EyePoint Pharmaceuticals Presents Interim Masked Safety Data and Patient Baseline Characteristics for DAVIO 2 Clinical Trial at OIS Retina Innovation Summit
27 Julho 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 interim
masked safety data and baseline patient demographics from its Phase
2 DAVIO 2 clinical trial of EYP-1901, a potential sustained
delivery maintenance treatment for wet age-related macular
degeneration (wet AMD). These data are being presented today at the
OIS Retina Innovation Summit in Seattle, WA by Nancy Lurker,
Executive Vice-Chair of EyePoint Pharmaceuticals.
“EYP-1901 continues to demonstrate an excellent
safety profile in the Phase 2 DAVIO 2 trial with no reported
drug-related ocular serious adverse events (SAEs) and no reported
drug-related systemic SAEs in the 160 enrolled patients as of July
1, 2023,” said Jay S. Duker, M.D., President and Chief Executive
Officer of EyePoint Pharmaceuticals. “Safety is paramount for
both patients and physicians in the development of ophthalmic
treatments, and these data support EYP-1901’s continued track
record of safety in humans. We are developing EYP-1901 as a
sustained delivery therapeutic option to maintain vision in a
majority of wet AMD patients for up to six-months or longer, while
also reducing the treatment burden of frequent injections and
improving treatment compliance. Additionally, we are also pleased
to present the Phase 2 DAVIO 2 patient baseline characteristics,
demonstrating DAVIO 2 patients had better starting visual acuity
and less central subfield thickness (CST) than the Phase 1 DAVIO
cohort. We look forward to sharing our topline results from the
DAVIO 2 trial in December of this year.”
A masked safety summary as of July 1, 2023 found
that there have been no reported drug-related ocular SAEs and no
reported drug-related systemic SAEs in the DAVIO 2 trial. There
were two ocular SAEs unrelated to EYP-1901 in the trial:
- Retinal detachment in a study eye
detected at week 1 (one week post initial aflibercept injection,
prior to EYP-1901 injection)
- Retinal hemorrhage in a non-study
fellow eye
EyePoint also presented the Phase 2 DAVIO 2
trial screening characteristics and provided a comparison to
baseline demographics of the Phase 1 DAVIO patients. Interim
baseline data on patients in the Phase 2 DAVIO 2 trial as of July
1, 2023 reveal that patients feature a mean best corrected visual
acuity (BCVA) of 74 letters, compared with a mean BCVA of 69
letters in the Phase 1 DAVIO trial. Mean CST in the Phase 2 DAVIO 2
trial was 265 μm, compared to 299 μm in the Phase 1 DAVIO trial.
Mean age of patients in the Phase 2 DAVIO 2 trial is 76 years old,
compared to 77.4 years old in the Phase 1 DAVIO trial.
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 bioerodible 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 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 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; 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
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. 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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