EyePoint Pharmaceuticals Announces First Patient Dosed in Phase 2 VERONA Clinical Trial of EYP-1901 for the Treatment of Diabetic Macular Edema
10 Janeiro 2024 - 9:00AM
EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed
to developing and commercializing therapeutics to improve the lives
of patients with serious retinal diseases, today announced that the
first patient has been dosed in the Phase 2 VERONA clinical trial
of EYP-1901 for diabetic macular edema (DME). EYP-1901 is an
investigational sustained delivery therapy containing vorolanib, a
selective tyrosine kinase inhibitor formulated in bioerodible
Durasert E.
“Dosing the first patient in the Phase 2 VERONA
trial represents another significant milestone in advancing our
mission to improve the lives of patients with serious retinal
diseases. DME is a common sight-threatening complication of
diabetes that can lead to severe vision loss. It represents the
second diabetic eye disease indication that we are evaluating for
potential treatment using EYP-1901,” said Jay Duker, M.D.,
Chief Executive Officer of EyePoint Pharmaceuticals. “There is
a significant need for differentiated and longer-acting treatments
for DME patients, as the current standard of care requires frequent
intravitreal injections that are burdensome and can result in
under-treatment. We are encouraged by the growing body of clinical
data for EYP-1901 and we are optimistic that EYP-1901 has the
potential to change the current treatment paradigm for DME with
topline data expected in Q1 2025.”
Dr. Duker continued “We look forward to
announcing additional milestones for the EYP-1901 clinical programs
with topline data from the Phase 2 PAVIA clinical trial in
non-proliferative diabetic retinopathy expected in the second
quarter of 2024 and the initiation of the first Phase 3 pivotal
trial in wet age-related macular degeneration (wet AMD) anticipated
in the second half of 2024.”
VERONA is a randomized, controlled, single-masked,
Phase 2 trial of EYP-1901 in DME patients previously treated with a
standard-of-care anti-VEGF therapy. The three-arm trial is expected
to enroll approximately 25 patients assigned to one of two
intravitreal doses of EYP-1901 or an aflibercept control. The
primary efficacy endpoint of the VERONA trial is time to first
supplemental aflibercept injection up to 24 weeks based on
established supplement criteria. Secondary endpoints include
safety, change in best corrected visual acuity (BCVA), change in
central subfield thickness (CST) as measured by optical coherence
tomography (OCT), and change in diabetic retinopathy severity scale
(DRSS) over time. More information about the trial is available at
clinicaltrials.gov (identifier: NCT06099184).
About Diabetic Macular
Edema
Diabetic macular edema (DME) is the leading
cause of vision loss in people with type 1 and type 2 diabetes. DME
results when damaged blood vessels leak fluid into the macula, the
central portion of the retina responsible for the sharp vision
needed for routine tasks such as driving or reading. This resulting
retinal swelling can cause blurred vision and may lead to severe
vision loss or even blindness. DME is a common form of
sight-threatening retinopathy in people with diabetes, with
approximately 28 million people afflicted worldwide. As the
prevalence of diabetes continues to grow, an increased number of
people will be affected by diabetic eye diseases such as DME. The
current standard of care for patients experiencing DME include
intravitreal injections of short-acting anti-VEGF biologics,
corticosteroids, or laser photocoagulation which can become a
burden on patients, caregivers, and physicians due to the longevity
of the disease.
About EYP-1901
EYP-1901 is being developed as a potential
paradigm-altering treatment for patients suffering from
VEGF-mediated retinal diseases. EYP-1901 delivers vorolanib, a
selective and patent-protected tyrosine kinase inhibitor (TKI)
formulated in a solid bioerodible insert using EyePoint’s
proprietary sustained-release Durasert E™ technology. Vorolanib
brings a new mechanistic approach to the treatment of VEGF-mediated
retinal diseases as a pan-VEGF receptor inhibitor, inhibiting all
VEGF receptors. Further, in an in-vivo model of retinal detachment,
vorolanib demonstrated neuroprotection and antifibrotic benefits.
EYP-1901 is shipped and stored at ambient temperature and is
administered with a standard intravitreal injection in the
physician's office. EYP-1901 is immediately bioavailable, featuring
an initial burst of drug, followed by near constant zero-order
release kinetics for approximately nine months.
Positive data from both the Phase 1 DAVIO and
Phase 2 DAVIO 2 clinical trials of EYP-1901 in wet AMD demonstrated
clinically meaningful efficacy data with stable visual acuity and
OCT, and a favorable safety profile. Further, the recent DAVIO 2
data demonstrated an impressive treatment burden reduction of
approximately 88% at six-months, with over 80% of patients
supplement-free or receiving only one supplemental anti-VEGF
injection through up to 6 months. The data from the DAVIO 2
clinical trial supports the advancement of the wet AMD program to
Phase 3 pivotal trials which are anticipated to initiate in the
second half of 2024.
EYP-1901 is also being studied in
non-proliferative diabetic retinopathy and diabetic macular edema.
The Phase 2 PAVIA trial in NPDR is fully enrolled with topline data
anticipated in the second quarter of 2024.
About EyePoint
Pharmaceuticals
EyePoint Pharmaceuticals (Nasdaq: EYPT) is a
clinical-stage biopharmaceutical company committed to developing
and commercializing therapeutics to help improve the lives of
patients with serious retinal diseases. The Company's pipeline
leverages its proprietary bioerodible Durasert E™ technology for
sustained intraocular drug delivery. The Company’s lead product
candidate, EYP-1901, is an investigational sustained delivery
treatment for VEGF-mediated retinal diseases combining vorolanib, a
selective and patent-protected tyrosine kinase inhibitor with
Durasert E™. Additional pipeline programs include EYP-2301, a
promising TIE-2 agonist, razuprotafib, f/k/a AKB-9778, formulated
in Durasert E™ to potentially improve outcomes in serious retinal
diseases. The proven Durasert® drug delivery technology has been
safely administered to thousands of patient eyes across four U.S.
FDA approved products. EyePoint Pharmaceuticals is headquartered in
Watertown, Massachusetts.
Vorolanib is licensed to EyePoint exclusively by
Equinox Sciences for the localized treatment of all ophthalmic
diseases outside of China, Macao, Hong Kong and Taiwan.
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 and EYP-2301; the potential
for EYP-1901 as a novel sustained delivery treatment for serious
eye diseases, including wet age-related macular degeneration (wet
AMD) and non-proliferative diabetic retinopathy (NPDR) and diabetic
macular edema (DME); the effectiveness and timeliness of clinical
trials, and the usefulness of the data; the timeliness of
regulatory approvals including potential U.S. Food and Drug
Administration (FDA) regulatory approval of EYP-1901 and EYP-2301;
the success of current and future license agreements; our
dependence on contract research organizations, co-promotion
partners, and other outside vendors and service providers; the
success of Durasert® as a drug delivery platform in FDA approved
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 impact of general business and economic
conditions; protection of our intellectual property and avoiding
intellectual property infringement; retention of key personnel;
manufacturing risks; 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 ContactAmy PhillipsGreen
Room CommunicationsDirect:
412-327-9499aphillips@greenroompr.com
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