SEATTLE, Oct. 30, 2014 /PRNewswire/ -- Omeros Corporation
(NASDAQ: OMER) announced today that it has received transitional
pass-through status for its lead product Omidria™
(phenylephrine and ketorolac injection) 1%/0.3% from the Center for
Medicare & Medicaid Services (CMS), the federal agency that
administers the Medicare program. Approved earlier this year by the
U.S. Food and Drug Administration (FDA) for use during cataract
surgery or intraocular lens replacement (ILR), Omidria is the only
FDA-approved product for intraocular administration that prevents
intraoperative miosis (pupil constriction) and reduces
postoperative pain, providing consistent and predictable management
of these problems for ophthalmic surgeons and their patients. A
large and growing market, cataract and other ILR procedures are
among the most common surgical procedures performed in the U.S.
with approximately four million expected in 2015.
Transitional pass-through status will allow ambulatory surgery
centers and other outpatient facilities to bill Medicare and other
insurance providers for Omidria using a temporary Healthcare Common
Procedure Coding System (HCPCS) code unique to Omidria.
Pass‑through status allows for separate payment for new drugs and
other medical technologies that meet specific clinical-value and
cost requirements. Pass‑through remains in effect for a period of
two to three years, after which time CMS and other insurance
providers make a new reimbursement determination. Pass‑through
status for Omidria will become effective on January 1, 2015, and reimbursement will be based
on the product's wholesale acquisition cost of between $400 and $500 per single-use vial.
"We are pleased with CMS's decision to grant pass-through for
Omidria," said Gregory A. Demopulos,
M.D., chairman and chief executive officer of Omeros. "Pass-through
status should streamline the billing and reimbursement process for
facilities that use Omidria and could accelerate adoption of the
product across cataract and other intraocular lens procedures.
Coincident with this new clarity on reimbursement, our commercial
team is in the process of adding the second wave of sales
representatives, and we plan to launch Omidria no later than early
2015."
About Omidria™
Omeros'
PharmacoSurgery® product Omidria™ (pronounced
oh-MID-ree-uh) is a proprietary combination of the mydriatic
(pupil-dilating) agent phenylephrine and the anti-inflammatory
agent ketorolac, which was developed for use during cataract or
other intraocular lens replacement (ILR) surgery. The FDA has
approved Omidria (phenylephrine and ketorolac injection) 1%/0.3%
for use during cataract surgery or ILR to maintain pupil size by
preventing intraoperative miosis (pupil constriction) and to reduce
postoperative 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
diluted prior to 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. Omeros is completing
preparations for a planned U.S. product launch no later than early
2015. Omidria is currently under review for marketing approval by
the European Medicines Agency. Omeros also has six clinical-stage
development programs focused on complement-related thrombotic
microangiopathies, Huntington's disease, schizophrenia, and
cognitive impairment; on addictive and compulsive disorders; and on
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.
Forward-Looking Statements
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 effectiveness
of Omidria™ sales and marketing efforts, Omidria market
acceptance, product pricing and reimbursement, 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 Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission on August 11, 2014. 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