Ocular Therapeutix™ Announces Successful Topline Results from Phase 3 Clinical Trial of DEXTENZA™

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 positive topline
results from its phase 3 clinical trial of DEXTENZA™ (dexamethasone insert) 0.4 mg, for the treatment of post-surgical ocular inflammation and pain. DEXTENZA is a product candidate administered by a physician as a bioresorbable intracanalicular insert and designed for drug release to the ocular surface for up to 30 days.
The trial successfully met its two primary efficacy endpoints for
inflammation and pain, achieving statistically significant differences
between the treatment group and the placebo group for the absence of
inflammatory cells on day 14 and the absence of pain on day 8,
respectively. 52.3%% of patients treated with DEXTENZA showed an absence
of inflammatory cells in the anterior chamber of the study eye on day
14, compared to 31.1% of those receiving the placebo vehicle control
punctum plug (p< 0.0001). 79.6% of patients treated with DEXTENZA
reported absence of pain in the study eye on day 8, compared to 61.3% of
those receiving the placebo vehicle control punctum plug (p< 0.0001).
For clarification of the endpoints, the day of surgery and insertion of
DEXTENZA or the placebo is considered to be day 1.
“The successful results of this trial represent an important milestone
for the Company, and we believe these results not only further validate
the ability of DEXTENZA to provide a full post-operative course of
therapy with a one-time administration, but also validate the broader
utility of our multi-faceted hydrogel drug delivery technology
platform,” said Amar Sawhney, Ph.D., President, Chief Executive Officer
and Chairman. “We are preparing for the resubmission to our NDA for
DEXTENZA for the post-surgical ocular pain indication by the end of the
year, and subject to potential approval, we plan to submit an NDA
supplement for DEXTENZA to include a post-surgical ocular inflammation
indication. This is an exciting time for Ocular Therapeutix, as we
advance our lead drug delivery product candidate toward potential
commercialization.”
In this Phase 3 clinical trial with DEXTENZA for the treatment of
post-surgical ocular inflammation and pain, as well as other DEXTENZA
clinical trials completed to date regardless of indication, DEXTENZA has
exhibited a strong safety profile and has been generally well-tolerated.
There were no treatment-related serious adverse events observed in this
Phase 3 clinical trial. DEXTENZA inserts were visible in almost all
subjects through Day 30, with 99% present at the primary efficacy
endpoint visits.
Secondary efficacy endpoints included differences between the DEXTENZA
treatment group and the placebo group for the absence of anterior
chamber (AC) cells at day 2, 4, 14 and 30 and for the absence of pain at
day 2, 4, 14 and 30. All eight of these secondary endpoints were met at
a level of statistical significance with the exception of the endpoint
for the absence of AC cells at day 2. Additional secondary endpoints
including flare, as well as an assessment of all safety data, are being
evaluated.
“In parallel with steadily rising ophthalmic surgical volumes among the
aging U.S. population is the requirement for safe and effective
outcomes, driven not only by operative technique but also by appropriate
post-operative drug delivery,” said Dr. Terry Kim, Chief of the Cornea
and External Disease Service at the Duke University Eye Center and
Professor of Ophthalmology, Duke University School of Medicine.
“DEXTENZA’s demonstrated ability to provide a full post-operative course
of therapy with a single placement is attractive for both patients and
physicians. A large majority of my patients show poor compliance and
improper technique when using current standard of care steroid eye
drops, which can lead to prolonged recovery and suboptimal outcomes as
well as unnecessary phone calls and office visits to the physician.
DEXTENZA has the potential to improve both compliance and outcomes,
enabling the transfer of control back to the physician for the entire
course of therapy.”
Phase 3 Study Design
This prospective, multicenter, 1:1 randomized, parallel-arm,
double-masked, vehicle-controlled study was designed to evaluate the
safety and efficacy of DEXTENZA for the treatment of ocular inflammation
and pain following ophthalmic surgery. The study enrolled 438 patients
who were undergoing clear corneal cataract surgery at 21 sites
throughout the United States. Immediately following surgery, patients
were randomized to either DEXTENZA or a placebo vehicle. Primary
efficacy endpoints evaluated the differences between the DEXTENZA
treatment group and the placebo group for the absence of anterior
chamber cells at day 14 and absence of pain at day 8.
This was the third Phase 3 clinical trial that the Company has conducted
with DEXTENZA for the treatment of ocular inflammation and pain
following ophthalmic surgery. Based on the results from the first two
Phase 3 clinical trials, Ocular Therapeutix submitted a New Drug
Application (NDA) to the FDA for DEXTENZA for the treatment of ocular
pain occurring after ophthalmic surgery. The purpose of conducting this
third Phase 3 clinical trial is part of the Company’s label expansion
strategy for DEXTENZA. Accordingly, subject to the approval of the NDA
for post-surgical ocular pain by the FDA, Ocular Therapeutix intends to
submit an NDA supplement for DEXTENZA to broaden its label to include a
post-surgical inflammation indication.
About Ocular Inflammation and Pain Following Ophthalmic Surgery
Ocular pain and inflammation are common side effects following
ophthalmic surgery. Physicians prescribe topical corticosteroids as part
of the standard of post-operative care. If left untreated, inflammation
of the eye may result in further ocular complications, including
scarring and vision loss. According to US Census data, by the year 2020,
it is estimated that the number of Americans diagnosed with cataracts is
expected to rise to approximately 30 million, representing a 31.9%
increase over current prevalence estimates. Approximately 3.8 million
cataract cases were performed in the United States in 2015.
Conference Call & Webcast Information
Members of the Ocular Therapeutix management team will host a live
conference call and webcast today at 8:30 am Eastern Time to discuss the
topline results of the recently completed Phase 3 clinical trial of
DEXTENZA for the treatment of ocular inflammation and pain following
ophthalmic surgery.
The live webcast can be accessed by visiting the investor section of the
Company’s website at investors.ocutx.com. Please connect at least 15
minutes prior to the live webcast to ensure adequate time for any
software download that may be needed to access the webcast.
Alternatively, please call 844-464-3934 (U.S.) or 765-507-2620
(International) to listen to the conference call. The conference ID
number for the live call will be 19890131. An archive of the webcast
will be available until November 28, 2016 on the Company’s website.
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.
OTX-TP (travoprost insert) is in Phase 3 clinical development for
glaucoma and ocular hypertension. Ocular Therapeutix is also evaluating
injectable drug delivery 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 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 the treatment of
post-surgical ocular inflammation and pain, including our expectations
regarding the NDA filed with the FDA and the resubmission of the NDA,
DEXTENZA for the treatment of allergic conjunctivitis, DEXTENZA for the
treatment of inflammatory 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, the potential
utility of any of the Company’s product candidates, potential
commercialization of the Company’s product candidates, the potential
benefits and future operation of the collaboration with Regeneron,
including any potential future payments thereunder, 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 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
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.