-- Six-Month Extension of Patent Exclusivity and Label Expansion
Expected --
SEATTLE--(BUSINESS WIRE)--Nov. 21, 2016--
Omeros Corporation (NASDAQ: OMER) today announced the successful outcome
of its recently completed post-marketing clinical trial of the effect of
OMIDRIA® (phenylephrine and ketorolac injection) 1% / 0.3% in
pediatric patients undergoing cataract surgery. OMIDRIA is approved by
the FDA 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 and is not currently approved for use in patients less than
18 years of age.
This pediatric trial enrolled approximately 70 children aged birth
through 3 years undergoing cataract surgery. Patients received either
OMIDRIA or phenylephrine added to the irrigation solution used during
the surgical procedure. As directed by FDA and because cataracts are
relatively rare in children, the trial was powered only to detect common
adverse events and was not powered for efficacy. In the trial, OMIDRIA
was safe and well tolerated with adverse event rates consistent with
those seen in pediatric cataract surgery and similar in the OMIDRIA and
phenylephrine groups. Mean pupil diameter numerically increased
following administration of OMIDRIA. Mean postoperative pediatric pain
scores of OMIDRIA-treated patients were low (generally less than 0.5 on
a scale of 0-10) and were numerically lower in the OMIDRIA group
relative to the phenylephrine group.
The pediatric trial was undertaken as an FDA post-marketing requirement
under the Pediatric Research Equity Act and in fulfillment of FDA’s
Written Request provided under the Best Pharmaceuticals for Children
Act. Successful completion of the trial, including submission of a
supplemental New Drug Application (sNDA) that includes the full clinical
study report and proposed labeling, fulfills the post-marketing
requirement and results in eligibility for an additional 6 months of
marketing exclusivity for OMIDRIA as well as label expansion to include
information on dosing for pediatric patients. Following FDA’s review of
the sNDA, the FDA-approved indication and labeling for OMIDRIA will be
updated to reflect the trial results. Although conducted in patients
newborn to 3 years old, the FDA agreed that results from this trial can
be extrapolated to patients through 18 years of age, and a label
expansion would be expected to be applicable to that full age range.
“We’re pleased with the positive results of this trial, in which OMIDRIA
was shown to be safe and well tolerated in children and provides
benefits in this younger population consistent with those in adults,”
stated Gregory A. Demopulos, M.D., chairman and chief executive officer
of Omeros. “We look forward to receiving extended patent exclusivity for
OMIDRIA and to expanding its label to include pediatric patients without
age limitation.”
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. Part of 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. OMIDRIA is the first and only FDA-approved drug (1) 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 and (2) that
contains an NSAID for intraocular use. 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 clinical-stage development programs focused on:
complement-associated thrombotic microangiopathies; complement-mediated
glomerulonephropathies; Huntington’s disease and cognitive impairment;
and addictive and compulsive disorders. In addition, Omeros has a
proprietary G protein-coupled receptor (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 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 Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission on November 9, 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161121005365/en/
Source: Omeros Corporation
Cook Williams Communications, Inc.
Jennifer Cook Williams,
360-668-3701
Investor and Media Relations
jennifer@cwcomm.org
