Disclosure of Omidria Post-Launch Study Findings to Occur at Hawaiian Eye and Retina Conference
January 15 2016 - 11:23PM
Business Wire
Omeros Corporation (NASDAQ: OMER), a biopharmaceutical company
committed to discovering, developing and commercializing
small-molecule and protein therapeutics for both large-market as
well as orphan indications targeting inflammation, coagulopathies
and disorders of the central nervous system, today announced that
Omidria® (phenylephrine and ketorolac injection) 1% / 0.3% will be
the focus of a series of presentations and panel discussions by
thought leaders in cataract surgery at Hawaiian Eye and Retina, an
annual conference of over 1,200 ophthalmologists, retina
specialists, nurses, allied health professionals and
administrators. The first of these presentations and discussions
will occur on Sunday, January 17, 2016, at which time certain
information regarding Omidria will be made public. To ensure that
developments regarding Omeros’ business are publicly disseminated
to securities markets in consistent fashion, Omeros is announcing
that the information to be presented at the conference includes a
summary of investigator-sponsored studies, which have resulted in
abstracts and manuscripts accepted, submitted or in preparation,
reporting that the use of Omidria across a wide range of patients,
including those with non-complex cataracts, complex cataracts,
intraoperative floppy iris syndrome (IFIS) and/or
pseudoexfoliation, has resulted in statistically significant:
- reduction in complications associated
with small pupils;
- reduction in usage of pupil-expanding
devices;
- prevention of miosis during femtosecond
laser-assisted surgery;
- reduction in age-adjusted surgical
times; and
- improvement in best corrected visual
acuity (BCVA) on the day after surgery.
The above outcomes are not referenced in the currently approved
labeling for Omidria. Omidria is broadly indicated for use in
cataract surgery in adult patients.
The above findings are from investigator-sponsored,
case-controlled/cohort, single-center studies, ranging from
approximately 50 to over 1,100 patients, and have not yet been
published. Omeros’ earlier Phase 3 clinical trials evaluating
Omidria were not powered to demonstrate statistical differences in
surgical times and BCVA, and results from those Phase 3 trials did
not reach statistical significance for those measurements.
Complication rates and use of pupil-expanding devices were not
assessed in the Phase 3 trials, and femtosecond laser cases were
excluded for purposes of standardization given that not all
investigators in the Omidria Phase 3 program used this equipment in
cataract surgery. Consistent with publication guidelines, detailed
data from these investigator-sponsored studies will be available in
the published abstracts and journal articles.
About Omidria®
Omeros’ PharmacoSurgery® product Omidria® contains the mydriatic
(pupil-dilating) agent phenylephrine and the anti-inflammatory
agent ketorolac and was developed for use during cataract or other
IOL replacement surgery. The FDA has approved Omidria for use
during cataract surgery or IOL replacement to maintain pupil size
by preventing intraoperative miosis (pupil constriction) and to
reduce postoperative ocular pain.
Important Risk 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 to 24 percent 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. Omidria is not approved for use in children.
About Omeros Corporation
Omeros is a biopharmaceutical company committed to discovering,
developing and commercializing both small-molecule and protein
therapeutics for large-market as well as orphan indications
targeting inflammation, coagulopathies and disorders of the central
nervous system. Derived from its proprietary PharmacoSurgery®
platform, the company’s first drug product, Omidria® (phenylephrine
and ketorolac injection) 1%/0.3%, has been approved by the FDA 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 (EC) has approved Omidria
for use in cataract surgery and lens replacement procedures to
maintain mydriasis (pupil dilation), prevent miosis (pupil
constriction), and to reduce postoperative eye pain. Omeros has
five clinical-stage development programs focused on:
complement-related thrombotic microangiopathies; Huntington’s
disease, schizophrenia, and cognitive impairment; addictive and
compulsive disorders; and preventing problems associated with
urologic surgical procedures. In addition, Omeros has a proprietary
GPCR platform, which is making available an unprecedented number of
new GPCR drug targets and corresponding compounds to the
pharmaceutical industry for drug development.
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,” “look forward to,” “may,” “plan,” “potential,”
“predict,” “project,” “should,” “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 including with respect to Omidria® and OMS103,
Omeros’ ability to partner and commercialize Omidria® in Europe,
Omeros’ 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
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission on November 9, 2015. 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: http://www.businesswire.com/news/home/20160115005962/en/
Cook Williams Communications, Inc.Jennifer Cook Williams,
360-668-3701Investor and Media Relationsjennifer@cwcomm.org
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