SEATTLE, June 2, 2014 /PRNewswire/ -- Omeros Corporation
(NASDAQ: OMER) today announced that the U.S. Food and Drug
Administration (FDA) has approved Omidria™ (phenylephrine and
ketorolac injection) 1%/0.3% for use during cataract surgery or
intraocular lens replacement (ILR) to maintain pupil size by
preventing intraoperative miosis (pupil constriction) and to reduce
postoperative pain. The approval comes with no post-marketing
commitments other than the previously agreed study of Omidria for
use in pediatric patients, which, if successfully completed, makes
the drug eligible for an additional six months of marketing
exclusivity in the U.S.
Omidria, the first commercial product from Omeros'
PharmacoSurgery® platform, is a proprietary combination
of a mydriatic (pupil-dilating) agent and an anti-inflammatory
agent that is added to irrigation solution standardly used during
cataract surgery and other ILR procedures (e.g., refractive lens
exchange), collectively the most common surgical procedures
performed in the U.S. at nearly four million annually. Omidria is
the only FDA-approved product for intraocular use that prevents
intraoperative miosis and reduces postoperative pain, providing
consistent and predictable management of both of these ILR-related
problems for ophthalmic surgeons and their patients.
"Omidria is an important advance in cataract and lens
replacement surgery," stated Richard L.
Lindstrom, M.D., adjunct clinical professor emeritus at the
University of Minnesota's Department of
Ophthalmology and past president of both the American Society of
Cataract and Refractive Surgeons and the International Society of
Refractive Surgery. "Miosis and postoperative pain are frequent and
largely unpredictable, and their occurrence can make the procedure
more difficult for the surgeon and unpleasant postoperatively for
the patient. While not changing their surgical routine, the use of
Omidria will better allow ophthalmic surgeons to control the
operative experience and, I expect, will improve surgical
outcomes."
In pivotal trials in which all patients received standard
pupil-dilating and anesthetic agents prior to surgery, Omidria
demonstrated statistically significant and clinically meaningful
improvement in the prevention of miosis and reduction of
postoperative pain relative to placebo. Ocular adverse reactions in
the trials were similar between the Omidria and placebo groups and
included eye irritation, posterior capsule opacification, increased
intraocular pressure and anterior chamber inflammation.
"The approval and near-term market launch of Omidria could not
come at a better time," stated Eric B.
Donnenfeld, M.D., clinical professor of ophthalmology at
New York University and immediate-past
president of the American Society of Cataract and Refractive
Surgery. "With increasingly restrictive regulations around
compounding, surgeons are looking for a safe and effective
FDA-approved product to improve surgical outcomes by maintaining
pupil dilation during lens replacement surgery and that quickly
resolves postoperatively, potentially allowing faster recovery of
vision. In addition, the anti-inflammatory ketorolac in Omidria
could reduce the need for preoperative NSAIDs."
With FDA approval of Omidria, Omeros is completing preparations
for a late summer/early fall 2014 U.S. product launch.
"The FDA approval of Omidria is the first of what we expect will
be a long line of product approvals for Omeros given our deep
pipeline of products, many of which are currently in clinical
trials," stated Gregory A.
Demopulos, M.D., chairman and chief executive officer of
Omeros. "We have continued to round out our commercialization team
and are focused on obtaining European approval for Omidria,
securing Medicare pass-through reimbursement and successfully
launching the product in the U.S. later this year. In parallel, our
premier clinical and non-clinical programs are advancing, and we
look forward to sales of Omidria significantly defraying future
development costs of our rich pipeline."
Important Risk Information for
Omidria™
Systemic exposure of phenylephrine may
cause elevations in blood pressure. In clinical trials, the most
common reported 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 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.
About Cataract Surgery and Intraocular Lens Replacement
(ILR)
Cataract surgery and other intraocular lens
replacement (ILR) procedures involve replacement of the original or
artificial intraocular lens of the eye with a new artificial lens.
These procedures are typically performed to replace a lens
opacified by a cataract or to correct a refractive error of the
lens (i.e., refractive lens exchange).
Conference Call and Webcast Today at 4:30 p.m. Eastern Time
The Omeros
management team will host a conference call today at 4:30 p.m. Eastern Time to discuss the approval of
Omidria™. Interested parties may participate in the conference
call by dialing (866) 515-2910 (United
States and Canada) or (617)
399-5124 (International). In addition, the live conference call is
being webcast and can be accessed on the "Events" page of the
Company's website at www.omeros.com.
A replay of the webcast will be available on the Company's
website for one week. A telephone replay will also be available for
one week, which can be accessed by dialing (888) 286-8010
(United States and Canada) or (617) 801-6888 (International) and
entering conference ID number 68733741.
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
lead 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 pain. Omeros is completing preparations for
a late summer/early fall 2014 U.S. product launch. Omidria is
currently under review for marketing approval by the European
Medicines Agency. Omeros' six other clinical programs are focused
on schizophrenia, Huntington's disease and cognitive impairment;
addictive and compulsive disorders; complement-related diseases;
and 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 May 12, 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