EyePoint Pharmaceuticals Announces Permanent and Specific J-Code for YUTIQ® Now in Effect
October 02 2019 - 4:05PM
EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT), a specialty
biopharmaceutical company committed to developing and
commercializing innovative ophthalmic products, announced today
that the Company’s permanent and specific J-Code for YUTIQ®
(fluocinolone acetonide intravitreal implant) 0.18 mg three-year
micro-insert for chronic, non-infectious uveitis affecting the
posterior segment of the eye is now in effect. The code, J7314, was
issued by the Centers for Medicare and Medicaid Services (CMS) one
quarter earlier than under prior CMS policy.
“Uveitis specialists, insurers and patients now
stand to benefit from a more streamlined, efficient and permanent
reimbursement process with the addition of our new YUTIQ-specific
J-Code,” said Nancy Lurker, President and Chief Executive Officer
of EyePoint Pharmaceuticals. “This milestone is particularly
important as J-Codes are utilized by CMS and commercial insurers,
and the early issuance allows for our best-in-class approval and
reimbursement process to be in effect sooner than we had previously
anticipated. Since our YUTIQ commercial launch in February, we
continue to receive strong reception from treating physicians and
the greater medical community on YUTIQ’s clinical and long-duration
treatment profile.”
About EyePoint
Pharmaceuticals
EyePoint Pharmaceuticals, Inc.
(www.eyepointpharma.com), headquartered in Watertown, MA, is a
specialty biopharmaceutical company committed to developing and
commercializing innovative ophthalmic products in indications with
high unmet medical need to help improve the lives of patients with
serious eye disorders. With the approval by the FDA on October 12,
2018 of the YUTIQ® three-year treatment of chronic non-infectious
uveitis affecting the posterior segment of the eye, the Company has
developed five of the six FDA-approved sustained-release treatments
for eye diseases. The most common adverse reactions reported for
YUTIQ were cataract development and increases in intraocular
pressure. DEXYCU® was approved by the FDA on February 9, 2018.
DEXYCU, administered as a single intraocular dose at the end of
ocular surgery for the treatment of postoperative inflammation, is
the first and only FDA-approved intraocular product with this
indication. The most common adverse reactions reported by 5-15% of
patients were increased intraocular pressure, corneal edema and
iritis. DEXYCU employs the Verisome® extended-release drug delivery
technology, which encompasses a broad number of related, but
distinct drug delivery systems with the potential of incorporating
an extensive range of active agents, including small molecules,
proteins and monoclonal antibodies. ILUVIEN® (fluocinolone
acetonide intravitreal implant), a micro-insert for diabetic
macular edema, licensed to Alimera Sciences, Inc. (“Alimera”), is
currently sold directly in the U.S. and several EU countries.
Retisert® (fluocinolone acetonide intravitreal implant), for
non-infectious posterior segment uveitis, is licensed to and sold
by Bausch & Lomb, Inc. The Company's pre-clinical development
program is focused on using its core Durasert™ and the Verisome
platform technologies to deliver drugs to treat wet age-related
macular degeneration, glaucoma, and other diseases. To learn more
about the Company, please visit www.eyepointpharma.com and connect
on Twitter and LinkedIn.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE
SECURITIES LITIGATION ACT OF 1995: Various statements made in this
release are forward-looking, and are inherently subject to risks,
uncertainties and potentially inaccurate assumptions. All
statements that address activities, events or developments that we
intend, expect, plan or believe may occur in the future, including
but not limited to statements about our commercialization of YUTIQ
and DEXYCU, the potential for our products to alter the treatment
landscape for ocular diseases; our expectations regarding the
timing of our planned sNDA filing for our YUTIQ line extension
shorter-acting treatment for non-infectious uveitis affecting the
posterior segment of the eye; the expected use of proceeds from our
debt refinancing and equity offering and our expectation that the
Company’s existing cash and cash equivalents at June 30, 2019 and
cash inflows from anticipated YUTIQ and DEXYCU product sales will
be sufficient to fund our operating plan into 2020, are
forward-looking statements. Some of the factors that could cause
actual results to differ materially from the anticipated results or
other expectations expressed, anticipated or implied in our
forward-looking statements are risks and uncertainties inherent in
our business including, without limitation: our ability to achieve
profitable operations and access to needed capital; fluctuations in
our operating results; our ability to successfully produce
sufficient commercial quantities of YUTIQ and DEXYCU and to
successfully commercialize YUTIQ and DEXYCU in the U.S.; our
ability to sustain and enhance an effective commercial
infrastructure and enter into and maintain commercial agreements
for YUTIQ and DEXYCU; the regulatory approval and successful
release of our YUTIQ line extension shorter-duration treatment for
non-infectious uveitis affecting the posterior segment of the eye;
potential off-label sales of ILUVIEN for non-infectious uveitis
affecting the posterior segment of the eye; consequences of
fluocinolone acetonide side effects for YUTIQ; consequences of
dexamethasone side effects for DEXYCU; successful commercialization
of, and receipt of revenues from, ILUVIEN for diabetic macular
edema, or DME; Alimera’s ability to obtain additional marketing
approvals and the effect of pricing and reimbursement decisions on
sales of ILUVIEN for DME; Alimera’s ability to commercialize
ILUVIEN for non-infectious uveitis affecting the posterior segment
of the eye in the territories in which Alimera is licensed to do
so; declines in Retisert royalties; our ability to market and sell
products; the success of current and future license agreements;
termination or breach of current license agreements; our dependence
on contract research organizations, contract sales organizations,
vendors and investigators; effects of competition and other
developments affecting sales of products; market acceptance of
products; effects of guidelines, recommendations and studies;
protection of intellectual property and avoiding intellectual
property infringement; retention of key personnel; product
liability; industry consolidation; compliance with environmental
laws; manufacturing risks; risks and costs of international
business operations; volatility of stock price; possible dilution;
absence of dividends; and other factors described in our filings
with the Securities and Exchange Commission. We cannot guarantee
that the results and other expectations expressed, anticipated or
implied in any forward-looking statement will be realized. A
variety of factors, including these risks, could cause our actual
results and other expectations to differ materially from the
anticipated results or other expectations expressed, anticipated or
implied in our forward-looking statements. Should known or unknown
risks materialize, or should underlying assumptions prove
inaccurate, actual results could differ materially from past
results and those anticipated, estimated or projected in the
forward-looking statements. You should bear this in mind as you
consider any forward-looking statements. Our forward-looking
statements speak only as of the dates on which they are made. We do
not undertake any obligation to publicly update or revise our
forward-looking statements even if experience or future changes
makes it clear that any projected results expressed or implied in
such statements will not be realized.
Contacts
Investors:
Argot PartnersKimberly Minarovich or Joe
Rayne212-600-1902eyepoint@argotpartners.com
Media:
Thomas Gibson(201) 476-0322tom@tomgibsoncommunications.com
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