SEATTLE, May 22, 2015 /PRNewswire/ -- Omeros
Corporation (NASDAQ: OMER), a biopharmaceutical company committed
to discovering, developing and commercializing small-molecule and
protein therapeutics for both large-market as well as orphan
indications targeting inflammation, coagulopathies and disorders of
the central nervous system, today announced that the European
Medicines Agency's (EMA's) Committee for Medicinal Products for
Human Use (CHMP) has adopted a positive opinion for
Omidria® (phenylephrine and ketorolac injection)
1%/0.3%. Omidria is used during cataract surgery and other
intraocular lens (IOL) replacement procedures to maintain mydriasis
(pupil dilation), prevent miosis (pupil constriction), and reduce
postoperative eye pain. Cataract surgery and IOL 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.
The positive opinion adopted for Omidria by CHMP was supported
unanimously by committee members and represents an intermediate
step toward patient access to Omidria in Europe. No post-marketing follow-up studies or
measures were recommended by CHMP for Omidria. Next, the CHMP
opinion will be reviewed by the European Commission (EC), and the
decision by the EC on approval of Omidria will be applicable to all
European Union member states plus Iceland, Lichtenstein, and Norway. The EC decision is due approximately
two months following CHMP's opinion. Decisions about price and
reimbursement for Omidria occur on a country-by-country basis.
Omidria was approved by the U.S. Food and Drug Administration in
2014 and last month was made broadly available nationwide for
commercial use. The company has received strongly positive feedback
from ophthalmic surgeons, the product being used in cataract and
IOL replacement surgery both with and without femtosecond laser and
in routine as well as complicated cases, including those with
intraoperative floppy iris syndrome (IFIS) and pseudoexfoliation, a
common cause of glaucoma. Reimbursement for Omidria has been
confirmed across each of the U.S. Medicare Administrative
Contractor regions.
"We are pleased that CHMP unanimously endorsed the benefits of
Omidria for both ophthalmic surgeons and their patients in
Europe," stated Gregory A. Demopulos, M.D., chairman and chief
executive officer of Omeros. "Omeros controls the worldwide rights
to Omidria, and our independent product launch in the U.S. is
progressing nicely. For Omidria in Europe, we plan to partner for marketing and
distribution, and we look forward to the European Commission's
decision in July."
About 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 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. 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.
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 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 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.
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SOURCE Omeros Corporation