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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