Data reinforces strong safety and efficacy for
EYP-1901 as a potential six-month maintenance treatment for
previously treated wet AMD
No dose limiting toxicities, no ocular serious
adverse events (SAEs) and no drug-related systemic SAEs
observed
Stable visual acuity and optical coherence
tomography observed from a single treatment
Phase 2 clinical trial (DAVIO2) in wet AMD
patient dosing anticipated in Q3 2022
WATERTOWN, Mass., July 15,
2022 /PRNewswire/ -- EyePoint Pharmaceuticals, Inc.
(NASDAQ: EYPT), a pharmaceutical company committed to developing
and commercializing therapeutics to improve the lives of patients
with serious eye disorders, today announced 12-month data from the
Phase 1 "Durasert® and Vorolanib in Ophthalmology"
(DAVIO) clinical trial evaluating EYP-1901, a sustained delivery
anti-vascular endothelial growth factor (anti-VEGF) therapy
targeting wet age-related macular degeneration (wet AMD) as a
potential every six-month treatment. These data are being presented
today at the American Society of Retina Specialists (ASRS) 2022
Annual Meeting by Rishi Singh, M.D.,
Staff Physician, Cleveland Clinic Florida, President – Cleveland
Clinic Martin Hospitals.
"The final 12-month results from the DAVIO clinical trial
highlight EYP-1901's continued positive safety and efficacy profile
with promising durability as a potential every six-month
maintenance therapy for previously treated wet AMD," said
Rishi Singh, M.D., a member of
EyePoint's Scientific Advisory Board. "We are grateful to the
patients, investigators and site staff who participated in the
Phase 1 DAVIO trial."
"We are extremely pleased with the excellent safety and efficacy
results from our Phase 1 DAVIO trial. There remains a significant
opportunity for a safe and effective sustained delivery maintenance
treatment in wet AMD, and the DAVIO trial demonstrates that
EYP-1901 has the potential to maintain a majority of patients for
up to six months with no supplemental anti-VEGF therapy,"
said Nancy Lurker, Chief Executive Officer of EyePoint
Pharmaceuticals. "We look forward to beginning to dose patients in
the Phase 2 DAVIO2 clinical trial for EYP-1901 in wet AMD and
anticipate top line data in the second half of 2023."
The final twelve-month data presented from the Phase 1 DAVIO
clinical trial showed no reports of ocular SAEs or drug-related
systemic SAEs. There were no reported events of vitreous floaters,
endophthalmitis, retinal detachment, implant migration in the
anterior chamber, retinal vasculitis, posterior segment
inflammation, or retinal vascular occlusive events. Additionally,
updated data from the twelve-month follow-up confirm stable best
corrected visual acuity (BCVA) (-4.12 ETDRS letters), stable
central subfield thickness (CST) on optical coherence tomography
(OCT) (-2.76 μm), and an expected late increase in supplemental
anti-VEGF therapy given the insert's expected drug depletion, with
35% of eyes supplement free up to twelve months versus 53%
supplement free up to six months. Additionally, there continued to
be positive treatment burden reduction of 74% at twelve months
versus 79% at six-months.
EyePoint anticipates that the first patient in the twelve-month,
randomized, controlled Phase 2 clinical trial (DAVIO2) of EYP-1901
for wet AMD will be dosed in Q3 2022. The trial is expected to
enroll approximately 150 wet AMD
patients previously treated with a standard-of-care anti-VEGF
therapy and randomly assigned to one of two doses of EYP-1901
(approximately 2 mg or 3 mg) versus an on-label 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 DAVIO2
trial is non-inferiority to the aflibercept control, as measured by
change in BCVA six-months after the EYP-1901 injection. Secondary
efficacy endpoints include change in CST as measured by OCT, time
to first supplemental anti-VEGF, and safety. More information about
the study is available at clinicaltrials.gov (identifier:
NCT05381948).
About EYP-1901
EYP-1901 is being developed as an investigational sustained
delivery treatment, initially in wet age-related macular
degeneration (wet AMD) combining a bioerodible formulation of
EyePoint's proprietary Durasert® delivery technology
with vorolanib, a tyrosine kinase inhibitor. Positive twelve-month
safety and efficacy data from the Phase 1 DAVIO clinical trial of
EYP-1901 showed no reports of ocular or drug-related systemic
serious adverse events and no dose limiting toxicities with
stable visual acuity and OCT. Further, 53% of eyes did not require
supplemental anti-VEGF injections up to six months following a
single dose of EYP-1901. A Phase 2 trial for wet AMD (DAVIO2) is
expected in Q3 2022 and Phase 2 studies are planned for
non-proliferative diabetic retinopathy and diabetic macular edema
in 2H 2022 and 2023, respectively. Vorolanib is licensed to
EyePoint exclusively by Equinox Sciences for the localized
treatment of all ophthalmic diseases.
About Wet AMD
Age-related macular degeneration (AMD) impacts as many as 11
million Americans. About 15% of those affected have neovascular or
wet AMD - the hallmark of which is fluid and bleeding in the center
of the retina, which may lead to irreversible vision loss. The
majority of patients with wet AMD require intravitreal injections
every month or two to control the disease. This intense treatment
regimen represents an ongoing challenge for patients, caregivers,
and physicians.
About EyePoint
Pharmaceuticals
EyePoint Pharmaceuticals (Nasdaq: EYPT) is a pharmaceutical
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 Durasert®
technology for sustained intraocular drug delivery including
EYP-1901, an investigational sustained delivery intravitreal
anti-VEGF treatment initially targeting wet age-related macular
degeneration. The proven Durasert drug delivery platform has been
safely administered to thousands of patients' eyes across four U.S.
FDA approved products, including YUTIQ® for the
treatment of chronic non-infectious uveitis affecting the posterior
segment of the eye, which is currently marketed by the Company.
EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts.
Forward Looking
Statements
EYEPOINT PHARMACEUTICALS 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 use of
proceeds for the offering and other statements identified by words
such as "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 sustained
delivery intravitreal anti-VEGF treatment for serious eye diseases,
including wet age-related macular degeneration; 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; our dependence on contract research
organizations, co-promotion partners, and other outside vendors and
service providers; effects of competition and other developments
affecting sales of our commercialized products, YUTIQ® and DEXYCU®;
market acceptance of our products; product liability; industry
consolidation; compliance with environmental laws; risks and costs
of international business operations; volatility of stock price;
possible dilution; absence of dividends; the continued impact of
the COVID-19 pandemic on EyePoint's business, the medical community
and the global economy; and the impact of general business and
economic conditions. More detailed information on these and
additional factors that could affect EyePoint's actual results are
described in EyePoint's filings with the SEC, including its
Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as revised or supplemented by
its Quarterly Reports on Form 10-Q and other documents filed with
the SEC. All forward-looking statements in this news release speak
only as of the date of this news release. 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 Tartaglia
Stern IR
Direct: 212-698-8700
christina.tartaglia@sternir.com
Media Contact
Amy Phillips
Green Room Communications
Direct: 412-327-9499
aphillips@greenroompr.com
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SOURCE EyePoint Pharmaceuticals, Inc.