Ocular Therapeutix™ Begins Enrollment in First Phase 3 Clinical Trial with OTX-TP

Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, today announced the enrollment of the first patient in the first of two planned Phase 3 clinical trials with OTX-TP (sustained release travoprost) for the treatment of glaucoma and ocular hypertension. OTX-TP is a preservative-free drug product candidate that resides within the canaliculus and is designed to deliver the prostaglandin analog travoprost to the ocular surface for up to 90 days.
The U.S.-based, prospective, multicenter, randomized, parallel-arm,
placebo-controlled study is expected to enroll approximately 550
patients with open angle glaucoma or ocular hypertension at 50 clinical
sites. Importantly, the Phase 3 study design will not include a timolol
comparator or validation arm, and will not have active or placebo eye
drops administered in either arm. The comparator arm will utilize a
non-drug eluting hydrogel-based intracanalicular insert. The primary
efficacy endpoint will be statistically superior reduction of
intraocular pressure (IOP) from baseline with OTX-TP compared to placebo
at 2, 6 and 12 weeks following insertion.
“This is the first Phase 3 clinical trial to be conducted with a
non-invasive, sustained release drug candidate for the treatment of
glaucoma and represents an important advancement in the field of
ophthalmology,” stated Robert Noecker, MD, MBA, Ophthalmic Consultants
of Connecticut, and Assistant Clinical Professor, Yale University School
of Medicine. “While currently approved topical therapies are effective
when dosed ideally, studies show that more than 50% of patients are not
compliant with their therapy within the first six months of treatment.
This is a very significant issue in the treatment of glaucoma. Sustained
release drug candidates such as OTX-TP address this issue directly, by
allowing patients who are either unable to acquire, do not remember to,
or who incorrectly administer eye drop regimens, to have a convenient
way to manage their disease. The preservative-free and sustained nature
of OTX-TP has the potential to improve the side effect profile as well.”
“This is the first of two planned Phase 3 clinical trials that will both
include an OTX-TP treatment arm and a placebo-controlled comparator arm
using a non-drug eluting hydrogel-based intracanalicular insert,” said
Amar Sawhney, Ph.D., President, Chief Executive Officer and Chairman.
“This reflects the most appropriate real-world study design, as
learnings from previous studies have indicated that the presence of the
inserts in the control arm may have inadvertently enhanced the effect of
timolol. We expect topline results from the first Phase 3 clinical trial
to be available in the first half of 2018, and plan to commence the
second phase 3 clinical trial in the first half of 2017. With over $2.7
billion in sales of eye drop therapies for the treatment of glaucoma in
the U.S. last year, glaucoma is a large and important market opportunity
for Ocular Therapeutix.”
Dr. Sawhney continued, “We are also pleased with the results of the
refined OTX-TP product configuration we will be using in these studies.
Our most recent results from ongoing non-significant risk (NSR)
investigational device exemption (IDE) human clinical studies using the
non-drug eluting version of the insert show significant improvements in
retention rates at three months compared to previous studies.”
About Glaucoma and Ocular Hypertension
Glaucoma is a chronic, sight-threatening disease in which abnormally
high intraocular pressure may cause damage to the optic nerve, resulting
in irreversible vision loss. Glaucoma is the second leading cause of
blindness in the world. Ocular hypertension is characterized by higher
levels of intraocular pressure without detectable optic nerve damage.
Patients with ocular hypertension are at high risk of developing
glaucoma. In the U.S. alone, 2.7 million people suffer from glaucoma.
According to IMS Health data, there were 34 million prescriptions and
sales of over $2.7 billion of drugs administered by eye drops for the
treatment of glaucoma in the U.S. in 2015.
Compliance is seen as the biggest problem with existing therapies for
glaucoma, and more than 50% of patients on topical prostaglandin analogs
are not compliant with their therapy within the first six months of
treatment.
About OTX-TP (Sustained Release Travoprost)
OTX-TP (sustained release travoprost) is a preservative-free drug
product candidate that resides within the canaliculus and is designed to
deliver the prostaglandin analog travoprost to the ocular surface for up
to 90 days. OTX-TP is designed to deliver a continuous steady release
throughout the treatment period. A fluorescent visualization aid is
formulated within the product to enable both the physician and the
patient to monitor drug presence throughout the course of therapy. If
approved, OTX-TP may become the first non-invasive, sustained release
therapy for the treatment of glaucoma.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. (NASDAQ: OCUL) is a biopharmaceutical company
focused on the development and commercialization of innovative therapies
for diseases and conditions of the eye using its proprietary hydrogel
platform technology. Ocular Therapeutix has submitted an NDA for
post-surgical pain for its lead product candidate, DEXTENZA™
(dexamethasone insert), which is in Phase 3 clinical development for
post-surgical ocular inflammation and pain and allergic conjunctivitis,
and in Phase 2 clinical development for dry eye disease. OTX-TP
(sustained release travoprost) is in Phase 3 clinical development for
glaucoma and ocular hypertension. Ocular Therapeutix is also evaluating
sustained-release injectable drug depots for back-of-the-eye diseases.
Ocular Therapeutix’s first product, ReSure® Sealant, is FDA-approved to
seal corneal incisions following cataract surgery. For additional
information about the Company, please visit www.ocutx.com.
Forward Looking Statements
Any statements in this press release about future expectations, plans
and prospects for the Company, including statements about the
development and regulatory status of the Company’s product candidates,
such as the Company’s expectations and plans regarding regulatory
submissions for and the timing and conduct of clinical trials of
DEXTENZA™ for post-surgical ocular inflammation and pain, including our
expectations regarding the NDA filed with the FDA, DEXTENZA for the
treatment of allergic conjunctivitis, DEXTENZA for dry eye disease and
OTX-TP for the treatment of glaucoma and ocular hypertension, the
ongoing development of the Company’s sustained release hydrogel depot
technology and the advancement of the Company’s other product
candidates, the potential utility of any of the Company’s product
candidates, potential commercialization of the Company’s product
candidates, the sufficiency of the Company’s cash resources and other
statements containing the words “anticipate,” “believe,” “estimate,”
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“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 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, those related to the timing and costs involved in
commercializing ReSure® Sealant or any product candidate that receives
regulatory approval, the initiation and conduct of clinical trials,
availability of data from clinical trials and expectations for
regulatory submissions and approvals, the Company’s scientific approach
and general development progress, the availability or commercial
potential of the Company’s product candidates, the sufficiency of cash
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