EyePoint Pharmaceuticals Announces First Patient Dosed in Phase 2 PAVIA Clinical Trial of EYP-1901 for the Treatment of Non-Proliferative Diabetic Retinopathy
September 29 2022 - 7:00AM
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
PAVIA clinical trial of EYP-1901, a potential sustained delivery
intravitreal anti-vascular endothelial growth factor (anti-VEGF)
treatment targeting non-proliferative diabetic retinopathy (NPDR).
“We are excited to announce the first patient
dosing of the Phase 2 PAVIA clinical trial of EYP-1901 for NPDR, a
serious eye disorder affecting almost one-third of adults over the
age of 40 with diabetes that can lead to severe vision loss if left
uncontrolled,” said Jay Duker, M.D., Chief Operating Officer
of EyePoint Pharmaceuticals. “Despite the severe nature of
this disease, the current standard-of-care is no treatment until a
patient develops sight-threatening complications. There remains a
lack of approved treatments for this serious eye disease, leaving a
significant opportunity for a long-acting treatment option that
maintains the patient’s existing vision proactively. Building on
EYP-1901’s excellent safety and efficacy results from our Phase 1
DAVIO trial in wet AMD, we believe that EYP-1901 has the potential
to improve the current treatment paradigm as a sustained delivery
maintenance treatment for NPDR and significantly improve the lives
of patients living with this serious eye disorder.”
The 12-month, randomized, controlled Phase 2 PAVIA
clinical trial of EYP-1901 for NPDR is expected to enroll
approximately 105 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. The primary
efficacy endpoint of the trial is improvement of at least two
diabetic retinopathy severity scale (DRSS) severity levels as of
week 36 after the EYP-1901 injection. Secondary endpoints include
vision-threatening complications, occurrence of DME and/or
proliferative disease, retinal ischemia/nonperfusion and safety.
More information about the study is available at clinicaltrials.gov
(identifier: NCT05383209).
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 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 any supplemental anti-VEGF injections up to six and
twelve months, respectively, following a single dose of EYP-1901.
Phase 2 studies are underway for wet AMD and non-proliferative
diabetic retinopathy and are planned for diabetic macular edema in
2023. Vorolanib is licensed to EyePoint exclusively by Equinox
Sciences for the localized treatment of all ophthalmic
diseases.
About Non-Proliferative Diabetic
Retinopathy Diabetic retinopathy affects about 40 percent
of people with diabetes and is projected to impact 14.6 million
Americans by 2050. Non-proliferative diabetic retinopathy (NPDR) is
the early stage of the disease in which symptoms may be mild or
nonexistent. In NPDR, the blood vessels in the retina are weakened,
and tiny bulges in the blood vessels, called microaneurysms, may
leak fluid into the retina. This leakage may lead to swelling of
the macula and cause mild vision changes and blurriness. NPDR can
lead to more serious complications or severe vision loss if left
uncontrolled. The current standard of care for patients
experiencing vision loss include intravitreal injections of
anti-VEGF agents or laser photocoagulation, which can become a
burden on patients, caregivers and physicians due to the longevity
of the disease and need for consistent therapies.
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 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, including YUTIQ® for the treatment of posterior
segment uveitis, which is currently marketed by the Company.
EyePoint Pharmaceuticals is headquartered in Watertown,
Massachusetts.
Forward Looking
StatementsEYEPOINT 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
TartagliaStern IRDirect:
212-698-8700christina.tartaglia@sternir.com
Media ContactAmy PhillipsGreen
Room CommunicationsDirect:
412-327-9499aphillips@greenroompr.com
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