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 the initiation of its first
pivotal clinical trial to evaluate OTX-TKI, the Company’s axitinib
intravitreal implant, for the treatment of wet age-related macular
degeneration (wet AMD). OTX-TKI is also being developed for the
treatment of diabetic retinopathy and other retinal diseases.
"We are thrilled to announce the initiation of
our pivotal trial evaluating OTX-TKI for the treatment of wet AMD
and look forward to working with clinical sites across the US,"
said Antony Mattessich, CEO of Ocular Therapeutix. “With the
activation of our first clinical site in the US, we believe we are
on target to enroll our first subject before year end. The trial is
a crucial step forward for our clinical program as we make progress
toward our goal of bringing a transformative new treatment that can
truly make a difference for wet AMD to patients coping with vision
loss."
Ocular Therapeutix has requested a Special
Protocol Assessment (SPA) from the U.S. Food and Drug
Administration (FDA) regarding the design of the trial, which is
designed as a superiority trial that will enroll approximately 300
evaluable wet AMD subjects who are treatment naïve in the study
eye. The trial is designed to be a multi-center, parallel-group
trial that will be run primarily at U.S. sites with subjects
randomized to one injection of aflibercept or one implant of
OTX-TKI followed by as needed supplemental anti-VEGF treatment
based on pre-specified criteria. The safety and efficacy of OTX-TKI
will be assessed by measuring best corrected visual acuity (BCVA)
and central subfield thickness (CSFT) at 36 weeks. While this
institutional review board (IRB) approval has been received, the
Company does not intend to enroll a subject before the SPA feedback
is received from the FDA.
Arshad M. Khanani, MD, MA, FASRS, Director of
Clinical Research at Sierra Eye Associates in Reno, Nevada,
has agreed to be the principal investigator for the OTX-TKI pivotal
Phase 3 trial. Dr. Khanani is an internationally renowned retina
specialist with extensive experience in clinical trial design for
the treatment of age-related macular degeneration. He has served as
a principal investigator for numerous clinical trials evaluating
novel treatments for wet AMD and other retinal diseases.
“Anti-VEGF agents have revolutionized the treatment of wet AMD,
but numerous real-world patients experience vision loss due to
their inability to adhere to the demanding treatment regimen
involving frequent injections,” said Dr. Khanani. “OTX-TKI has
shown the potential to reduce treatment burden while maintaining
vision and anatomy for patients with wet AMD. The OTX-TKI pivotal
trial design is unique as it is based on the latest FDA guidance
for wet AMD. As a field, we must continue to push for the approval
of new therapies while making sure we appropriately manage our
patients who participate in these clinical trials. I look forward
to working with Ocular Therapeutix, the regulatory agency and the
retina community to harmonize regulatory endpoints with clinical
practice.”
David Brown, MD, FACS, a renowned leader in the retina
community, is the co-chairman of the medical leadership board at
Retina Consultants of America (RCA) which has agreed to participate
in the trial. Dr. Brown has pioneered research and treatment in
retina, publishing more than 300 national meeting presentations,
abstracts and scientific papers, including many of the primary
papers that established the use of anti-VEGF agents for AMD,
diabetic retinopathy and retinal vein occlusion.
“This pivotal trial is thoughtfully designed to satisfy the
FDA’s latest guidance in wet AMD, while also balancing the needs of
subjects who enter it,” said Dr. Brown. “The sites at RCA are
excited to be a part of the OTX-TKI program as we continue our
mission to develop better treatments for patients in the fight
against retinal blindness.”
The pivotal trial was initiated based on the
previously announced positive 12-month top-line data from the
Company’s 21-subject U.S.-based Phase 1 trial of OTX-TKI for
the treatment of wet AMD. Data from this trial were presented at
the Clinical Trials at the Summit 2023 Meeting held in Park
City, Utah in June 2023. In that trial, subjects treated
with a single implant of OTX-TKI were observed to have an 89%
reduction in treatment burden compared to subjects treated with
aflibercept while maintaining visual acuity and retinal thickness
through 12 months. Subjects in the OTX-TKI arm had mean changes
from baseline of -1.0 letters in BCVA and +20.2 μm in CSFT at 12
months, comparable to mean changes from baseline for subjects in
the aflibercept arm of +2.0 letters and -2.2 μm. 60% of OTX-TKI
subjects remained rescue-free up to 12 months. As of the April 14,
2023 data cut-off date, no drug-related ocular or systemic serious
adverse events through 12 months were observed in the OTX-TKI
arm.
About OTX-TKIOTX-TKI 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 age-related macular degeneration (wet AMD) and other retinal
diseases.
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 a Phase 1 clinical
trial for the treatment of diabetic retinopathy and a pivotal Phase
3 trial for wet AMD; 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 and design
of the Company’s pivotal trials of OTX-TKI for the treatment of wet
AMD; the Company’s plans to advance the development of OTX-TKI; 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, including the conduct of
post-approval studies; 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 first pivotal trial of OTX-TKI for the
treatment of wet AMD; uncertainties as to the response from the FDA
regarding the SPA submission for OTX-TKI, including the risk that
the FDA will not agree with the design of the first pivotal trial
under the SPA; the risk that even if the FDA agrees with the design
of the first pivotal trial under the SPA, the FDA will not agree
that the data generated by the trial could support 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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