Omeros Reports OMS103HP Phase 3 Clinical Trial Results

            Omeros Reports OMS103HP Phase 3 Clinical Trial Results

-- Second Meniscectomy Phase 3 Clinical Trial Enrollment Targeted for First
Half of 2013 --

-- Company to Host Conference Call Today at 5:00 p.m. EST --

PR Newswire

SEATTLE, Dec. 27, 2012

SEATTLE, Dec. 27, 2012 /PRNewswire/ --Omeros Corporation (NASDAQ: OMER) today
reported results from its first pivotal Phase 3 clinical trial evaluating
OMS103HP in patients undergoing arthroscopic partial meniscectomy surgery. In
this multicenter, double-blind, Phase 3 clinical trial comparing OMS103HP to
vehicle control in 344 subjects, the pre-specified primary endpoint was the
Symptoms Subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) –
a patient-reported measure that is comprised of questions about knee swelling,
clicking, catching and stiffness. In addition, pain measured in the early
postoperative period was a pre-specified secondary endpoint. Although the
Symptoms Subscale of the KOOS did not reach statistical significance, OMS103HP
achieved statistically significant (p=0.0003) reduction of postoperative pain.
The pain reduction data were similar in magnitude to those in the Phase 2
clinical trial. OMS103HP also demonstrated improvement across a series of
pain-related assessments including postoperative narcotic usage (with more
than twice as many OMS103HP-treated subjects taking no postoperative
narcotics), incidence of inflammatory adverse events, tourniquet use, and
crutch use as well as time to discontinuation of crutches and return to work,
a number of which also achieved statistical significance. In this study, as in
the earlier clinical trials, OMS103HP was well tolerated. Given the strength
and consistency of the data in this Phase 3 clinical trial, Omeros' second
OMS103HP Phase 3 trial remains on track and will begin in the first half of
2013.

"The data from this Phase 3 trial are compelling and demonstrate the benefits
of preemptive and multimodal treatment during surgery," stated William E.
Garrett, Jr., M.D., Ph.D, professor of orthopaedic surgery and team physician
at Duke University. "Early postoperative pain is predominantly inflammatory
pain, and control of postoperative pain and inflammation is critical to
functional recovery in arthroscopy patients. While OMS103HP demonstrated
positive KOOS data in the Phase 2 trial, the absence of similar data in this
trial does not detract from the drug's therapeutic value in light of its
reduction of inflammatory pain. Arthroscopy patients with significant early
postoperative pain and inflammation generally face a slower and more difficult
recovery."

OMS103HP, added to standard irrigation solution used during arthroscopy, is
Omeros' proprietary PharmacoSurgery™ product designed to provide a multimodal
approach to reduce pain and inflammation following arthroscopic surgery.
Inhibiting inflammation and resultant postoperative pain is critical to the
management of arthroscopy patients. Comprised of only anti-inflammatory active
ingredients without any anesthetic agents, such as lidocaine or bupivacaine,
and delivered directly to the joint in the arthroscopic irrigation solution,
use of OMS103HP avoids the frequently reported damage to cartilage cells due
to intraarticular delivery of local anesthetics as well as the detrimental
effects of systemically delivered analgesics.

"These consistent results – better pain reduction together with less narcotic
usage and less frequent incidence of postoperative inflammatory problems –
underscore the strength of OMS103HP's unique approach to improving arthroscopy
outcomes," stated Christopher C. Kaeding, M.D., professor of orthopedic
surgery and head team physician at The Ohio State University. "Orthopedic
surgeons understand the importance of preventing postoperative pain and
inflammation, and there is increasing evidence that intraoperative joint
inflammation is detrimental to the long-term health of the joint. Treatments
currently available to us, however, are administered after the surgical
insult. OMS103HP, delivered intraoperatively, provides an opportunity to
inhibit inflammation and related surgical problems before they begin. OMS103HP
could become a key component in the management of arthroscopy patients."

Results from this first Phase 3 arthroscopic meniscectomy clinical trial are
expected to be presented at an upcoming major orthopedic sports medicine
meeting. Omeros also plans to publish the results in a leading peer-reviewed
arthroscopy journal.

"We are pleased with the outcome of this trial," said Gregory A. Demopulos,
M.D., chairman and chief executive officer of Omeros. "While not meeting all
endpoints, the consistently positive results on pain reduction and the series
of related inflammatory measures mark a clear path to approval of OMS103HP.
The arthroscopy market is large and these data, together with an early 2013
NDA submission for our ophthalmic surgery product OMS302, set the stage for
potentially two near-term market launches."

About Omeros' OMS103HP Program
OMS103HP is Omeros' PharmacoSurgery™ product candidate being developed for use
during arthroscopic procedures, including partial meniscectomy surgery, and
was designed to provide a multimodal approach to preemptively block the
inflammatory cascade induced by arthroscopy. OMS103HP is a proprietary
combination of anti-inflammatory/analgesic active pharmaceutical ingredients
(APIs), each with well-known safety and pharmacologic profiles. Comprised of
only anti-inflammatory active ingredients without any anesthetic agents, such
as lidocaine or bupivacaine, and delivered directly to the joint in the
arthroscopic irrigation solution, use of OMS103HP avoids the frequently
reported damage to cartilage cells due to intraarticular delivery of local
anesthetics as well as the detrimental effects of systemically delivered
analgesics. Each of the APIs in OMS103HP are components of generic,
FDA-approved drugs that have been marketed in the United States as
over-the-counter or prescription drug products for over 15 years and have
established and well-characterized safety profiles.

Control of postoperative inflammation and resultant pain is critical to
functional recovery in arthroscopy patients. In Phase 2 and Phase 3 clinical
trials that evaluated OMS103HP in patients undergoing partial meniscectomy
surgery, OMS103HP provided clinically meaningful benefits related to
postoperative pain and inflammation.

About Arthroscopy and Arthroscopic Meniscectomy Surgery
Arthroscopy is a minimally invasive surgical procedure in which a miniature
camera lens is inserted into an anatomic joint, such as the knee, through a
small incision in the skin. Through similar incisions, surgical instruments
are also introduced and manipulated within the joint. Arthroscopic
meniscectomy is used to treat a torn meniscus cartilage in the knee. Only the
torn segment of the meniscus is removed. Postoperative recovery to normal
function may take months and, in good part, is a function of postoperative
pain and inflammation. In 2012, over four million arthroscopic procedures were
performed in the United States and over eight million globally.

Conference Call and Webcast Today at 5:00 p.m. EST
Omeros management will host a conference call today, December 27, at 5:00 p.m.
EST to discuss today's news. To access the live call by telephone, please
dial 800-510-9661 (United States and Canada) or 617-614-3452 (International).
The passcode is 97319538. In addition, the live conference call will be
webcast and can be accessed on the "Events" page of the Company's website at
http://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 starting at 7:00
p.m. EST today, which can be accessed by dialing 888-286-8010 (United States
and Canada) or 617-801-6888 (International) and entering passcode 48248130.

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 five 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 as defined within the
Private Securities Litigation Reform Act of 1995, which are subject to the
"safe harbor" created by those sections. These statements include, but are not
limited to, Omeros' expectations that it will begin enrolling the second
OMS103HP Phase 3 clinical trial in the first half of 2013; the potential
benefits of OMS103HP; that data from the first Phase 3 clinical trial will be
presented at a meeting and published in a journal; the potential marketing
approval and commercial launch timelines for OMS302 and OMS103HP; 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 November 9, 2012. 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

Website: http://www.omeros.com
Contact: Jennifer Cook Williams, Cook Williams Communications, Inc., Investor
and Media Relations, +1-360-668-3701, jennifer@cwcomm.org
 
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