-Topline data expected in the second half of 2023-
WATERTOWN, Mass., Aug. 1, 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 that the first patient has been dosed in
the Phase 2 "Durasert® and Vorolanib in Ophthalmology 2"
(DAVIO 2) clinical trial of EYP-1901, an investigational sustained
delivery anti-vascular endothelial growth factor (anti-VEGF)
treatment for wet age-related macular degeneration (wet AMD).
"We are very pleased to announce the initiation of the Phase 2
DAVIO 2 clinical trial of EYP-1901 for wet AMD. Using a 'Treat to
Maintain' therapeutic approach, EYP-1901 has the potential to
transform the wet AMD treatment landscape by sustaining a majority
of patients up to six months without supplemental anti-VEGF
treatment, thereby greatly reducing the treatment burden,"
said Nancy Lurker, Chief Executive Officer of EyePoint
Pharmaceuticals. "We are encouraged by the safety and efficacy
results from our Phase 1 DAVIO trial, including no reports of
ocular or drug related systemic serious adverse events and strong
durability data with 53% of patients requiring no supplemental
treatment up to six months. We anticipate initial topline data from
our Phase 2 trial in the second half of 2023."
The twelve-month, randomized, controlled Phase 2 DAVIO 2 trial
of EYP-1901 for wet AMD is expected to enroll approximately 150
patients, previously treated with a standard-of-care anti-VEGF
therapy, 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 best
corrected visual acuity (BCVA) compared to the aflibercept control
six-months after the EYP-1901 injection. Secondary efficacy
endpoints include change in central subfield thickness (CST) as
measured by optical coherence tomography (OCT), time to first
supplemental anti-VEGF, 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 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 DAVIO Phase 1 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% and 35% of eyes did not
require supplemental anti-VEGF injections up to six and twelve
months, respectively, following a single dose of EYP-1901. Phase 2
clinical trials are underway for wet AMD and planned in
non-proliferative diabetic retinopathy in Q3 2022 and diabetic
macular edema in 2023. 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 anti-VEGF
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 novel sustained delivery 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.