- Cataract surgery performed using OMIDRIA had lower rates of CME
than cataract surgery using postoperative steroids-
Omeros Corporation (Nasdaq: OMER) today announced the results of a
real-world clinical study showing that its FDA-approved ophthalmic drug
OMIDRIA® (phenylephrine and ketorolac intraocular solution)
1% / 0.3% decreases the incidence of postoperative cystoid macular edema
(CME), a sight-threatening complication of cataract surgery. The study
results were presented at the joint annual meeting of the American
Society of Cataract and Refractive Surgery and American Society of
Ophthalmic Administrators held in San Diego May 3-7, 2019.
The investigator-sponsored study was conducted by Keith A. Walter, M.D.,
Professor of Ophthalmology at Wake Forest University School of Medicine.
He conducted a retrospective analysis of 504 eyes (357 patients) on whom
he had performed cataract surgery using OMIDRIA plus only a topical
non-steroidal anti-inflammatory drug (NSAID), assessing the incidence of
CME. The control group consisted of a collection of single and
meta-analytic studies published in the peer-reviewed literature in which
steroids, with and without topical NSAIDs, were used in cataract surgery
in the absence of OMIDRIA. Of the 504 eyes treated with OMIDRIA, only
two developed postoperative CME, an incidence of 0.39 percent, which is
3- to 12-fold lower than the CME rates (a range of 1.2 percent to 5
percent) in the published peer-reviewed studies using steroids both with
and without NSAIDs in the absence of OMIDRIA.
“CME can be a horrendous sight-threatening complication of cataract
surgery,” stated Dr. Walter. “To prevent CME, ophthalmic surgeons have
routinely used topical NSAIDs together with steroids. This study
confirms what we were seeing in practice – that use of OMIDRIA reduces
the incidence of CME. In fact, use of OMIDRIA with only a topical NSAID
precludes the need for steroids in cataract surgery, delivering a 3- to
12-fold decrease in the incidence of CME compared to studies in the
peer-reviewed literature using steroids with and without topical NSAIDs.
The result is not only increased convenience for the patient but, more
important, meaningfully increased safety.”
A manuscript reporting details of the study is in preparation and is
expected to be submitted for publication in a peer-reviewed journal.
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.
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.
Source: Omeros Corporation
View source version on businesswire.com: https://www.businesswire.com/news/home/20190507005620/en/
Copyright Business Wire 2019