Conference Call Today at 8:30 am Eastern
Time
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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20161114005450/en/
InvestorsOcular Therapeutix, Inc.Brad SmithChief
Financial Officerbsmith@ocutx.comorBurns McClellan on behalf of
Ocular TherapeutixSteve Klass,
212-213-0006sklass@burnsmc.comorMediaOcular Therapeutix,
Inc.Scott CorningVice President of Sales and
Marketingscorning@ocutx.com
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