EyePoint Pharmaceuticals Announces Assignment of Permanent J-Code for DEXYCU™ by the Center for Medicare and Medicaid Servi...
November 12 2018 - 7:00AM
EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT), a specialty
biopharmaceutical company committed to developing and
commercializing innovative ophthalmic products, today announced
that the Centers for Medicare and Medicaid Services (CMS) has
assigned a specific and permanent reimbursement J-code through the
Healthcare Common Procedure Coding System (HCPCS) for
DEXYCU™ (dexamethasone intraocular suspension) 9%. DEXYCU is
the first and only FDA-approved, single dose, sustained-release,
intracameral steroid for the treatment of postoperative
inflammation.
“The issuance of a specific and permanent J-code
for DEXYCU is another key milestone for the Company that allows for
a convenient and simplified reimbursement process that is familiar
to administering physicians and the greater insurance community,”
said Nancy Lurker, President and Chief Executive Officer of
EyePoint Pharmaceuticals. “The addition of a permanent and specific
J-code is also important to our commercial strategy as such codes
are utilized by CMS and commercial insurers enabling us to address
the entire population of patients requiring postoperative ocular
inflammation treatment in the U.S. We continue to expect to
commercially launch DEXYCU in the U.S. in the first half of
calendar 2019 following the completion of a successful commercial
supply scale-up.”
The code, J1095, will become effective on
January 1, 2019, and will replace the previously issued C-code for
DEXYCU (C9034) that became effective on October 1, 2018. The
Company still retains transitional pass-through status for DEXYCU
from CMS for approximately three years.
About EyePoint
Pharmaceuticals
EyePoint Pharmaceuticals, Inc. (formerly pSivida
Corp.) (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 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 intraocular pressure increased, 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., is currently
sold directly in the U.S. and several EU countries. Retisert®
(fluocinolone acetonide intravitreal implant), for posterior
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, LinkedIn, Facebook
and Google+.
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 plans to commercialize
YUTIQ and DEXYCU, the expected timing of release of the 24-month
and 36-month patient follow-up data for YUTIQ and our expectations
regarding the timing of a filing of an application for approval of
a next-generation, shorter-duration treatment for posterior segment
uveitis, 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 include uncertainties
with respect to: our ability to achieve profitable operations and
access to needed capital; fluctuations in our operating results;
our ability to successfully produce commercial supply of YUTIQ and
DEXYCU and commercialize YUTIQ and DEXYCU in the U.S.; our ability
to successfully build a commercial infrastructure and enter into
and maintain commercial agreements for the launch of DEXYCU and
YUTIQ; the development of our next-generation YUTIQ short-acting
treatment for uveitis; potential off-label sales of ILUVIEN for
non-infectious posterior segment uveitis (“NIPU”); consequences of
fluocinolone acetonide side effects; successful commercialization
of, and receipt of revenues from, ILUVIEN for diabetic macular
edema (“DME”) which depends on the ability of Alimera Sciences,
Inc. (“Alimera”) to continue as a going concern; 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 obtain marketing approval for ILUVIEN in its licensed
territories for NIPU; potential declines in Retisert royalties; our
ability to market and sell products; the success of current and
future license agreements, including our agreement with Alimera;
termination or breach of current license agreements, including our
agreement with Alimera; 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; effects of the potential exit of the United Kingdom
from the European Union; legislative or regulatory changes;
volatility of stock price; possible dilution; absence of dividends;
and other factors described in our filings with the Securities and
Exchange Commission. You should read and interpret any
forward-looking statements in light of these risks. 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(646)
368-8014kimberly@argotpartners.com
Joseph Rayne(617) 340-6075 joseph@argotpartners.com
Media:Thomas Gibson(201)
476-0322tom@tomgibsoncommunications.com
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