Omeros Corp. Announces Presentation of OMIDRIA® Real-World Data at Upcoming American Society of Cataract & Refractive Surger...
May 01 2019 - 8:30AM
Business Wire
Omeros Corporation (Nasdaq: OMER) today announced that the
results of an investigator-sponsored real-world study of its
FDA-approved ophthalmic drug OMIDRIA® (phenylephrine and ketorolac
intraocular solution) 1% / 0.3% will be presented at the American
Society of Cataract and Refractive Surgery – American Society of
Ophthalmic Administrators Annual Meeting to be held in San Diego
May 3-7, 2019. The presentation by Keith A. Walter, M.D., Professor
of Ophthalmology at Wake Forest University School of Medicine, is
entitled Rate of Pseudophakic Cystoid Macular Edema Using
Intraoperative and Topical NSAIDs Alone Without Steroids. The study
compares the incidence of cystoid macular edema, a
sight-threatening complication of cataract surgery, in patients
undergoing cataract surgery using OMIDRIA with postoperative NSAIDs
alone versus those using postoperative corticosteroids, in the
absence of OMIDRIA, with and without NSAIDs.
About OMIDRIA®
Omeros’ OMIDRIA® (phenylephrine and ketorolac intraocular
solution) 1% / 0.3% is the first and only FDA-approved product of
its kind and is marketed in the U.S. for use during cataract
surgery or intraocular lens replacement to maintain pupil size by
preventing intraoperative miosis (pupil constriction) and to reduce
postoperative ocular pain. OMIDRIA also is the only
NSAID-containing product FDA-approved for intraocular use. In
post-launch studies across conventional and femtosecond
laser-assisted cataract surgery, OMIDRIA has been shown (1) to be
effective in patients with intraoperative floppy iris syndrome
(IFIS), pseudoexfoliation and other ophthalmic conditions, (2) to
significantly reduce complication rates, use of pupil-expanding
devices, and surgical times, and (3) to significantly improve
uncorrected visual acuity on the first day following cataract
surgery. While OMIDRIA is broadly indicated for use in cataract
surgery, the above outcomes are not in its currently approved
labeling. Surgical time was not an endpoint in the OMIDRIA Phase 3
clinical trials and did not reach statistical significance in post
hoc analysis of the Phase 3 data.
Important Safety Information for OMIDRIA®
Systemic exposure of phenylephrine may cause elevations in blood
pressure. In clinical trials, the most common reported ocular
adverse reactions at two percent or greater are eye irritation,
posterior capsule opacification, increased intraocular pressure,
and anterior chamber inflammation; incidence of adverse events was
similar between placebo-treated and OMIDRIA-treated patients.
OMIDRIA must be added to irrigation solution prior to intraocular
use.
About Omeros Corporation
Omeros is a commercial-stage biopharmaceutical company
committed to discovering, developing and commercializing
small-molecule and protein therapeutics for large-market as well as
orphan indications targeting inflammation, complement-mediated
diseases, disorders of the central nervous system and
immune-related diseases, including cancers. The company’s drug
product OMIDRIA® (phenylephrine and ketorolac intraocular solution)
1% / 0.3% is marketed for use during cataract surgery or
intraocular lens (IOL) replacement to maintain pupil size by
preventing intraoperative miosis (pupil constriction) and to reduce
postoperative ocular pain. In the European Union,
the European Commission has approved OMIDRIA for use in
cataract surgery and other IOL replacement procedures to maintain
mydriasis (pupil dilation), prevent miosis (pupil constriction),
and to reduce postoperative eye pain. Omeros has multiple
Phase 3 and Phase 2 clinical-stage development programs focused on:
complement-associated thrombotic microangiopathies;
complement-mediated glomerulonephropathies; cognitive impairment;
and addictive and compulsive disorders. In
addition, Omeros has a diverse group of preclinical
programs and a proprietary G protein-coupled receptor (GPCR)
platform through which it controls 54 new GPCR drug targets and
corresponding compounds, a number of which are in preclinical
development. The company also exclusively possesses a novel
antibody-generating platform.
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. All statements other than statements of historical fact
are forward-looking statements, which are often indicated by terms
such as “anticipate,” “believe,” “could,” “estimate,” “expect,”
“goal,” “intend,” “likely”, “look forward to,” “may,” “plan,”
“potential,” “predict,” “project,” “prospects,” “should,” “slated,”
“targeting,” “will,” “would” and similar expressions and variations
thereof. 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, risks associated with product commercialization and
commercial operations, unproven preclinical and clinical
development activities, regulatory oversight, intellectual property
claims, competitive developments, litigation, and the risks,
uncertainties and other factors described under the heading “Risk
Factors” in the company’s Annual Report on Form 10-K filed with
the Securities and Exchange Commission on March 1,
2019. 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, even if new information becomes
available in the future.
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version on businesswire.com: https://www.businesswire.com/news/home/20190501005412/en/
Cook Williams Communications, Inc.Jennifer Cook Williams,
360-668-3701Investor and Media Relationsjennifer@cwcomm.org
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