Peter K. Kaiser, M.D., a world-renowned
ophthalmologist and retinal disease expert, to serve as Chief
Medical Advisor – Retina
Rabia Gurses Ozden, M.D. promoted to Chief
Medical Officer
Michael Goldstein, M.D. to transition from
Chief Medical Officer and President Ophthalmology to Chief Strategy
Advisor
Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical
company focused on the formulation, development, and
commercialization of innovative therapies for diseases and
conditions of the eye, announced senior leadership changes to
strengthen the Company’s alignment around the development of its
late-stage ophthalmology product portfolio. The realignment was
affected to enhance Ocular’s ability to execute its strategy of
building a comprehensive portfolio of assets to treat a broad range
of ocular surface and back-of-the-eye retina diseases.
The Company has announced that Peter K. Kaiser, M.D. has agreed
to advise the Company in a newly created role of Chief Medical
Advisor, Retina. In this role, Dr. Kaiser will advise on clinical
development strategies for Ocular Therapeutix’s retina programs
including OTX-TKI, currently in Phase 1 development in the United
States and Australia for the treatment of wet age-related macular
degeneration (wet AMD) and other retinal diseases. Dr. Kaiser is
also expected to advise on pre-clinical development work for
Ocular’s gene therapy delivery and complement inhibition
development programs. Dr. Kaiser has agreed to serve in this role
on a part time consulting basis while continuing as Chaney Family
Endowed Chair in Ophthalmology Research and Professor of
Ophthalmology at the Cleveland Clinic Lerner College of Medicine
and Cole Eye Institute.
Rabia Gurses Ozden, M.D., currently serving as the Company’s
Senior Vice President, Clinical Development, has been promoted to
the role of Chief Medical Officer, effective July 1, 2022, to lead
the clinical development of Ocular Therapeutix’s current and
growing pipeline of programs focusing on the front and back of the
eye. Dr. Gurses Ozden has 15 years of experience in clinical
development, clinical operations, and pharmacovigilance in
pharmaceutical and medical device development with proven
capabilities in global program and project management as well as
experience interacting with the FDA, EMA, PMDA, and CFDA for
regulatory filings, and new clinical endpoint development. Prior to
joining Ocular in 2021, Dr. Gurses Ozden served as the Chief
Development Officer at Akouos, Inc. Previously, she served as Chief
Medical Officer of Nightstar Therapeutics plc, a gene therapy
company focused on rare inherited retinal diseases that was
acquired by Biogen.
Michael Goldstein, M.D., currently serving as Chief Medical
Officer, President of Ophthalmology will depart from the Company to
pursue additional business interests outside of the Company on June
30, 2022, but he has agreed to continue to work with the Company
part-time as a consultant in a newly created role of Chief Strategy
Advisor where he will continue to be available to assist with
pipeline development activities.
“I am thrilled to be expanding our development capabilities with
the addition of Dr. Kaiser as we advance our portfolio of
innovative ophthalmic therapies for both front and back of the eye
diseases,” said Antony Mattessich, President and Chief Executive
Officer. “Having someone of Dr. Kaiser’s caliber contributing to
the great work we are already doing on the retina programs is
extremely exciting. His extensive knowledge and experience should
have an immediate impact as we finalize plans to advance OTX-TKI
into Phase 2 clinical development. We are developing this product
candidate to set the standard of care for durability in the
treatment of wet AMD.”
Mr. Mattessich continued: “I am also pleased to be announcing
the promotion of Dr. Rabia Gurses Ozden to the role of Chief
Medical Officer. Since joining Ocular last year, Rabia has built a
clinical team second-to-none in the ophthalmology space and
demonstrated an insightful enterprise mindset as a member of the
Senior Leadership Team. In her expanded role, Rabia will also
assume responsibility for regulatory and medical affairs as she
joins the C-suite at Ocular and succeeds Dr. Michael Goldstein who
has agreed to continue to work with us as a consultant as Chief
Strategy Advisor. I am deeply grateful to Mike for his many
contributions in the building of Ocular Therapeutix over these past
five years and am extremely pleased that we will continue to get
the benefits of his strategic insights on our product
opportunities.”
“I could not be more thrilled to be joining Ocular and working
with such a dynamic management team,” commented Peter K. Kaiser,
M.D. “The Company’s lead program, OTX-TKI, has already demonstrated
compelling results with a promising safety profile, a preliminary
signal of biological activity, and durability that could change the
standard of care for patients with wet AMD. I believe the same
potential exists for application of the Company’s hydrogel
technology to other modalities like gene therapy and products used
to treat a wide variety of retinal diseases. I look forward to
collaborating with Rabia, Mike and the rest of the Ocular team to
bring the Company’s retinal programs forward.”
About Peter K. Kaiser, MD
Dr. Kaiser is a world-renowned ophthalmologist and researcher
with over 25 years of experience in leading ophthalmology roles
across the field including in academic, research, clinical and
business settings. Dr. Kaiser currently works in the vitreoretinal
department of the Cole Eye Institute at the Cleveland Clinic
Foundation, Cleveland, Ohio where he is the Chaney Family Endowed
Professor of Ophthalmology Research at the Cleveland Clinic Lerner
College of Medicine. Dr. Kaiser has been honored to receive the Lew
R. Wasserman Award from the Research to Prevent Blindness and the
Macula Society’s Young Investigator Award. Complementing his
research endeavors, Dr. Kaiser serves on numerous scientific
advisory boards and addresses his research interests as an invited
speaker at national and international conferences. He is a major
contributor to the medical literature having authored 7 textbooks,
30 book chapters, and more than 400 peer-reviewed manuscripts. He
is Editor-in-Chief of Retinal Physician, Associate Editor of
International Ophthalmology Clinics, and serves on the editorial
boards of American Journal of Ophthalmology, Retina, Retina Today,
and Ocular Surgery News. Dr. Kaiser has been recognized with the
American Society of Retina Specialists Honor and Senior Honor
Awards, along with the American Academy of Ophthalmology
Achievement, Senior Achievement, and Lifetime Achievement Awards.
He has been named one of the 150 Top Innovators in Retina by Ocular
Surgery News, selected as a charter inductee of the Retina Hall of
Fame in 2017, and appeared on The Ophthalmologist’s Power List 2018
and 2020 as one of the top 100 most influential people in the world
of ophthalmology.
Dr. Kaiser graduated magna cum laude with Highest Honors from
Harvard College and magna cum laude from Harvard Medical School. He
completed an internal medicine internship at Massachusetts General
Hospital, an ophthalmology residency at the Massachusetts Eye and
Ear Infirmary, and a vitreoretinal fellowship at Bascom Palmer Eye
Institute.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company focused
on the formulation, development, and commercialization of
innovative therapies for diseases and conditions of the eye using
its proprietary bioresorbable hydrogel-based formulation
technology. Ocular Therapeutix’s first commercial drug product,
DEXTENZA®, is an FDA-approved corticosteroid for the treatment of
ocular inflammation and pain following ophthalmic surgery and
ocular itching associated with allergic conjunctivitis. Ocular
Therapeutix’s earlier stage development assets include: OTX-TKI
(axitinib intravitreal implant), currently in Phase 1 clinical
trials for the treatment of wet AMD and other retinal diseases;
OTX-TIC (travoprost intracameral implant), currently in a Phase 2
clinical trial for the treatment of primary open-angle glaucoma or
ocular hypertension; and OTX-CSI (cyclosporine intracanalicular
insert) for the chronic treatment of dry eye disease and OTX-DED
(dexamethasone intracanalicular insert) for the short-term
treatment of the signs and symptoms of dry eye disease, both of
which have completed Phase 2 clinical trials. Ocular Therapeutix's
first product, ReSure® Sealant, is an FDA-approved device to
prevent wound leaks in corneal incisions following cataract
surgery.
Forward Looking Statements
Any statements in this press release about future expectations,
plans, and prospects for the Company, including the
commercialization of DEXTENZA®, ReSure® Sealant, or any of the
Company’s product candidates; the development and regulatory status
of the Company’s product candidates, such as the Company’s
development of and prospects for approvability of OTX-CSI for the
chronic treatment of dry eye disease, OTX-DED for the short-term
treatment of the signs and symptoms of dry eye disease, OTX-TIC for
the treatment of primary open-angle glaucoma or ocular
hypertension, and OTX-TKI for the treatment of retinal diseases
including wet AMD; the Company’s plans to advance the development
of its product candidates; the ongoing development of the Company’s
extended-delivery hydrogel depot technology; the potential utility
of any of the Company’s product candidates; the expected impact of
the changes in the Company’s senior leadership and other statements
containing the words "anticipate," "believe," "estimate," "expect,"
"intend", "goal," "may", "might," "plan," "predict," "project,"
"target," "potential," "will," "would," "could," "should,"
"continue," and similar expressions, constitute forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors. Such forward-looking statements involve
substantial risks and uncertainties that could cause the Company’s
preclinical and clinical development programs, future results,
performance or achievements to differ significantly from those
expressed or implied by the forward-looking statements. Such risks
and uncertainties include, among others, the timing and costs
involved in commercializing DEXTENZA, ReSure Sealant or any product
candidate that receives regulatory approval, including the conduct
of post-approval studies, the ability to successfully develop and
commercialize products for the ophthalmology office setting, the
ability to retain regulatory approval of DEXTENZA, ReSure Sealant
or any product candidate that receives regulatory approval, the
ability to maintain and the sufficiency of product, procedure and
any other reimbursement codes for DEXTENZA, the initiation, timing,
conduct and outcomes of clinical trials, whether clinical trial
data such as the data reported in this release will be indicative
of the results of subsequent clinical trials, availability of data
from clinical trials and expectations for regulatory submissions
and approvals, the Company’s ability to enter into and perform its
obligations under collaborations and the performance of its
collaborators under such collaborations, the Company’s scientific
approach and general development progress, the availability or
commercial potential of the Company’s product candidates, the
Company’s ability to meet supply demands, the Company’s ability to
generate its projected net product revenue and in-market sales on
the timeline expected, if at all, the sufficiency of cash
resources, the Company’s existing indebtedness, the ability of the
Company’s creditors to accelerate the maturity of such indebtedness
upon the occurrence of certain events of default, the severity and
duration of the COVID-19 pandemic including its effect on the
Company’s revenues and relevant regulatory authorities’ operations,
any additional financing needs, the Company’s ability to recruit
and retain key personnel, and other factors discussed in the “Risk
Factors” section contained in the Company’s quarterly and annual
reports on file with the Securities and Exchange Commission. In
addition, the forward-looking statements included in this press
release represent the Company’s views as of the date of this press
release. The Company anticipates that subsequent events and
developments will cause the Company’s views to change. However,
while the Company may elect to update these forward-looking
statements at some point in the future, the Company specifically
disclaims any obligation to do so, whether as a result of new
information, future events or otherwise, except as required by law.
These forward-looking statements should not be relied upon as
representing the Company’s views as of any date subsequent to the
date of this press release.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220608005369/en/
Investors Ocular Therapeutix Donald Notman Chief
Financial Officer dnotman@ocutx.com
or
ICR Westwicke Chris Brinzey, 339-970-2843 Managing Director
chris.brinzey@westwicke.com
Media Ocular Therapeutix Scott Corning Senior Vice
President, Commercial scorning@ocutx.com
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