Omeros to Present Data from Successful OMS302 Phase 3 Clinical Trial at the American Academy of Ophthalmology Annual Meeting
SEATTLE, Nov. 8, 2012 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today reported that it will present data from its first pivotal Phase 3 clinical trial evaluating OMS302 at the American Academy of Ophthalmology (AAO) Annual Meeting, which will take place from November 10 through November 13 in Chicago, Illinois.
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. Omeros announced earlier this week that OMS302 met its co-primary endpoints in its second pivotal Phase 3 clinical trial. Now with positive data from both trials in the OMS302 Phase 3 clinical program, Omeros' objective is to submit a New Drug Application (NDA) with the U.S. Food and Drug Administration in the first quarter of 2013 and a Marketing Authorization Application (MAA) with the European Medicines Agency in mid-2013.
The AAO presentation information is as follows:
Abstract Title: "A Phase 3 Clinical Trial of the Drug Product
OMS302 Delivered Intracamerally in BSS During IOL Replacement
Surgery."
Poster (#P011) to be presented on Saturday, November 10 from 9:00
a.m. to 5:00 p.m. and Sunday, November 11, 2012 from 7:30 a.m. to
5:00 p.m. in Hall A. Steve Whitaker, M.D., Omeros' vice president,
clinical development and chief medical officer, will attend the
poster presentation on Sunday from 12:30 p.m. to 2:00 p.m.
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 15 years, 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.
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; 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
CONTACT: Jennifer Cook Williams, Cook Williams Communications,
Inc., Investor and Media Relations, +1-360-668-3701, jennifer@cwcomm.org
Posted: November 2012
