CMS Confirms Continued Separate Payment for Omeros’ FDA-Approved OMIDRIA® in Ambulatory Surgery Centers
December 03 2020 - 6:30AM
Business Wire
— Separate payment for OMIDRIA retroactively
effective as of October 1, 2020 —
Omeros Corporation (Nasdaq: OMER) announced today that the
Centers for Medicare & Medicaid Services (CMS) confirmed
separate payment in ambulatory surgery centers (ASCs) for Omeros’
cataract surgery drug OMIDRIA® (phenylephrine and ketorolac
intraocular solution) 1%/0.3%. In its final rule directed to the
Medicare outpatient prospective payment system (OPPS) and the ASC
payment system for calendar year 2021, CMS confirmed that OMIDRIA
qualifies for separate payment under CMS’ policy for non-opioid
pain management surgical drugs when used in the ASC setting. This
separate payment for OMIDRIA is effective retroactively beginning
October 1, 2020.
“Omeros appreciates CMS’ decision to continue paying separately
for our ophthalmic drug OMIDRIA,” said Gregory A. Demopulos, M.D.,
Omeros’ chairman and chief executive officer. “Having just come off
its pass-through status, this is the first time that OMIDRIA
qualifies under CMS’ payment policy for non-opioid pain-management
surgical drugs in the ASC setting. In addition to reducing patient
exposure to opioids, CMS’ decision continues to provide important
access to OMIDRIA for Medicare beneficiaries and to allow
ophthalmic surgeons to use their best medical judgment to treat
those patients. This is a good outcome for surgical facilities,
surgeons and their patients.”
OMIDRIA is the first and only FDA-approved product for use
during cataract or lens replacement surgery that prevents pupil
constriction during surgery and reduces postoperative ocular pain.
In post-marketing studies, OMIDRIA has been shown to have a broad
range of benefits, including the reduction of sight-threatening
complications and mitigating the need for intra- and postoperative
steroids. OMIDRIA is approved for use in both adults and
children.
About OMIDRIA®
Omeros’ OMIDRIA® (phenylephrine and ketorolac intraocular
solution) 1% / 0.3% is the first and only FDA-approved product of
its kind and is marketed in the U.S. 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 to (1)
prevent intraoperative floppy iris syndrome (IFIS) and iris
prolapse, (2) significantly reduce complication rates (including
sight-threatening cystoid macular edema and breakthrough iritis),
use of pupil-expansion devices, and surgical times, (3)
significantly reduce intraoperative use of the opioid fentanyl and
postoperative prescription opioids, (4) enable performance of
surgery and postoperative care without the use of steroids, and (5)
significantly improve uncorrected visual acuity on the first day
following cataract surgery. While OMIDRIA is broadly indicated for
use in cataract surgery, the post-launch outcomes cited above are
not in its currently approved labeling.
Important Safety 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 percent or greater 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.
About Omeros Corporation
Omeros is a commercial-stage biopharmaceutical company committed
to discovering, developing and commercializing small-molecule and
protein therapeutics for large-market and orphan indications
targeting inflammation, complement-mediated diseases, disorders of
the central nervous system and immune-related diseases, including
cancers. Its commercial product OMIDRIA (phenylephrine and
ketorolac intraocular solution) 1%/0.3% continues to gain market
share in cataract surgery. Omeros’ lead MASP-2 inhibitor
narsoplimab targets the lectin pathway of complement and is the
subject of a rolling biologics license application under review by
FDA for the treatment of hematopoietic stem cell
transplant-associated thrombotic microangiopathy. Narsoplimab is
also in multiple late-stage clinical development programs focused
on other complement-mediated disorders, including IgA nephropathy,
atypical hemolytic uremic syndrome and COVID-19. Omeros’ MASP-3
inhibitor OMS906, which targets the complement system’s alternative
pathway, recently entered the clinic, and the company’s PDE7
inhibitor OMS527 has successfully completed its Phase 1 trial.
Omeros’ pipeline holds a diverse group of preclinical programs
including a novel antibody-generating technology and a proprietary
GPCR platform through which it controls 54 new GPCR drug targets
and their corresponding compounds. One of these novel targets,
GPR174, modulates a new cancer immunity axis recently discovered by
Omeros, and the company is advancing small-molecule GPR174
inhibitors.
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,” “can,” “could,” “estimate,”
“expect,” “goal,” “intend,” “likely”, “look forward to,” “may,” “on
track,” “plan,” “potential,” “predict,” “project,” “prospects,”
“scheduled,” “should,” “slated,” “targeting,” “will,” “would” and
similar expressions and variations thereof. Forward-looking
statements, including statements regarding anticipated regulatory
submissions, the timing and results of ongoing or anticipated
clinical trials, and the therapeutic application of Omeros’
investigational product, 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, the impact of COVID-19 on our business, financial
condition and results of operations, regulatory oversight, changes
in reimbursement and payment policies by government and commercial
payers or the application of such policies, intellectual property
claims, competitive developments, litigation, 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 (SEC) on March 2, 2020, as
supplemented by our Quarterly Reports on Form 10-Q filed with the
SEC and subsequent filings with the SEC. 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,
whether as a result of new information, future events or otherwise,
except as required by applicable law.
Source: Omeros Corporation
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Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations 360.668.3701 jennifer@cwcomm.org
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