Omeros Corporation Announces Completion of Patient Enrollment in Pediatric Trial of OMIDRIA®

SEATTLE–(BUSINESS WIRE)–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.