Omeros' Ophthalmology Product OMS302 Successful in Second Phase 3 Clinical Trial

  Omeros' Ophthalmology Product OMS302 Successful in Second Phase 3 Clinical
                                    Trial

-- Submission of New Drug Application Planned for First Half of 2013--

-- Company to Host Conference Call Today at 9:00 a.m. EST--

PR Newswire

SEATTLE, Nov. 5, 2012

SEATTLE, Nov. 5, 2012 /PRNewswire/ --Omeros Corporation (NASDAQ: OMER) today
reported positive data from the second of its two pivotal Phase 3 clinical
trials evaluating OMS302 in patients undergoing intraocular lens replacement
surgery. In this second Phase 3 clinical trial comparing OMS302 to placebo,
OMS302 met its co-primary endpoints by demonstrating statistically significant
(p<0.00001) maintenance of intraoperative mydriasis (pupil dilation) and
statistically significant (p=0.0002) reduction of pain in the early
postoperative period. OMS302, added to standard irrigation solution used
during ophthalmological procedures, is Omeros' proprietary PharmacoSurgery™
product designed to maintain intraoperative mydriasis and reduce postoperative
pain and irritation resulting from cataract and other lens replacement
surgery. Now with positive data from both trials in the OMS302 Phase 3
clinical program, Omeros plans to submit a New Drug Application (NDA) with the
U.S. Food and Drug Administration in the first half of 2013 and a Marketing
Authorization Application (MAA) with the European Medicines Agency in
mid-2013, potentially allowing sales in 2014.

This multicenter, double-blind, Phase 3 clinical trial enrolled 416 patients
randomized 1:1 to receive either OMS302 or placebo. The co-primary endpoints
were maintenance of intraoperative mydriasis (pupil dilation) and reduction of
pain in the early postoperative period. Mydriasis is critical to the safety
and surgical ease of lens replacement surgery as intraoperative pupil
constriction increases the risk of injury to intraocular structures and can
substantially prolong surgical time. OMS302 also achieved statistical
significance in other clinically relevant measures. The results from this
trial are consistent with those from Omeros' first OMS302 Phase 3 and earlier
Phase 2b clinical trials.

In this study, as with the earlier clinical trials, OMS302 was well tolerated.
The final review of all safety data will occur following the last safety
assessment in January 2013. To date, no safety concerns have been identified.
Results from this study are expected to be presented at an upcoming major
ophthalmology meeting. Omeros also plans to publish the results in a leading
peer-reviewed ophthalmology journal.

"The data from this second Phase 3 trial are as compelling as those from the
first Phase 3 and earlier Phase 2b trials," stated Alan S. Crandall, M.D.,
director of glaucoma and cataract, senior vice chairman of ophthalmology and
visual sciences at the Moran Eye Center, University of Utah, and past
president of the American Society of Cataract and Refractive Surgery.
"Collectively, these data consistently and convincingly demonstrate that
OMS302 addresses two universal needs in lens replacement surgery – maintenance
of intraoperative mydriasis and management of postoperative pain. I expect
that OMS302 will represent a significant and widely used advance in the
practice of ophthalmologic surgeons who perform intraocular lens replacement,
improving both surgical ease and patient outcomes."

"As a clinical investigator in both OMS302 Phase 3 trials, I was impressed by
the substantial benefits observed in a large cohort of my patients who
participated in the studies," stated Steven H. Dunn, M.D., Fellow of the
American Academy of Ophthalmology, Houston Eye Associates. "A good number of
patients generally had better postoperative courses and greater overall
satisfaction with the entire surgical experience – both critically important
to ophthalmologic surgeons and their practices. The maintenance of pupil
diameter throughout the lens replacement surgery facilitates the technical
aspects of the procedure and, I believe, could reduce the potential for
surgical and postoperative complications."

"This successful trial marks another major milestone for Omeros, our employees
and our shareholders," said Gregory A. Demopulos, M.D., chairman and chief
executive officer of Omeros. "We are on track to submit an NDA in the first
half of 2013 and an MAA shortly thereafter, and we are continuing to build out
our commercialization plan in anticipation of a 2014 market launch. With the
anticipated arrival later this year of Phase 3 results from our OMS103HP
meniscectomy trial as well as Phase 1 data from our PDE10 program, together
with additional programs advancing into the clinic in 2013, we expect that
OMS302 will be the first of many Omeros products to improve the lives of
patients."

About Omeros' OMS302 Program
OMS302 is Omeros' product being developed for use during intraocular lens
replacement (ILR) surgery, including cataract surgery and refractive lens
exchange. OMS302 is a proprietary combination of ketorolac, an
anti-inflammatory agent, and phenylephrine, a mydriatic (pupil dilating)
agent. FDA-approved drugs containing each of these agents have been used in
ophthalmological clinical practice for more than 15years, and both are
contained in generic, FDA-approved drugs.

ILR surgery 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 surgery and delivered intracamerally to maintain
intraoperative mydriasis (pupil dilation), to prevent 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 Ophthalmological Procedures (Cataract and Other Lens Replacement
Surgery)
There are 3.6 million intraocular lens replacement procedures expected in the
U.S. this year and 15 million in developed countries, with a projected annual
growth rate of three to four percent. There are multiple commercial
opportunities within the lens replacement market, including both standard and
premium lenses. The premium market includes toric, multifocal and
accommodating lenses. Refractive lens exchange is also a growing segment of
the lens replacement market.

Conference Call and Webcast Today at 9:00 a.m. EST
Omeros management will host a conference call today, November 5, at 9:00 a.m.
EST to discuss today's news. To access the live call by telephone, please
dial 866-783-2139 (United States and Canada) or 857-350-1598 (International).
The passcode is 41699539. 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
11:00 a.m. EST today, which can be accessed by dialing 888-286-8010 (United
States and Canada) or 617-801-6888 (International) and entering passcode
47904078.

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 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 ongoing 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 regarding when it will submit an NDA and MAA
for OMS302; when sales may commence for OMS302; its publication plans for the
OMS302 clinical data; the potential use of OMS302 by ophthalmologic surgeons;
when it will announce the results from its Phase 3 OMS103HP clinical trial and
Phase 1 PDE10 clinical trial; the number of its programs that will enter the
clinic in 2013; and that it 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 7, 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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