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 new research related to the clinical utility of OMIDRIA (phenylephrine and ketorolac injection) 1% / 0.3% and the importance of preempting intraoperative miosis and inflammation during cataract surgery will be presented at the upcoming Association for Research in Vision and Ophthalmology (ARVO) 2016 Annual Meeting in Seattle, Washington, May 1 - 5, 2016, and the American Society of Cataract and Refractive Surgery (ASCRS) Congress in New Orleans, Louisiana, May 6 - 10, 2016. Presentations will address the beneficial effects demonstrated in case-controlled studies of OMIDRIA on complication rates, on use of pupil-expanding devices, on surgical times and on postoperative visual acuity.
“As utilization of OMIDRIA in cataract surgery continues to grow, we are accumulating a wealth of data across varied ophthalmic conditions, clinical settings and practice patterns,” said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “These findings underscore the important benefits of OMIDRIA to both patients and surgeons – improving outcomes, streamlining procedures and reducing risks.”
The following poster will be presented at ARVO:
Sunday, May 1: 3:15 PM – 5:00 PM
Washington State Convention Center
– Poster Session D0313; Abstract #1299
A comparison of the
frequency of use of the Malyugin ring with & without intracameral
phenylephrine & ketorolac 1% / 0.3%(phenyl/keto) injection at the time
of routine cataract surgery. Bucci FA, Fluet A.
The following oral presentations will be given at ASCRS:
Sunday, May 8: 9:14 AM – 9:19 AM
New Orleans Ernest N. Morial
Convention Center – Room 223
Rates of complications
associated with intraoperative miosis during cataract surgery in the U.S.
Silverstein S, Katsev D, Connolly M, Sierra M, Schaaf D, Melfi C.
Sunday, May 8: 3:47 PM – 3:52 PM
New Orleans Ernest N. Morial
Convention Center – Room 223
Use of iris fixation ring with
and without intracameral phenylephrine/ketorolac in patients with poor
pupil dilation. Visco D.
Monday, May 9: 8:02 AM – 8:07 AM
New Orleans Ernest N. Morial
Convention Center – Room 224
Initial experience, visual
outcomes, and efficacy of intracameral phenylephrine and ketorolac (1.0%
/ 0.3%) during cataract surgery. Rosenberg E, Nattis A, Alevi D,
Donnenfeld E.
Monday, May 9: 8:07 AM – 8:12 AM
New Orleans Ernest N. Morial
Convention Center – Room 224
Effect of
phenylephrine-ketorolac in maintaining mydriasis and intraoperative and
first 24-hour comfort level during routine cataract surgery. Fry
L, Robinson A.
Monday, May 9: 8:22 AM – 8:27 AM
New Orleans Ernest N. Morial
Convention Center – Room 224
Intracameral
phenylephrine/ketorolac to maintain pupil diameter and reduce
postoperative pain regardless of cataract surgery duration.
Walters T, Schaaf D, Buznego C.
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 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
Annual Report on Form 10-K filed with the Securities and Exchange
Commission on March 15, 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.