Press Release
Ocular Therapeutix™ Announces Encouraging Top-Line Results from Exploratory Phase 2 Trial for DEXTENZA™ in Patients with Inflammatory Dry Eye Disease
- DEXTENZA showed benefit in efficacy measure of corneal staining signs of inflammatory dry eye disease for total corneal staining change from baseline at day 30
- Supportive measures of conjunctival staining also showed clinically meaningful benefit
- Improvement of frequency and severity of symptoms of eye dryness, itchiness, and scratchiness also seen
The Phase 2 exploratory clinical trial was a prospective, multicenter,
randomized, parallel-arm, bilateral, double-masked, vehicle controlled
study to explore the safety and efficacy of DEXTENZA for the treatment
of subjects exhibiting signs and symptoms of moderate to severe dry eye
disease. The trial was conducted at two sites in
In this trial, patients were selected for a minimum threshold of signs
of corneal staining and were randomized to either treatment with
DEXTENZA or a placebo vehicle depot. Patients were stratified into
groups based on the level of
While patients in this trial did not have a specific inclusion threshold for symptoms of dry eye disease at the time of randomization, changes from baseline to Day 15 and Day 30 in frequency and severity of symptoms of eye dryness, itchiness, and scratchiness, as measured by the standard patient evaluation of eye dryness (SPEED) questionnaires were noted to favor the patient groups treated with DEXTENZA. There were certain other measures included in the trial where DEXTENZA did not show a benefit over the placebo group. The trial was designed to include many different measures and identify those measures where DEXTENZA showed a benefit compared with the placebo vehicle depot group to inform the design of future clinical trials. The trial achieved this objective.
“We are encouraged that DEXTENZA showed improvements in the important
and highly relevant efficacy measures of total and inferior corneal
staining in this exploratory study. It is apparent that DEXTENZA
exhibited a global effect across all regions on the cornea, particularly
the inferior region, which is generally considered to be the most
susceptible region of the cornea for the onset of dry eye disease,” said
"Subject to further clinical testing, DEXTENZA may be able to satisfy an
unmet need for our patients with dry eye disease with its dual mechanism
of action, preservative free formulation, and rapid onset efficacy with
minimal compliance or safety concerns," stated
This initial exploratory dry eye study has helped to identify and concentrate the optimal patient population for sign responders. Additional work will be done to identify and concentrate the proper study population for symptoms responders.
While safety data continues to be analyzed, overall DEXTENZA had a good safety profile and was well tolerated. There were no intraocular pressure spikes noted in the trial. The retention rate of the drug depots was 96% through day 30 of the treatment phase of the trial.
About DEXTENZA
DEXTENZA is a product candidate administered by a physician as a
bioresorbable intracanalicular depot and designed for extended drug
release to the ocular surface for 30 days.
About Dry Eye Disease
Dry eye disease affects the ocular surface and is characterized by
dryness, inflammation, pain, discomfort, and irritation. Dry eye is a
complex, multifactorial disease which can present differently in
patients, and becomes more common with age. Due to the prevalence of the
disease, over
About Ocular Therapeutix, Inc.
Forward Looking Statements
Any statements in this press release about future expectations, plans
and prospects for the Company, including statements about the
development or potential commercialization of the Company’s product
candidates, such as the Company’s clinical development of DEXTENZA for
the treatment of inflammatory dry eye disease, the Company’s plans and
expectations regarding regulatory submissions and the design and conduct
of a third Phase 3 clinical trial of DEXTENZA™ for post-surgical
inflammation and pain, the timing and conduct of a second Phase 3
clinical trial of DEXTENZA for the treatment of allergic conjunctivitis,
the timing and conduct of the Company’s additional development work and
clinical trials of OTX-TP for the treatment of glaucoma and ocular
hypertension and the ongoing development of the Company’s sustained
release hydrogel depot technology, the advancement of the Company's
other product candidates, the potential utility of any of the Company’s
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
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Source:
Investors
Ocular Therapeutix, Inc.
Brad Smith
Chief
Financial Officer
bsmith@ocutx.com
or
Burns
McClellan on behalf of Ocular Therapeutix
Kimberly Minarovich,
212-213-0006
kminarovich@burnsmc.com
or
Media
Ocular
Therapeutix, Inc.
Scott Corning
Vice President of Sales and
Marketing
scorning@ocutx.com