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Omeros Submits OMS302 Marketing Authorization Application to European Medicines Agency

    Omeros Submits OMS302 Marketing Authorization Application to European
                               Medicines Agency

- European Market Launch Planned for Second Half of 2014 -

PR Newswire

SEATTLE, Sept. 10, 2013

SEATTLE, Sept. 10, 2013 /PRNewswire/ --Omeros Corporation (NASDAQ:
OMER)today announced that it recently submitted a Marketing Authorization
Application (MAA) to the European Medicines Agency (EMA) seeking approval to
market OMS302 for use in patients undergoing intraocular lens replacement
(ILR) surgery in the European Union (EU). Added to standard irrigation
solution used during ILR, OMS302 is Omeros' proprietary PharmacoSurgery®
product that, across multiple human trials, demonstrated clinically meaningful
and statistically significant maintenance of intraoperative mydriasis (pupil
dilation), prevention of intraoperative miosis (pupil constriction), and
reduction of postoperative ocular pain.

With the submission by Omeros of a New Drug Application (NDA) for OMS302 to
the U.S. Food and Drug Administration (FDA) in July 2013, the MAA represents
Omeros' second major submission seeking regulatory authorization to market
OMS302. The EMA previously granted OMS302 eligibility for centralized review,
determining that the product represents a significant therapeutic innovation.
The MAA for OMS302, therefore, was submitted through EMA's Centralized
Procedure, which allows submission of a single application that, when
approved, authorizes the drug to be marketed in all EU member states and
European Free Trade Association countries rather than requiring separate
national approvals. The NDA and MAA are each subject to an initial evaluation
prior to commencement of the formal review process. Assuming successful
completion of the review process and approval of the NDA and MAA, OMS302 is
expected to be available to ophthalmic surgeons and their patients in the U.S.
and Europe in the second half of 2014.

"Having submitted two major marketing applications just weeks apart for our
lead product is an outstanding achievement," said Gregory A. Demopulos, M.D.,
chairman and chief executive officer of Omeros. "Omeros' commercialization
activities in anticipation of 2014 launches in both the U.S. and Europe are
well underway, and we look forward to making OMS302 available to surgeons and
their patients."

About Omeros' OMS302 Program
OMS302 is Omeros' product being developed for use during intraocular lens
replacement, including cataract surgery and refractive lens exchange. OMS302
is a proprietary combination of the mydriatic (pupil dilating) agent
phenylephrine and the anti-inflammatory agent ketorolac. Omeros submitted an
NDA to the FDA in July 2013 and recently submitted an MAA to the EMA.

ILR involves replacement of the original lens of the eye with an artificial
intraocular 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). OMS302 is added to standard irrigation solution
used in ILR and delivered within the eye to maintain intraoperative mydriasis
(pupil dilation), to reduce surgically induced miosis (pupil constriction),
and to reduce postoperative pain and irritation. Maintenance of mydriasis is
critical to the safety and surgical ease of the procedure. Intraoperative
pupil constriction increases the risk of injury to intraocular structures and
can substantially prolong surgical time.

About Omeros Corporation
Omeros is a clinical-stage biopharmaceutical company committed to discovering,
developing and commercializing products targeting inflammation, coagulopathies
and disorders of the central nervous system. The Company's most clinically
advanced product candidates, OMS302 for lens replacement surgery and OMS103HP
for arthroscopy, are derived from its proprietary PharmacoSurgery™ platform
designed to improve clinical outcomes of patients undergoing a wide range of
surgical and medical procedures. Omeros has six clinical development programs.
Omeros may also have the near-term capability, through its GPCR program, to
add a large number of new drug targets and their corresponding compounds to
the market. Behind its clinical candidates and GPCR platform, Omeros is
building a diverse pipeline of protein and small-molecule preclinical programs
targeting inflammation, coagulopathies and central nervous system disorders.

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. These statements include, but are not limited
to, potential OMS302 marketing approval from the FDA and EMA; the expected
market launch of OMS302, if regulatory approval is obtained, in the United
States and Europe in 2014; the availability of OMS302 to ophthalmic surgeons
and their patients, if regulatory approval is obtained, in the United States
and Europe in the second half of 2014; and that Omeros may have capability,
through its GPCR program, to add a large number of new drug targets and their
corresponding compounds to the market. 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, 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 9, 2013. 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 publicly, even if new information becomes available
in the future.

SOURCE Omeros Corporation

Contact: Jennifer Cook Williams, Cook Williams Communications, Inc.,Investor
and Media Relations, 360.668.3701, jennifer@cwcomm.org
 
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