Hotline for physicians and facilities seeking personalized help and information on Omidria coverage and reimbursement;
- "Equal Access" Patient Assistance Program providing assistance to financially eligible uninsured or government-insured patients; and
- "We Pay the Difference" Commercial Reimbursement Program providing assistance to patients with insufficient commercial insurance.
Omidria is the first and only FDA-approved intraocular product that both prevents intraoperative miosis and reduces postoperative ocular pain. Omidria was granted transitional pass-through reimbursement status by the Centers for Medicare and Medicaid Services (CMS) and is reimbursed by CMS separately, and in addition to, the packaged payment for cataract surgery and lens replacement procedures.
Although just recently launched, Omidria already is covered by 100 percent of Medicare Administrative Contractors and by Medicare Advantage plans at typically the same rate as Medicare Part B. The drug has confirmed coverage for 145 million of the 155 million lives insured by the top 30 U.S. commercial payers including Aetna, Cigna, Anthem/WellPoint, Humana, UnitedHealthcare and Kaiser Permanente. American Association of Retired Persons (AARP), USAA, TRICARE and a large number of Blue Cross/Blue Shield regional carriers also reimburse for Omidria.
The OMIDRIAssure coverage and reimbursement support services for surgeons and facilities remove uncertainties about coding, billing, and coverage of Omidria. The "Equal Access" Patient Assistance and the "We Pay the Difference" Commercial Reimbursement Programs remove patients' financial barriers to accessing the drug. Under the "Equal Access" program, financially eligible uninsured and government-insured patients receive Omidria free of charge for use during surgery. For commercially insured patients, Omeros through its "We Pay the Difference" program pays the facility, on behalf of the patient, the difference between the facility's acquisition cost for Omidria and the amount covered by the patient's insurance less a $30 patient responsibility.
"The clinical benefits of Omidria are clear and, together with the rapid adoption of Omidria by insurance carriers and its nearly universal coverage to date, Omidria is gaining market acceptance," stated Gregory A. Demopulos, MD, chairman and chief executive officer of Omeros. "OMIDRIAssure provides patients, physicians and facilities with further confidence that there are no financial or administrative barriers to incorporating FDA-approved Omidria across routine and complex procedures. All cataract surgery patients deserve -- and now can access -- Omidria."
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 for use during cataract surgery or IOL replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. To ensure that patients, surgeons and facilities can access the benefits of Omidria, Omeros introduced OMIDRIAssure with comprehensive reimbursement services including the "Equal Access" Patient Assistance and "We Pay the Difference" Commercial Reimbursement Programs. More information is available at www.omidriassure.com or by calling 1-877-OMIDRIA (1-877-664-3742).
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 European Union, 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 has 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 urologic 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 product commercialization including with respect to Omidria® and OMS103, Omeros' ability to partner and commercialize Omidria® in Europe, Omeros' unproven preclinical and clinical development activities, regulatory oversight, 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 August 10, 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.
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SOURCE Omeros Corporation
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