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, today announced that the first three
subjects have been screened and received their first aflibercept
injection in the Phase 3 SOL-1 clinical trial of AXPAXLI™ (axitinib
intravitreal implant, also known as OTX-TKI) for the treatment of
wet age-related macular degeneration (wet AMD). The Company
previously announced FDA agreement on its Special Protocol
Assessment (SPA) Agreement Modification on January 25th.
“The screening of these subjects in the pivotal Phase 3 SOL-1
trial of AXPAXLI marks an exciting milestone for Ocular
Therapeutix,” said Antony Mattessich, CEO of Ocular Therapeutix.
“AXPAXLI has demonstrated promising durability, biological
activity, and a favorable safety profile in earlier studies. We
believe that AXPAXLI could set a new standard in wet AMD therapy by
significantly extending time between treatments. If successful,
this first-of-its-kind implant could reduce injection burden for
patients and doctors alike while leading to better long-term
outcomes.”
“Wet AMD patients need options that provide sustained therapy
while minimizing their need for frequent injections and office
visits,” said Allen Hu, M.D., a principal investigator in the SOL
study and vitreoretinal surgeon at Cumberland Valley Retina
Consultants. “I am thrilled to be participating in research that
could shift the existing treatment paradigm for patients with wet
AMD.” Dr. Hu is an active principal investigator of innovative
technologies for the treatment of macular degeneration, diabetic
retinopathy and retinal vascular disorders, having participated in
over 40 clinical trials over the past 10 years.
“Clinical trials like the SOL-1 study for AXPAXLI represent a
critical step forward in our pursuit of more patient-centric
treatments for wet AMD. As a clinician dedicated to advancing
retinal care, I am excited to contribute to the development of
potentially transformative solutions for our patients,” said
Dilsher Dhoot, M.D., a principal investigator in the SOL-1 study
and vitreoretinal surgeon at California Retina Consultants. Dr.
Dhoot has contributed to over 35 clinical trials in the past decade
as an active principal investigator, pioneering new approaches in
advancing the field of retinal therapies.
About AXPAXLIAXPAXLI is an investigational
bioresorbable, hydrogel implant incorporating axitinib, a small
molecule, multi-target, tyrosine kinase inhibitor with
anti-angiogenic properties, being evaluated for the treatment of
wet AMD and other retinal diseases.
About Wet AMDWet age-related macular
degeneration (wet AMD) is a leading cause of severe, irreversible
vision loss affecting approximately 14 million individuals globally
and 1.6 million in the United States alone (2022 Market Scope®
Retinal Pharmaceuticals Market Report). Wet AMD causes vision loss
due to abnormal new blood vessel growth and hyperpermeability and
associated retinal vascularity in the macula, which is primarily
stimulated by local upregulation of vascular endothelial growth
factor (VEGF). Without prompt and continuous treatment to control
this exudative activity, patients develop irreversible vision loss.
With proper treatment, patients may maintain visual function for a
period of time and may temporarily regain lost vision. Challenges
with current therapies include repeated intraocular injections
every 1 to 4 months, treatment-related adverse events, patient
compliance, and lack of vision improvement.
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
ELUTYX™. 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: AXPAXLI
(axitinib intravitreal implant), currently in a pivotal Phase 3
trial for the treatment of wet AMD and a Phase 1 clinical trial for
the treatment of diabetic retinopathy; PAXTRAVA™ (travoprost
intracameral implant, also known as OTX-TIC), 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.
Forward Looking StatementsAny statements in
this press release about future expectations, plans, and prospects
for the Company, including the development and regulatory status of
the Company’s product candidates, including the timing, design, and
enrollment of the Company’s pivotal trials of AXPAXLI (also called
OTX-TKI) for the treatment of wet AMD; the Company’s plans to
advance the development of AXPAXLI; 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 or any product or product candidate
that receives regulatory approval; the ability to retain regulatory
approval of DEXTENZA or any product or 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, design, timing, conduct and outcomes
of clinical trials, including the SOL-1 trial; the risk that the
FDA will not agree with the Company’s interpretation of the written
agreement under the SPA; the risk that even though the FDA has
agreed with the overall design of the SOL-1 trial, the FDA may not
agree that the data generated by the SOL-1 trial supports potential
marketing approval; uncertainty as to whether the data from earlier
clinical trials will be predictive of the data of later clinical
trials, particularly later clinical trials that have a different
design or utilize a different formulation than the earlier trials;
availability of data from clinical trials and expectations for
regulatory submissions and approvals; the Company’s scientific
approach and general development progress; uncertainties inherent
in estimating the Company’s cash runway, future expenses and other
financial results, including its ability to fund future operations,
including clinical trials; Company’s existing indebtedness and the
ability of the Company’s creditors to accelerate the maturity of
such indebtedness upon the occurrence of certain events of default;
the Company’s ability to enter into strategic alliances or generate
additional funding on a timely basis, on favorable terms, or at
all; 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.
InvestorsOcular TherapeutixDonald NotmanChief
Financial Officerdnotman@ocutx.com
or
ICR WestwickeChris Brinzey, 339-970-2843Managing
Directorchris.brinzey@westwicke.com
MediaICR WestwickeBen Shannon,
443-213-0495ben.shannon@westwicke.com
Grafico Azioni Ocular Therapeutix (NASDAQ:OCUL)
Storico
Da Ago 2024 a Set 2024
Grafico Azioni Ocular Therapeutix (NASDAQ:OCUL)
Storico
Da Set 2023 a Set 2024