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 the
appointment of leading global ophthalmologists to its Scientific
Advisory Board (SAB), co-chaired by Carl Regillo M.D., FACS, Chief
of the Retina Service at Wills Eye Hospital and Charles Wykoff,
M.D., Ph.D., Director of Research of Retina Consultants of Texas.
The SAB additions include Usha Chakravarthy, M.B.B.S., Ph.D.; Allen
Ho, M.D. FACS FASRS, and Frank Holz, M.D., F.E.B.O., F.A.R.V.O.
These three world-renowned retinal specialists will support
advancement of the Company’s global clinical strategy ahead of the
anticipated initiation of its Phase 3 pivotal trials in wet
age-related macular degeneration (wet AMD) in the second half of
this year. Additionally, the Company announced that the U.S. Food
and Drug Administration (FDA) has conditionally accepted the trade
name, DURAVYUTM (vorolanib intravitreal insert) for the Company’s
lead product candidate, EYP-1901.
“We are honored to add these prominent leaders
of the retina community to our SAB as we approach the topline data
readout of the Phase 2 PAVIA trial for non-proliferative diabetic
retinopathy later this quarter, and as we prepare for the
initiation of our global Phase 3 program in the second half of
2024,” said Ramiro Ribeiro, M.D., Ph.D., Chief Medical Officer of
EyePoint. “The SAB’s strategic counsel, global expertise, and
scientific knowledge will be incredibly valuable during this
critical time in EyePoint’s growth and expansion. The caliber of
our expanded SAB speaks to the quality and potential of our
programs, and I look forward to this collaboration to further
expand our product candidates and to bring novel treatment options
to patients globally.”
“We are delighted to announce that ‘DURAVYU’ has
been conditionally accepted as a proprietary name by the FDA for
our lead product candidate, EYP-1901,” said Jay S. Duker, M.D.,
President and Chief Executive Officer of EyePoint. “This represents
another step forward as we continue to advance DURAVYU through
clinical development across three significant sight-threatening
indications in our efforts to bring a safe and effective therapy
with the potential to improve the treatment paradigm for
patients.”
“Following EyePoint’s strong and convincing
Phase 2 DAVIO 2 data for DURAVYU in wet AMD, I am delighted to have
these distinguished leaders on the cutting edge of ophthalmic
research join the SAB,” said Carl Regillo, M.D., FACS, Co-Chair of
EyePoint’s SAB. “I look forward to collaborating with Dr. Wykoff in
his expanded role, as well as the renowned members of the SAB and
EyePoint management team, as we work to improve the lives of
patients with serious retinal diseases.”
Usha Chakravarthy, M.B.B.S.,
Ph.D.Usha Chakravarthy, M.B.B.S., Ph.D. is an Honorary and
Emerita Professor of Ophthalmology and Vision Sciences at the
Queen’s University of Belfast. She is recognized internationally
for her work on age-related macular degeneration (AMD) and diabetic
retinopathy. Dr. Chakravarthy has authored or co-authored over 400
publications, and she is invited to lecture in the UK and abroad.
She has been involved in many of the major international retina
clinical trials as well as co-authored Cochrane Review articles and
guidelines for the Royal College of Ophthalmologists on the
treatment of AMD. Dr. Chakravarthy has been the recipient of many
prestigious awards including the title of Commander in the Most
Excellent Order of the British Empire for clinical services to
ophthalmology and research. She holds a Ph.D. from Queen’s
University of Belfast and an M.B.B.S. from the University of
Madras.
Allen Ho, M.D., FACS
FASRSAllen Ho, M.D. FACS FASRS is Attending Surgeon,
Director of Retina Research and Co-Director of the Retina Service
of Wills Eye Hospital and Professor of Ophthalmology at Thomas
Jefferson University. He has deep experience in translational
clinical research and maintains special interests in macular
diseases, diabetic retinopathy, surgical retinal diseases and
clinical trials, investigating new treatments for vitreoretinal
diseases. Dr. Ho has authored over 300 peer reviewed publications
and several textbooks. He has been a principal investigator on
numerous major clinical trials developing new medical and surgical
treatments for retinal disorders. Dr. Ho is the recipient of
numerous awards including from the American Academy of
Ophthalmology, multiple retina societies and the American Diabetes
Association, and he is a perennial awardee of national Castle
Connolly awards. He was also named in the Ophthalmologist Power
List of the top 100 most influential ophthalmologists in the world.
Dr. Ho holds an M.D. from Columbia University College of Physicians
and Surgeons and a B.A. from Cornell University.
Frank Holz, M.D., F.E.B.O.,
F.A.R.V.O.Frank Holz, M.D., F.E.B.O., F.A.R.V.O. is a
professor and chairman of the Department of Ophthalmology at the
University of Bonn in Germany. He founded the Medical Imaging
Center Bonn (MIB), the GRADE Reading Center Bonn and was a
co-founder of the Priority Program AMD of the German Research
Council. He has published over 600 articles in peer-reviewed
journals and has authored or co-authored more than 20 book chapters
on age-related macular degeneration, medical retina and retinal
imaging. Dr. Holz is the recipient of multiple local, national and
international awards including the Pro Retina Macular Degeneration
Research Award, the Leonhard-Klein Award for Ocular Surgery, the
Alcon Research Institute (ARI) Award, the Senior Achievement Award
of the AAO and the Jules Gonin Award. He is a Board Member
of the German Ophthalmological Society, and of the Club Jules
Gonin and is past president of EURETINA. Dr. Holz trained at the
University of Heidelberg, the University of Chicago Pritzker
School of Medicine and completed a fellowship at Moorfields
Eye Hospital, London.
DURAVYU™ has been conditionally accepted by the
FDA as the proprietary name for EYP-1901. DURAVYU is an
investigational product; it has not been approved by the FDA. FDA
approval and the timeline for potential approval is uncertain.
About EyePoint
PharmaceuticalsEyePoint 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 (DURYVU™), is an investigational sustained
delivery treatment for VEGF-mediated retinal diseases combining
vorolanib, a selective and patent-protected tyrosine kinase
inhibitor with Durasert E™. 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, a Betta Pharmaceuticals affiliate, 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
statements about the sufficiency of our existing cash resources
through topline data for Phase 3 clinical trials for EYP-1901
(DURAVYU™) in wet AMD; our expectations regarding the timing and
clinical development of our product candidates, including DURAVYU
and EYP-2301; the potential for DURAVYU 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 DURAVYU 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 Contact:Amy PhillipsGreen
Room CommunicationsDirect:
412-327-9499aphillips@greenroompr.com
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