Ocular Therapeutix™ Receives FDA Agreement Under Special Protocol Assessment (SPA) for its First Pivotal Clinical Trial of OTX-TKI in Wet AMD
01 Novembro 2023 - 9:00AM
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 it had received written
agreement regarding the overall design from the U.S. Food and Drug
Administration (FDA) under a Special Protocol Assessment (SPA) for
the Company’s ongoing pivotal Phase 3 clinical trial for AXPAXLI
(axitinib intravitreal implant), for the treatment of wet
age-related macular degeneration (wet AMD), which the Company
refers to as the SOL trial.
The Company initiated the SOL trial in September 2023 and
expects to enroll approximately 300 evaluable wet AMD subjects who
are treatment naïve in the study eye in the trial. The SOL trial is
designed to be a multi-center, parallel-group trial run primarily
at U.S. sites, with subjects randomized to one injection of
aflibercept or one implant of AXPAXLI followed by supplemental
anti-VEGF treatment based on pre-specified criteria. With the
agreement under the SPA, the Company will begin enrolling patients
in the SOL trial and expects to dose the first subject by
year-end.
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. AXPAXLI is also referred to by
its laboratory code, OTX-TKI.
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 wet AMD and a Phase 1 clinical trial for the treatment of
diabetic retinopathy; 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.
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; the Company’s cash runway and
sufficiency of the Company’s cash resources; 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 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 trial, the FDA may not
agree that the data generated by the SOL 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 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.comorICR WestwickeChris Brinzey,
339-970-2843Managing Directorchris.brinzey@westwicke.com
MediaICR WestwickeBen Shannon,
443-213-0495ben.shannon@westwicke.com
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