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 completion of enrollment in
the HELIOS clinical trial of OTX-TKI. Using Elutyx™ technology,
OTX-TKI is the Company’s axitinib intravitreal implant that is
being developed for the treatment of diabetic retinopathy, wet AMD
and other retinal diseases.
Diabetic retinopathy is a leading cause of vision loss in
working-age adults, affecting approximately 140 million individuals
around the world, including 8.4 million people in the United States
alone. Diabetic retinopathy can lead to vision loss and even
blindness due to high levels of blood sugar in the eyes that damage
the blood vessels in the retina, the light-sensitive tissue at the
back of the eye.
“Millions of people suffer from diabetic retinopathy. Today, the
current standard of care in non-proliferative stages is primarily
‘watchful waiting’, as frequent anti-VEGF injections and office
visits pose a significant treatment burden primarily for the
working-age population. Many patients frequently progress to more
severe vision-destroying disease before they seek treatment, making
diabetic retinopathy one of the leading causes of blindness among
working-age adults in the U.S.,” said Rabia Gurses Ozden, MD, Chief
Medical Officer of Ocular Therapeutix. “We believe the same
attributes that make OTX-TKI a compelling product candidate for the
treatment of wet AMD – the ease of use of an office-based injection
and the potential for long-term durability that reduces the
treatment burden and need for frequent, invasive injections – could
establish OTX-TKI as the standard of care in the treatment of
diabetic retinopathy.”
The HELIOS Phase 1 trial is a multi-center, prospective, masked,
2:1 randomized, controlled U.S.-based trial in 21 subjects
evaluating 600 µg OTX-TKI dosed in a single implant containing
axitinib compared to a sham injection procedure. Interim 6-month
data from the trial are expected in the first quarter of 2024. The
Company has been in discussions with the FDA for the clinical
development of OTX-TKI for the treatment of diabetic retinopathy
and has a potential pivotal design that is consistent with guidance
from the FDA. Subject to favorable interim data from the ongoing
clinical trial and obtaining the necessary financing to fund the
trial, the Company plans to be prepared to initiate a Phase 3
pivotal trial for diabetic retinopathy as early as Q1 2024. This is
in addition to the Company’s plan to be prepared for initiation of
a pivotal program in wet AMD as early as Q3 of 2023, subject to
obtaining the necessary financing.
About OTX-TKI
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 age-related macular degeneration (wet
AMD), diabetic retinopathy and other retinal diseases.
About Diabetic Retinopathy
Diabetic retinopathy is a chronic, progressive disease driven by
elevated levels of blood glucose and depleted levels of oxygen
causing damage to blood vessels in the retina. Diabetic retinopathy
is among the most common microvascular complications of diabetes
and is a leading cause of blindness globally. Diabetic retinopathy
can take time to develop, and may progress from early, mild,
non-proliferative diabetic retinopathy (NPDR) to moderate and then
severe NPDR and eventually to proliferative diabetic retinopathy
(PDR). As patients progress from mild to severe NPDR, the risk of
developing proliferative disease increases. PDR is the most serious
stage of the disease and develops when areas of the retina that are
starved for nourishment and oxygen, triggering the proliferation of
new blood vessels via secretions of vascular endothelial growth
factor (VEGF). Diabetic macular edema (DME), an accumulation of
fluid in the macula, can occur at any stage of diabetic
retinopathy. The current standard of care for NPDR is watchful
waiting, although damage to blood vessels in the retina is ongoing
in the background, with anti-VEGFs used more commonly when the
disease has progressed to the proliferative stage. Regular eye
examinations are crucial for early detection and prevention of
diabetic retinopathy.
There were an estimated 8.4 million cases of diabetic
retinopathy in the United States in 2022 according to Market Scope,
of which 3.3 million cases were moderate to severe
non-proliferative, growing at an approximately 2% compound annual
growth rate through 2027. Overall, there are an estimated 141.2
million cases of diabetic retinopathy globally, growing at a
compound annual growth rate of 3%. Prevalence of diabetic
retinopathy is expected to increase due to population growth and
increasing incidence of diabetes throughout much of the world.
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 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-DED (dexamethasone intracanalicular
insert) for the short-term treatment of the signs and symptoms of
dry eye disease; and OTX-CSI (cyclosporine intracanalicular insert)
for the chronic treatment of dry eye disease, both of which have
completed Phase 2 clinical trials.
Forward Looking Statements
Any statements in this press release about future expectations,
plans, and prospects for the Company, including the
commercialization of DEXTENZA® or any of the Company’s products or
product candidates; the development and regulatory status of the
Company’s product candidates, such as the Company’s development of,
timing of, and prospects for approvability of OTX-TKI for the
treatment of retinal diseases including wet AMD and diabetic
retinopathy including the timing of planned pivotal clinical
trials, OTX-TIC for the treatment of primary open-angle glaucoma or
ocular hypertension, OTX-DED for the short-term treatment of the
signs and symptoms of dry eye disease, and OTX-CSI for the chronic
treatment of dry eye disease; the Company’s plans to advance the
development of its product candidates or preclinical programs; the
Company’s ability to fund the planned and future development of its
product candidates, whether through strategic alliances or other
fundraising; the potential utility of any of the Company’s product
candidates; the size of potential markets for the Company’s product
candidates; 2023 financial guidance, including estimated net
product revenue; the 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, timing, conduct and outcomes of
clinical trials, whether clinical trial data will be indicative of
the results of subsequent clinical trials in the same or other
indications or that interim data will be indicative of the full
data from a clinical trial, uncertainties as to the timing and
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, 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.
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
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