EyePoint Pharmaceuticals Reports Positive Masked Safety Update for Lead Product Candidate EYP-1901 in Ongoing PAVIA and DAVIO 2 Phase 2 Clinical Trials as of September 1, 2023
11 Setembro 2023 - 8:00AM
EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed
to developing and commercializing therapeutics to improve the lives
of patients with serious eye disorders, today announced positive
interim masked safety data for its lead product candidate EYP-1901
from the Company’s ongoing Phase 2 PAVIA trial evaluating EYP-1901
as a potential nine-month treatment for moderately-severe to severe
non-proliferative diabetic retinopathy (NPDR) and DAVIO 2 trial as
a potential six-month sustained delivery maintenance treatment for
wet age-related macular degeneration (wet AMD). All treatment arms
in the PAVIA trial have reached at least 3-months post-dosing
follow-up as of September 1, 2023.
Approximately 170 patients have received
EYP-1901 with a minimum of three months of follow-up post injection
from the ongoing Phase 2 PAVIA and DAVIO 2 clinical trials and the
completed DAVIO 1 trial with no reported drug-related ocular severe
adverse events (SAEs) and no reported drug-related systemic
SAEs.
“We remain very encouraged by the positive
masked safety results that EYP-1901 has produced to-date in the 17
patients dosed in the Phase 1 DAVIO trial in wet AMD as well as
approximately 150 additional patients in our two Phase 2 clinical
trials: DAVIO 2 and PAVIA. These results bolster our confidence in
EYP-1901 as a potentially paradigm-shifting treatment for patients
who would benefit from a safe, sustained therapeutic option for
VEGF-mediated diseases,” said Jay S. Duker, M.D., President and
Chief Executive Officer of EyePoint Pharmaceuticals. “In the
77 patients enrolled in the Phase 2 PAVIA trial, the investigators
report no drug-related ocular SAEs and no drug-related systemic
SAEs, demonstrating EYP-1901’s excellent safety profile in NPDR for
the first time. We remain excited about the potential for EYP-1901
in NPDR, a chronic disease where over 90% of patients currently
receive no course of treatment apart from observation by their eye
care specialist until they develop sight-threatening complications.
We remain on-track to share our topline results from the DAVIO 2
trial in December of this year and from the PAVIA trial in the
second quarter of 2024.”
In the PAVIA clinical trial, there have been no
reported drug-related ocular SAEs and no reported drug-related
systemic SAEs. There were two ocular SAEs deemed unrelated to
EYP-1901 by investigators:
- Hemorrhagic posterior vitreous
detachment (PVD) in a study eye eight weeks after dosing
- Macular edema leading to vision
loss in the non-study fellow eye
PAVIA is a 12-month, randomized, controlled
Phase 2 clinical trial of EYP-1901 in patients with
moderately-severe to severe NPDR. The trial enrolled 77 patients
randomly assigned to one of two doses of EYP-1901 (approximately 2
mg or 3 mg), or to the control group receiving a sham injection.
EYP-1901 is delivered with a single intravitreal injection in the
physician's office, similar to current FDA approved anti-VEGF
treatments. The primary efficacy endpoint of the trial is
improvement of at least two diabetic retinopathy severity scale
(DRSS) levels as of week 36 after the EYP-1901 injection. Secondary
endpoints include reduction in vision-threatening complications,
occurrence of diabetic macular edema and/or proliferative disease,
retinal ischemia/nonperfusion and safety. More information about
the study is available at clinicaltrials.gov (identifier:
NCT05383209).
DAVIO 2 is a randomized, controlled Phase 2
clinical trial of EYP-1901 in patients with previously treated wet
AMD. All enrolled patients had been previously treated with
standard-of-care anti-VEGF therapy and were randomly assigned to
one of two doses of EYP-1901 (approximately 2 mg or 3 mg) or an
aflibercept control. EYP-1901 is delivered with a single
intravitreal injection in the physician's office, similar to
current FDA approved anti-VEGF treatments. The primary efficacy
endpoint of the DAVIO 2 trial is change in BCVA compared to the
aflibercept control, six-months after the EYP-1901 injection.
Secondary efficacy endpoints include change in CST as measured by
optical coherence tomography (OCT), number of eyes that remain free
of supplemental anti-VEGF injections, number of aflibercept
injections in each group, and safety. More information about the
trial is available at clinicaltrials.gov (identifier:
NCT05381948).
About EYP-1901
EYP-1901 is being developed as an
investigational sustained delivery treatment for retinal disease
combining a bioerodible formulation of EyePoint's proprietary
Durasert® delivery technology (Durasert E™) with vorolanib, a
tyrosine kinase inhibitor. Positive safety and efficacy data from
the Phase 1 DAVIO clinical trial of EYP-1901 in wet AMD showed a
positive safety profile with stable visual acuity and OCT. Further,
the data demonstrated an impressive treatment burden reduction of
75% at six months and 73% at the 12-month visit following a single
dose of EYP-1901. Phase 2 trials are fully enrolled in wet AMD and
non-proliferative diabetic retinopathy, and a diabetic macular
edema trial is planned for initiation in Q1 2024. Vorolanib is
licensed to EyePoint exclusively by Equinox Sciences for the
localized treatment of all ophthalmic diseases.
About EyePoint
Pharmaceuticals
EyePoint Pharmaceuticals (Nasdaq: EYPT) is a
company committed to developing and commercializing therapeutics to
help improve the lives of patients with serious eye disorders. The
Company's pipeline leverages its proprietary erodible Durasert E™
technology for sustained intraocular drug delivery including
EYP-1901, an investigational sustained delivery intravitreal
anti-VEGF treatment currently in Phase 2 clinical trials. The
proven Durasert® drug delivery platform has been safely
administered to thousands of patients' eyes across four U.S. FDA
approved products. EyePoint Pharmaceuticals is headquartered in
Watertown, Massachusetts. For more information visit
www.eyepointpharma.com.
EYEPOINT SAFE HARBOR STATEMENTS UNDER THE
PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any
statements made in this press release deal with information that is
not historical, these are forward-looking statements under the
Private Securities Litigation Reform Act of 1995. Such statements
include, but are not limited to, statements regarding the
sufficiency of our existing cash resources into 2025; our plans and
any other statements about future expectations, prospects,
estimates and other matters that are dependent upon future events
or developments, including statements containing the words “will,”
“potential,” “could,” “can,” “believe,” “intends,” “continue,”
“plans,” “expects,” “anticipates,” “estimates,” “may,” other words
of similar meaning or the use of future dates. Forward-looking
statements by their nature address matters that are, to different
degrees, uncertain. Uncertainties and risks may cause EyePoint’s
actual results to be materially different than those expressed in
or implied by EyePoint’s forward-looking statements. For EyePoint,
this includes uncertainties regarding the timing and clinical
development of our product candidates, including EYP-1901; the
potential for EYP-1901 as a novel sustained delivery treatment for
serious eye diseases, including wet age-related macular
degeneration, non-proliferative diabetic retinopathy and diabetic
macular edema; the effectiveness and timeliness of clinical trials,
and the usefulness of the data; the timeliness of regulatory
approvals; our ability to realize the anticipated benefits of the
2023 sale of YUTIQ® to Alimera Sciences including our potential to
receive additional payments from Alimera pursuant to the our
agreements with Alimera; our ability to manufacture YUTIQ in
sufficient quantities pursuant to our commercial supply agreements
with Alimera and Ocumension Therapeutics; the success of current
and future license agreements, including our agreements with
Alimera, Ocumension, Equinox Science and Betta Pharmaceuticals;
termination or breach of current and future license agreements; our
dependence on contract research organizations, co-promotion
partners, and other outside vendors and service providers; effects
of competition; market acceptance of our products, including our
out-licensed products; product liability; industry consolidation;
compliance with environmental laws; risks and costs of
international business operations; volatility of stock price;
possible dilution; the impact of instability in general business
and economic conditions, including changes in inflation, interest
rates and the labor market; the extent to which COVID-19 impacts
our business and the medical community; protection of our
intellectual property and avoiding intellectual property
infringement; retention of key personnel; manufacturing risks; the
sufficiency of the Company’s cash resources and need for additional
financing; 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
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forward-looking statements. Our forward-looking statements speak
only as of the dates on which they are made. EyePoint undertakes no
obligation to update or revise any forward-looking statement,
whether as a result of new information, future events or
otherwise.
Investors:Christina
TartagliaStern IRDirect:
212-698-8700christina.tartaglia@sternir.com
Media Contact:Amy PhillipsGreen
Room CommunicationsDirect:
412-327-9499aphillips@greenroompr.com
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