BEDFORD, Mass.--(BUSINESS WIRE)--Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, announced today enrollment of the first patients in a second Phase 3 clinical trial to evaluate the safety and efficacy of DEXTENZA™ (sustained release dexamethasone), 0.4mg Intracanalicular Depot for the treatment of allergic conjunctivitis. DEXTENZA is a product candidate administered by a physician as a bioresorbable intracanalicular depot and designed for drug release to the ocular surface for up 30 days, which would far surpass the duration of the current standard of care for ocular allergy treatment which is one day.
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 (Ora, Inc., Andover, MA) which accommodates for the longer therapeutic effect of a seasonal one-time administered drug product. The trial is designed to assess the effect of DEXTENZA compared with placebo on allergic reactions using four series of successive allergen challenges over a 30-day period. DEXTENZA or placebo will be administered 48 to 72 hours after final confirmatory exposure to the allergen. The primary endpoint to be evaluated is ocular itching at day 7 following insertion.
“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 Amar Sawhney, Ph.D., President, Chief Executive Officer and Chairman of Ocular Therapeutix, Inc. “For the first time, DEXTENZA offers the potential for full-season relief to the patient, as a product candidate designed to both treat ocular itching for 4 weeks and offer prophylaxis against allergic conjunctivitis.” Sawhney continued, “The start of another Phase 3 clinical trial for DEXTENZA demonstrates our commitment to applying our proprietary, hydrogel platform to additional indications where patients can benefit from sustained-release therapies. In addition to allergic conjunctivitis, the Company submitted a New Drug Application (NDA) to the FDA for a post-surgical ocular pain indication in October 2015, and an exploratory Phase 2 clinical trial in inflammatory dry eye is expected to read out with topline results before the end of the year.”
Ocular Therapeutix reported topline results of its first Phase 3 allergic conjunctivitis clinical trial in October 2015. If the Company meets the primary efficacy endpoint for ocular itching in the second Phase 3 trial and subject to the approval of the NDA submitted for DEXTENZA for the treatment of post-surgical ocular pain, the Company expects to submit an NDA supplement to the FDA for ocular itching associated with allergic conjunctivitis. Many ocular drugs used to treat allergic conjunctivitis have been approved by the FDA solely for ocular itching. Under a revised protocol, the Company’s only primary endpoint in the second Phase 3 trial is for ocular itching.
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.
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 candidate, DEXTENZA™, is
in Phase 3 clinical development for post-surgical ocular inflammation
and pain and allergic conjunctivitis, and in Phase 2 clinical
development for inflammatory dry eye disease. An NDA for the
post-operative ocular pain indication has been submitted to the FDA and
a third Phase 3 clinical trial is being conducted for post-operative
ocular inflammation and pain. The Company’s product candidate, OTX-TP
(sustained release travoprost)
intracanalicular depot, has completed a Phase 2b clinical trial for
glaucoma and ocular hypertension. Ocular Therapeutix 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 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 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.