Omeros Corporation Announces Completion of Patient Enrollment in Pediatric Trial of OMIDRIA®
June 29 2016 - 7:00AM
Business Wire
-- Successful Completion Expected to Lead to
Additional Market Exclusivity --
Omeros Corporation (NASDAQ: OMER), 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, today announced that it
has completed enrollment in the post-marketing pediatric clinical
trial that is expected to provide extended market exclusivity of
its commercial product OMIDRIA® (phenylephrine and ketorolac) 1% /
0.3%. The FDA has approved OMIDRIA for use in adult patients
undergoing cataract or intraocular lens replacement surgery to
maintain pupil size by preventing intraoperative miosis (pupil
constriction) and to reduce postoperative ocular pain.
Successful completion of the pediatric clinical trial by the
company results in eligibility for an additional 6 months of
marketing exclusivity for OMIDRIA. An FDA post-marketing
requirement, the pediatric clinical trial of OMIDRIA enrolled
patients 0-3 years of age undergoing cataract surgery. Successful
completion of the trial requires compliance with FDA clinical trial
regulations and meeting pre-specified timelines. The trial is being
conducted in compliance with FDA regulations and within the
specified timelines. Similar to the Phase 3 clinical program,
efficacy assessments include pupil diameter and pain. OMIDRIA is
not yet approved for use in patients less than 18 years of age, and
the trial will provide clinical information on the use of OMIDRIA
in the pediatric population. Cataracts are relatively rare in the
pediatric population, and the sample size was selected to enable
identification of potential safety issues in the pediatric
population. Consistent with FDA’s request, over 70 patients were
enrolled and treated.
“We would like to thank the patients together with their parents
and families for their participation in this trial, and we greatly
appreciate the efforts of the investigators and other clinical site
personnel,” said Gregory A. Demopulos, M.D., chairman and chief
executive officer of Omeros. “We expect that the trial results will
provide important information on the role of OMIDRIA in pediatric
patients and look forward to submitting the data to FDA to meet the
criteria required for additional marketing exclusivity.”
About OMIDRIA®
Omeros’ OMIDRIA® (phenylephrine and ketorolac injection) 1% /
0.3% is the only FDA-approved product 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 in adults, 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 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%, was
broadly launched in the U.S. in April 2015 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 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; complement-mediated glomerulopathies;
Huntington’s disease 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, and
a platform used to generate antibodies.
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®, Omeros’
ability to partner and commercialize OMIDRIA in the Middle East and
Europe, Omeros’ unproven preclinical and clinical development
activities, regulatory oversight, intellectual property claims,
competitive developments, litigation including pending patent
litigation related to an application seeking approval from the FDA
to market a generic version of OMIDRIA, 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 May 10, 2016. 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/20160629005571/en/
Omeros Contact:Cook Williams Communications, Inc.Jennifer
Cook WilliamsInvestor and Media
Relations360.668.3701jennifer@cwcomm.org
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