First Phase 3 trial expected to commence in the third quarter of 2016
Trial design to evaluate OTX-TP using placebo as comparator; no
timolol validation arm required
BEDFORD, Mass.--(BUSINESS WIRE)--Apr. 27, 2016--
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 that it has
completed its End-of-Phase 2 review with the U.S. Food and Drug
Administration (FDA) for its OTX-TP (sustained release travoprost)
product candidate for the treatment of glaucoma and ocular hypertension.
Based on this review, the company intends to initiate the first of two
Phase 3 clinical trials during the third quarter of 2016. The FDA has
stated that it agrees with the overall Phase 3 clinical development
program proposed by Ocular Therapeutix in its briefing package submitted
to the FDA, which includes the following:
Two Phase 3 clinical trials that will include an OTX-TP treatment arm
and a placebo-controlled comparator arm that would use a non-drug
eluting hydrogel-based intracanalicular depot.
The Phase 3 study design will not include a timolol comparator or
The study design will not have eye drops, placebo or active,
administered in either arm.
A primary efficacy endpoint of statistically superior and clinically
meaningful reduction of intraocular pressure (IOP) from baseline with
OTX-TP compared to placebo at 60 and 90 days. The FDA has also
indicated that they will take into consideration the risk-reward
profile of OTX-TP relative to currently available therapies in their
evaluation of the Phase 3 clinical trial results.
“We are pleased with the End-of-Phase 2 feedback from FDA concerning our
Phase 3 clinical development plan, which proposes a trial design that
compares OTX-TP with a placebo arm. We believe this reflects a
real-world appropriate clinical study design for this drug product
candidate,” said Amar Sawhney, Ph.D., President, Chief Executive Officer
and Chairman. “OTX-TP has shown a clinically meaningful IOP-lowering
effect in clinical trials to date, and may offer an important
advancement in the treatment of glaucoma. Importantly, we believe OTX-TP
may be able to address the major issue of low patient compliance rates
associated with currently approved topical therapies and their chronic,
burdensome dosing schedules while potentially improving the safety
profile due to the absence of preservatives.”
About Glaucoma and Ocular Hypertension
Glaucoma is a
chronic, sight-threatening diseases in which elevated levels of
intraocular pressure are associated with damage to the optic nerve,
which may result in irreversible vision loss. Glaucoma is the second
leading cause of blindness in the world. Ocular hypertension is
characterized by elevated levels of intraocular pressure without any
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
About OTX-TP (Sustained Release Travoprost)
(sustained release travoprost) is a preservative-free drug product
candidate that resides within the canaliculus and delivers the
prostaglandin analog travoprost to the ocular surface for up to 90 days.
The drug depot 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.
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's lead product candidate, DEXTENZA™
(sustained release dexamethasone) Intracanalicular Depot, 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. A New Drug Application (NDA) for the post-operative ocular pain
indication has been filed with FDA and has a Prescription Drug User Fee
Act (PDUFA) date of July 24, 2016. A third Phase 3 clinical trial is
being conducted for post-operative ocular inflammation and pain. For
glaucoma and ocular hypertension, a Phase 2b clinical trial has been
completed with OTX-TP (sustained release travoprost) and the first of
two planned OTX-TP Phase 3 clinical trials is expected to be initiated
in the third quarter of 2016. Ocular Therapeutix is also evaluating
sustained-release injectable anti-VEGF 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.
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 ongoing development of OTX-TP
for glaucoma and ocular hypertension and the timing, design and conduct
of the planned Phase 3 clinical trials of OTX-TP, the availability of
data from clinical trials, the Company’s plans for regulatory
submissions, the potential utility of any of the Company’s product
candidates, the ongoing development of the Company’s sustained release
hydrogel depot technology and the advancement of the Company’s other
product candidates, 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
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 other product candidates that may
receive 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
resources and need for additional financing or other actions 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 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. 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 release.
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Source: Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc.
McClellan on behalf of Ocular Therapeutix
Steve Klass, 212-213-0006
Vice President of Sales and