Press Release
Ocular Therapeutix™ Begins Enrollment in its Second Phase 3 Clinical Trial for DEXTENZA™ for the Treatment of Allergic Conjunctivitis
This prospective, U.S.-based multicenter, 1:1 randomized, double-masked,
vehicle-controlled trial is enrolling patients who exhibit chronic signs
and symptoms of allergic conjunctivitis. This is the second Phase 3
trial that will evaluate DEXTENZA versus a placebo vehicle punctum plug
using Ophthalmic Research Associate’s modified Conjunctival Allergen
Challenge (Ora-CAC®) Model (
“We are pleased to advance the DEXTENZA platform in allergic
conjunctivitis, with the goal of providing patients with one-time,
seasonal therapy that is preservative-free,” said
About Allergic Conjunctivitis
Allergic conjunctivitis is an
inflammatory disease of the conjunctiva resulting primarily from a
reaction to allergy-causing substances such as pollen or pet dander. The
primary symptom of this inflammation is acute ocular itching and the
primary sign is conjunctival redness. Allergic conjunctivitis ranges in
clinical severity from relatively mild, common forms to more severe
forms that can cause impaired vision. According to a study on the
management of seasonal allergic conjunctivitis published in 2012 in the
peer-reviewed journal Acta Ophthalmologica, allergic
conjunctivitis affects 15% to 40% of the U.S. population. For patients
with chronic or more severe forms of allergic conjunctivitis,
antihistamines and mast cell stabilizers are often not sufficient to
treat their signs and symptoms. Many ocular allergy sufferers are not
responsive to the conventional dual-acting antihistamine/mast cell
stabilizers. These refractory patients are frequently treated with
topical corticosteroids administered by eye drops.
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
timing and conduct of a second Phase 3 clinical trial of DEXTENZA for
the treatment of allergic conjunctivitis, 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, and the Company’s exploratory Phase 2 clinical
trial of DEXTENZA for the treatment of inflammatory dry eye disease, 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