EyePoint Pharmaceuticals Investor Day to Highlight EYP-1901 and Durasert® Technology Developments and Provide a Financial Update
July 18 2022 - 7:30AM
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 the Company will highlight historical and ongoing
developments for its lead pipeline program, EYP-1901 and its
Durasert platform technology, and will also provide a financial
update during its Investor Day today, Monday, July 18, 2022, from
8:00 a.m. to 11 a.m. ET.
“EyePoint is helping to change the treatment paradigm of wet AMD
using a ‘treat to maintain’ maintenance therapy approach with
EYP-1901, an investigational sustained delivery anti-VEGF
treatment,” said Nancy Lurker, Chief Executive Officer of EyePoint
Pharmaceuticals. “We are excited to share updated pre-clinical and
human data for EYP-1901 during our Investor Day, along with the
12-month DAVIO Phase 1 clinical trial data, which we just released
last week at the American Society of Retinal Surgeons (ASRS) Annual
Meeting.”
Investor Day will feature commentary from EyePoint’s management
team as well as key opinion leader guest speakers, Carl D.
Regillo, M.D., FACS, Professor of Ophthalmology, Thomas
Jefferson University and Charles C. Wykoff, M.D., Ph.D.,
Director of Research, Retina Consultants of Texas.
Investor Day Highlights:
- Nancy Lurker, Chief Executive
Officer will present an overview of the Company.
- Jay Duker M.D., Chief Operating
Officer will present an overview of EYP-1901 using a bioerodible
formulation of EyePoint’s proprietary Durasert® technology for
sustained intraocular drug delivery, which has been safely
administered to over 80,000 patients’ eyes across four U.S. FDA
approved products.
- Said Saim, Ph.D., Chief Technology
Officer, will present an overview of EYP-1901 preclinical data,
including its development and formulation and new pre-clinical data
highlighting neuroprotection potential for EYP-1901.
- Carl Regillo, M.D., FACS, Professor
of Ophthalmology, Thomas Jefferson University, will present
the 12-month safety and efficacy data from the Phase 1 DAVIO
clinical trial evaluating EYP-1901 for the potential treatment of
wet AMD that showed continued positive safety and efficacy for
EYP-1901 including no serious ocular adverse events and 35% of
patients out to 12 months with no supplemental anti-VEGF treatment
after the initial EYP-1901 insert was administered.
- Charles Wykoff, M.D., Ph.D.,
Director of Research, Retina Consultants of Texas, and Jay
Duker M.D., Chief Operating Officer, will discuss the
potential opportunity of EYP-1901 as a “treat to maintain”
maintenance therapy for wet AMD.
- Dario Paggiarino, M.D., Chief
Medical Officer will present the EYP-1901 Phase 2 plans in wet AMD
and NPDR with first patient dosing anticipated in Q3 2022. He will
also provide an update on two ongoing Phase 4 studies for YUTIQ®,
(fluocinolone acetonide intravitreal implant) 0.18 mg, for the
treatment of chronic, non-infectious uveitis affecting the
posterior segment of the eye.
- George Elston, Chief Financial
Officer, will provide a financial update on Q2 2022 performance
with net product revenue of $11.3 million for the quarter and cash
and investments of $171 million at June 30, 2022. He will also
discuss the potential impact of the 2023 CMS Draft HOPPS (Hospital
Outpatient) rule released last week in which CMS has indicated its
intention not to provide further pass-through extension to expiring
products, including DEXYCU. If the draft rule becomes final, DEXYCU
will lose pass-through separate reimbursement status on December
31, 2022 and will instead be bundled into the general Cataract
procedure reimbursement code starting on January 1, 2023.
The preliminary second quarter 2022 revenue results and cash and
investments on hand included in this release were calculated prior
to the completion of a review by the Company’s independent
registered public accounting firm and are therefore subject to
adjustment.
Investor Day Webcast Information
A webcast and subsequent archived replay of the presentation may
be accessed via the Investors section of the Company website at
www.eyepointpharma.com. The replay will be available for 90 days
after the event.
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. Phase 2 clinical trials
for wet AMD (DAVIO 2) and non-proliferative diabetic
retinopathy are expected to begin dosing patients in Q3 2022. A
Phase 2 clinical trial is 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 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
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 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 TartagliaStern IRDirect:
212-698-8700christina.tartaglia@sternir.com
Media Contact
Amy PhillipsGreen Room CommunicationsDirect:
412-327-9499aphillips@greenroompr.com
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