Third Phase 3 Clinical Trial for Post-Surgical Ocular Inflammation
and Pain Expected to Be Initiated in October 2015
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
submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for DEXTENZA® (sustained
release dexamethasone) 0.4mg Intracanalicular Depot, for the treatment
of ocular pain following ophthalmic surgery. The data included in the
NDA submission are from a Phase 2 clinical trial and two Phase 3
clinical trials conducted with this product candidate.
“This represents Ocular Therapeutix’s first NDA filing with the FDA and
is an important development milestone as we advance our broad-based
programs for the treatment of ocular diseases and conditions through
clinical development and potential commercialization pending FDA
approval. We look forward to offering patients this exciting alternative
to steroid eye drop therapy,” said Amar Sawhney, Ph.D., President, Chief
Executive Officer and Chairman. “DEXTENZA offers patients a full
post-operative course of therapy with one-time administration as
compared to the current standard of care requiring multiple eye drops
daily. DEXTENZA also avoids the peaks and valleys of dosage associated
with eye drops and provides the potential for an improved safety profile
including minimal intraocular pressure spikes.”
Based on the results of the Company’s two completed Phase 3 clinical
trials and following a Pre-NDA Clinical meeting with the FDA in April
2015, the Company formulated its plans for submitting an NDA for
DEXTENZA for the treatment of post-surgical ocular pain and for
conducting a third Phase 3 clinical trial of DEXTENZA for the treatment
of post-surgical ocular inflammation and pain. The Company intends to
submit a supplement to the NDA for the treatment of post-surgical
inflammation as part of its label expansion strategy for DEXTENZA if it
obtains favorable results from the third Phase 3 clinical trial, which
is expected to commence later this year, and subject to the approval of
the NDA for post-surgical ocular pain by the FDA.
About DEXTENZA
DEXTENZA (sustained release dexamethasone) 0.4 mg Intracanalicular Depot
is a product candidate placed through the punctum, a natural opening in
the eyelid, into the canaliculus and is designed to deliver
dexamethasone to the ocular surface for four weeks. Following treatment,
DEXTENZA resorbs and exits the nasolacrimal system without need for
removal. Earlier this year, Ocular Therapeutix announced results from
its two Phase 3 clinical trials of DEXTENZA for the treatment of
post-operative ocular inflammation and pain. To capitalize on the
broader opportunity for the sustained delivery of corticosteroids to the
front of the eye, the Company is pursuing additional indications for
DEXTENZA. The Company recently completed enrollment in a Phase 3
clinical trial of DEXTENZA for the treatment of allergic conjunctivitis
and expects to report topline efficacy data from this trial in the
fourth quarter of 2015. The Company has also completed patient
enrollment in an exploratory Phase 2 clinical trial of DEXTENZA for the
treatment of inflammatory dry eye and expects to report topline efficacy
data from this trial in the fourth quarter of 2015.
Two prospective, multicenter, randomized, parallel-arm, double-masked,
vehicle-controlled Phase 3 clinical trials were completed with a total
of 487 patients undergoing unilateral clear corneal cataract surgery in
the first half of 2015. Patients were randomized 2:1 to receive either
DEXTENZA or a placebo vehicle control punctum plug without active drug.
Both primary efficacy endpoints, differences in the proportion of
patients in the DEXTENZA treatment group compared with the placebo group
with absence of cells in the anterior chamber of the study eye, as
measured using slit lamp examination, at day 14 and absence of pain, as
graded by a patient-reported score of zero on a scale from zero to ten,
at day 8, were recorded at each study visit. Secondary efficacy
endpoints were absence of flare in the anterior chamber of the study eye
at each evaluation date and absence of inflammatory cells in the
anterior chamber of the study eye and absence of pain in the study eye
at each evaluation date other than the day used for the primary efficacy
measure.
About Post-Surgical Ocular Inflammation and Pain
Ocular pain and inflammation are common side effects following
ophthalmic surgery. Physicians prescribe anti-inflammatory drugs, such
as corticosteroids, as the standard of care. If left untreated,
inflammation of the eye may result in further ocular complications,
including scarring and vision loss. Approximately 5.3 million ocular
surgeries were performed in the United States in 2014.
About Ocular Therapeutix
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 candidates are in
Phase 3 clinical development for post-surgical ocular inflammation and
pain and allergic conjunctivitis, and Phase 2 clinical development for
glaucoma and inflammatory dry eye disease. The Company 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 of the Company’s product candidates, such as the Company’s
plans for regulatory submissions and the design, initiation and conduct
of a third clinical trial of DEXTENZA® for
post-surgical inflammation and pain, the ongoing development of the
Company’s sustained release hydrogel depot technology, the timing and
conduct of the Company’s Phase 2b clinical trial of OTX-TP for the
treatment of glaucoma and ocular hypertension, the Company’s Phase 3
clinical trials of DEXTENZA for allergic conjunctivitis and the
Company’s Phase 2 clinical trial of OTX-DP for the treatment of
inflammatory dry eye disease, the advancement of the Company's other
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 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, 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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