EyePoint Pharmaceuticals’ YUTIQ™ for Posterior Segment Uveitis to be Presented at the 2018 Association for Research in Vi...
18 April 2018 - 9:00PM
EyePoint Pharmaceuticals (NASDAQ:EYPT) (ASX:PVA), a
specialty biopharmaceutical company committed to developing
and commercializing innovative ophthalmic products, today
announced that two abstracts supporting the Company's YUTIQ™
(fluocinolone acetonide intravitreal implant) 0.18 mg three-year
micro-insert for noninfectious posterior segment uveitis have been
accepted for presentation at the Association for Research in Vision
and Ophthalmology (ARVO) 2018 Annual Meeting being held in
Honolulu, Hawaii, from April 29 – May 3, 2018.
- The abstract accepted for a paper presentation is titled
“Safety and Efficacy of an intravitreal 0.18 mg
fluocinolone acetonide insert (FAi) for the treatment of
non-infectious posterior segment uveitis (NIPU) – pooled results of
two phase 3 trials”. The data will be presented by Eric
Suhler, M.D., Casey Eye Institute-OHSU and VA Portland HCS,
Portland, Oregon, during the session titled: “Advances in Clinical
Therapeutics for Uveitis” on Thursday, May 3, 2018, from 12:00 p.m.
to 12:15 p.m. HST.
- The abstract accepted for a poster presentation is titled
“Controlling Posterior Segment Uveitic Recurrences: Results
from a Phase 3 Study of 0.18 mg fluocinolone acetonide insert (FAi)
in subjects with chronic non-infectious uveitis affecting the
posterior segment”. The data will be presented
by Quan Nguyen, M.D., Byers Eye Institute, Stanford
University, Palo Alto, California, during the session titled
“Uveitis and Scleritis: Therapeutics” on Sunday, April 29, 2018,
from 1:00 p.m. to 2:45 p.m. HST.
"ARVO is one of the most important ophthalmology
conferences of the year and we are extremely pleased that data from
our YUTIQ Phase 3 studies has been selected for presentations at
ARVO and we look forward to sharing the data with retinal and
uveitis specialists," commented Nancy Lurker, President and Chief
Executive Officer. "Our NDA for YUTIQ for the treatment of
noninfectious posterior segment uveitis is currently under review
by the FDA with a PDUFA date of November 5, 2018. We believe that,
if approved, YUTIQ has the potential to become an important new
treatment option for the thousands of patients suffering from this
disease, which is the third leading cause of blindness.”
About Noninfectious Posterior Segment
UveitisNoninfectious posterior segment uveitis is a
chronic inflammatory disease affecting the posterior segment of the
eye, often involving the retina, which is believed to be a leading
cause of blindness in the developed and developing countries. It
affects people of all ages, producing swelling and destroying eye
tissues, which can lead to severe vision loss and blindness. In the
U.S., posterior segment uveitis affects between 80,000 - 100,000
people. Today, patients with posterior uveitis are typically
treated with systemic steroids, but over time frequently develop
serious side effects that can limit effective dosing. Patients then
often progress to steroid-sparing therapy with systemic immune
suppressants or biologics, which themselves can have severe side
effects including an increased risk of cancer.
About EyePoint
PharmaceuticalsEyePoint Pharmaceuticals
(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. The Company has developed
three of only four FDA-approved sustained-release treatments
for back-of-the-eye diseases. In addition, DEXYCU™
(dexamethasone intraocular suspension) 9% was approved by U.S.
Food and Drug Administration (FDA) on February 9,
2018. DEXYCU is administered as a single intraocular dose at
the end of ocular surgery for postoperative inflammation and it is
the first and only FDA approved intraocular product with
this indication. ILUVIEN® (fluocinolone acetonide
intravitreal implant), a micro-insert for diabetic macular edema,
licensed to Alimera Sciences, 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. The New Drug Application (NDA) for our lead product
candidate, YUTIQ™ micro-insert for the treatment of non-infectious
uveitis affecting the posterior segment of the eye, has been
accepted for filing by the FDA and is currently under
standard review with a Prescription Drug User Fee Act (PDUFA) date
of November 5, 2018. The Company's pre-clinical development
program is focused on using its core Durasert platform technology
to deliver drugs to treat wet age-related macular degeneration,
glaucoma, osteoarthritis 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 REFORM 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 or believe may occur in the future 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; successful
commercialization of, and receipt of revenues from, ILUVIEN® for
diabetic macular edema ("DME"), which depends on Alimera's ability
to continue as a going concern; Alimera's ability to obtain
marketing approvals and the effect of pricing and reimbursement
decisions on sales of ILUVIEN; the number of clinical trials and
data required for the Durasert technology for the treatment of
non-infectious uveitis affecting the posterior segment of the eye,
uveitis marketing application approval in the U.S.; our ability to
use data in promotion for YUTIQ micro-insert for the treatment of
noninfectious uveitis affecting the posterior segment of the eye,
U.S. NDA approval which includes clinical trials outside the U.S.;
our ability to successfully commercialize DEXYCU in the U.S.; our
ability to obtain stockholder approval for portions of the EW and
SWK investments; our ability to successfully commercialize YUTIQ
three-year uveitis, if approved, in the U.S.; potential off-label
sales of ILUVIEN for uveitis; consequences of fluocinolone
acetonide side effects; the development of our next-generation
Durasert shorter-duration treatment for posterior segment uveitis;
potential declines in Retisert® royalties; efficacy and the future
development of an implant to treat severe osteoarthritis; our
ability to successfully develop product candidates, initiate and
complete clinical trials and receive regulatory approvals; 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, 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 U.K.
exit from the EU; 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.
Contact
Barbara Ryan - Investorsbarbara@barbararyanadvisors.co
203-274-2825
Thomas Gibson -
Mediatom@tomgibsoncommunications.com201-476-0322
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