Omeros Announces Positive OMS721 Data in Model of Age-Related Macular Degeneration

    Omeros Announces Positive OMS721 Data in Model of Age-Related Macular
                                 Degeneration

-- Ongoing Clinical Program for OMS721 Continues to Advance --

PR Newswire

SEATTLE, Nov. 5, 2013

SEATTLE, Nov. 5, 2013 /PRNewswire/ --Omeros Corporation (NASDAQ: OMER) today
announced positive data using OMS721, the lead human monoclonal antibody in
Omeros' mannan-binding lectin-associated serine protease-2 (MASP-2) program,
in a well-established animal model of neovascular age-related macular
degeneration (AMD), which is characterized by abnormal growth of new blood
vessels behind the retina of the eye and is a leading cause of vision loss in
individuals over 60 years of age. Omeros is currently completing a Phase 1
clinical trial of OMS721 in healthy subjects.

The study was conducted by Dr. Puran S. Bora and colleagues at the Jones Eye
Institute, Pat and Willard Walker Eye Research Center of the University of
Arkansas for Medical Sciences. In this animal model, new vessel growth in the
eye is induced by laser treatment. Systemically administered OMS721 resulted
in less than half of the blood vessel development compared to placebo
treatment. The study included an antibody to vascular endothelial growth
factor (VEGF) that also reduced blood vessel growth, and OMS721 outperformed
the anti-VEGF treatment. Anti-VEGF treatment is the current mainstay of
commercially available therapies for neovascular AMD.

Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting
MASP-2, a novel pro-inflammatory protein involved in activation of the
complement system – an important component of the immune system. The
complement system plays a role in the inflammatory response to tissue damage
or microbial infection, and both human genetic and animal studies have linked
the complement system to AMD development. OMS721 selectively inhibits MASP-2,
blocking the lectin pathway of the complement system while leaving intact the
classical pathway, or the acquired immune response to infection. Omeros
recently reported preclinical findings indicating that blockade of MASP-2 by
OMS721 may also have a preventive or therapeutic effect in the treatment of
thrombotic microangiopathy (TMA), a disorder that occurs in the
microcirculation (e.g., venules and capillaries) of the body's organs, most
commonly the kidney and brain.

In July of this year, Omeros began enrollment in its Phase 1 clinical program
evaluating the safety, tolerability, pharmacodynamics and pharmacokinetics of
OMS721 administered intravenously and subcutaneously in healthy subjects. A
Phase 2 clinical trial in patients suffering from TMAs, including atypical
hemolytic uremia syndrome, is planned to begin enrollment in early 2014. 

"The data from this study directly evaluating the activity of OMS721, our lead
MASP-2 inhibitor currently in a Phase 1 clinical program, further support its
potential effects in the treatment of a wide range of complement-related
diseases in humans," stated Gregory A. Demopulos, M.D., chairman and chief
executive officer of Omeros. "We look forward to reporting the results of our
Phase 1 clinical trial and the initiation of enrollment in our Phase 2
program."

About Omeros' MASP-2 Program

Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting
MASP-2, a novel pro-inflammatory protein target involved in activation of the
complement system, which is an important component of the immune system. The
complement system plays a role in the inflammatory response and becomes
activated as a result of tissue damage or microbial infection. MASP-2 appears
to be unique to, and required for the function of, one of the principal
complement activation pathways, known as the lectin pathway. Importantly,
inhibition of MASP-2 does not appear to interfere with the antibody-dependent
classical complement activation pathway, which is a critical component of the
acquired immune response to infection, and its abnormal function is associated
with a wide range of autoimmune disorders. MASP-2 is generated by the liver
and is then released into the circulation. Adult humans who are genetically
deficient in one of the proteins that activate MASP-2 do not appear to be
detrimentally affected by the deficiency. Therefore, Omeros believes that it
may be possible to deliver MASP-2 antibodies systemically and OMS721, its lead
MASP-2 antibody, is designed to be self-administered by subcutaneous
injection.

Omeros also believes that it has identified the proteins that activate the
complement system's alternative pathway in humans, which is linked to a wide
range of immune-related disorders. In addition to its lectin pathway
inhibitors, the Company is advancing the development of antibodies that would
block activation of the alternative pathway alone or in combination with the
lectin pathway.

About Omeros Corporation

Omeros is a clinical-stage biopharmaceutical company committed to discovering,
developing and commercializing small-molecule and protein therapeutics
targeting inflammation, coagulopathies and disorders of the central nervous
system. Derived from its proprietary PharmacoSurgery^® platform, the Company's
lead drug product, OMS302 for lens replacement surgery, is currently under
review for marketing approval by both the US Food and Drug Administration and
the European Medicines Agency with commercial launch planned for 2014. Omeros'
five 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. These statements include, but are not limited
to, Omeros' expectations regarding the indications and diseases that may be
treated by OMS721; the potential preventative and therapeutic effects of
OMS721; enrollment in a Phase 2 clinical trial in early 2014; and the
commercial launch of OMS302. 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. 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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