Omeros Announces Positive OMS302 Safety Data in Phase 3 Clinical Trial
-- Market Launch Expected First Half of 2014 --
SEATTLE, Jan. 22, 2013
SEATTLE, Jan. 22, 2013 /PRNewswire/ --Omeros Corporation (NASDAQ: OMER) today
announced the successful completion of the 90-day safety database lock in the
second of the Company's two pivotal Phase 3 clinical trials evaluating OMS302
in patients undergoing intraocular lens replacement surgery. 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. In November 2012,
Omeros announced that OMS302 met the co-primary efficacy endpoints in this
second pivotal Phase 3 clinical trial 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.
This multicenter, double-blind, Phase 3 clinical trial enrolled 416 patients
randomized 1:1 to receive either OMS302 or placebo. Safety data were collected
through postoperative day 90. In this Phase 3 clinical trial, OMS302 was well
tolerated. The incidence of adverse events was similar between the two
treatment groups, and the adverse event profile was similar to that seen in
prior OMS302 clinical trials. No safety concerns have been identified in the
OMS302 clinical development program. 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.
"While these data were expected, they underscore the safety benefits of
intraoperative and local delivery of OMS302 – administration of efficacious
and low concentrations of the active ingredients directly to the surgical site
reduces systemic uptake and the probability of adverse side effects," stated
Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros.
"Together with the strong and consistent efficacy data observed throughout its
clinical development program, we believe that OMS302 represents a significant
advance in lens replacement surgery, and our NDA and MAA are progressing well.
We also expect to read out data from our OMS824 multiple-dose pharmacokinetic
clinical trial later this quarter and to begin our second OMS103HP
meniscectomy Phase 3 trial next quarter."
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
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.
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.
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 the date of the expected market
launch of OMS302, when it will read out data from is OMS824 program and begin
enrolling its second OMS103HP Phase 3 trial, the growth rate of the number of
intraocular lens replacement procedures performed annually 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
Contact: Jennifer Cook Williams, Cook Williams Communications, Inc., Investor
and Media Relations, +1-360-668-3701, email@example.com
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