Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”, the “Company”), a
biopharmaceutical company committed to improving vision in the real
world through the development and commercialization of innovative
therapies for retinal diseases and other eye conditions, today
announced that the first patients have been enrolled in the Phase 3
SOL-R clinical trial evaluating repeat dosing of AXPAXLI™ (axitinib
intravitreal implant, also known as OTX-TKI) for the treatment of
patients with wet age-related macular degeneration (wet AMD).
SOL-R is a global, 825-patient, non-inferiority study evaluating
repeat dosing of AXPAXLI every six months (Q6M) compared to 2 mg
aflibercept, dosed every eight weeks (Q8W) in patients with wet
AMD. A third arm evaluating 8 mg aflibercept dosed Q6M is
incorporated to ensure the study is adequately masked. The trial is
evaluating AXPAXLI versus the current standard of care under the
“real world” requirements of a repeat-dosing regimen.
“Our first Phase 3 trial, SOL-1, is intended to show that
AXPAXLI can safely and durably maintain visual acuity in patients
with wet AMD. SOL-R is intended to build on that by providing
physicians with important evidence regarding the potential to
re-dose AXPAXLI every six months, which better aligns with a likely
‘real world’ experience,” said Pravin U. Dugel, MD,
Executive Chairman, President and Chief Executive Officer
of Ocular Therapeutix. “SOL-R will initially enroll patients who do
not qualify to be randomized in SOL-1. Subsequently, SOL-R will be
opened to direct enrollment of patients who are treatment naïve or
diagnosed with wet AMD within three months prior to enrollment.
Patients enrolled in SOL-R are similar to those enrolled in our
successful U.S. Phase 1 study, with further enrichment through
multiple aflibercept loading doses. Further, these patients are
evaluated to limit retinal fluid fluctuations between visits prior
to randomization, increasing our confidence in the study’s
potential success.”
“There is increasing evidence that pulsatile VEGF suppression
may result in OCT fluctuations that could lead to poor long term
visual outcomes. Even with new therapeutics entering the wet AMD
market, the need for a durable and sustained treatment is
substantial for many of my patients. The SOL-R study is critically
important because results from this large, repeat-dosing study may
provide the retina community with insight on how AXPAXLI may be
used in our practices,” said Arshad M. Khanani, MD, MA,
FASRS, Director of Clinic Research at Sierra Eye Associates, Reno,
Nevada. “Providing patients who do not qualify for SOL-1
randomization with an opportunity to enroll in the SOL-R study is a
tremendous service to physicians and the patients they serve.
Moreover, I appreciate that SOL-R is designed for AXPAXLI
re-treatment at six months, which is in-line with how often I’d
ideally like to see my wet AMD patients. That said, it is not
uncommon to reschedule appointments, leaving more time in between
visits. Fortunately, SOL-1 is designed to generate valuable
evidence to determine the ultimate durability of a single AXPAXLI
implant. Together, these trials aim to provide a comprehensive
picture of the flexibility of dosing intervals to meet individual
patient needs.”
About AXPAXLIAXPAXLI™ (axitinib intravitreal
implant, also known as OTX-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 AMD, diabetic retinopathy and other retinal diseases.
About the SOL-R studyThe Phase 3 SOL-R trial
(NCT06495918) is designed to evaluate the safety and efficacy of
AXPAXLI in a multi-center, double-masked, randomized (2:2:1),
three-arm study that will involve sites located in the U.S. and the
rest of the world. The trial is intended to randomize approximately
825 patients who are treatment naïve or diagnosed with wet AMD in
the study eye within three months prior to enrollment.
The one-year, non-inferiority study reflects a patient
enrichment strategy that includes multiple loading doses of
aflibercept and monitoring to exclude those with significant
retinal fluid fluctuations. In the first arm, patients will be
randomized to receive a single dose of AXPAXLI at Day 1 and
re-dosed at Week 24. In the second arm, patients will receive
aflibercept (2 mg) on-label every 8 weeks. In a third arm, patients
will receive a single dose of aflibercept (8 mg) at Day 1 and
re-dosed at Week 24, aligned to the AXPAXLI treatment arm for
adequate masking. Subjects in any arm meeting pre-specified rescue
criteria will receive a supplemental dose of aflibercept.
The primary endpoint is non-inferiority in mean best corrected
visual acuity (BCVA) change from baseline between the AXPAXLI and
on-label aflibercept (2 mg) arms at one year.
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 1.65 million in the United States alone (2023 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
pulsatile, repeated intraocular injections, treatment-related
adverse events and up to 40% patient discontinuation with continued
disease progression. Taken together, these factors lead to
undertreatment and a lack of vision improvement for patients.
About Ocular Therapeutix, Inc.Ocular
Therapeutix, Inc. is a biopharmaceutical company committed to
improving vision in the real world through the development and
commercialization of innovative therapies for retinal diseases and
other eye conditions. AXPAXLI™ (axitinib intravitreal implant, also
known as OTX-TKI), Ocular’s lead product candidate for retinal
disease, is based on its ELUTYX™ proprietary bioresorbable
hydrogel-based formulation technology. AXPAXLI is currently in
Phase 3 clinical trials for wet age-related macular degeneration
(wet AMD).
Ocular’s pipeline also leverages the ELUTYX technology in its
commercial product DEXTENZA®, an FDA-approved corticosteroid for
the treatment of ocular inflammation and pain following ophthalmic
surgery and ocular itching associated with allergic conjunctivitis,
and in its product candidate PAXTRAVA™ (travoprost
intracameral implant or OTX-TIC), which has completed a Phase 2
clinical trial for the treatment of open-angle glaucoma or ocular
hypertension.
Follow us on our website, LinkedIn, or X.
The Ocular Therapeutix logo and DEXTENZA® are registered
trademarks of Ocular Therapeutix, Inc. AXPAXLI™, PAXTRAVA™,
ELUTYX™, and Ocular Therapeutix™ are trademarks of Ocular
Therapeutix, Inc.
Forward-Looking Statements:Any 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; the timing, design, and
enrollment of the Company’s SOL-1 Phase 3 clinical trial of AXPAXLI
(also called OTX-TKI) for the treatment of wet AMD; the timing,
design, and enrollment of the Company’s SOL-R Phase 3 clinical
trial of AXPAXLI; the Company’s plans to advance the development of
AXPAXLI and its other product candidates; the potential utility of
any of the Company’s product candidates; 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 initiation, design, timing,
conduct and outcomes of ongoing and planned clinical trials; the
risk that the FDA will not agree with the Company’s interpretation
of the written agreement under Special Protocol Assessment for the
SOL-1 trial; 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 the FDA’s view of the Company’s
proposed design for the SOL-R trial; 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, or whether preliminary or interim data from a
clinical trial will be predictive of final data from such trial;
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; the 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 may
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.
Investors & MediaOcular Therapeutix,
Inc.Bill SlatteryVice President, Investor
Relationsbslattery@ocutx.com
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