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 Phase 3 clinical trial to evaluate the safety and efficacy of DEXTENZA™ (sustained release dexamethasone, 0.4mg) for the treatment of allergic conjunctivitis. DEXTENZA is administered by a physician as a bioresorbable intracanalicular depot for drug release to the ocular surface for up 30 days.
This prospective, US based multicenter, 1:1 randomized, parallel-arm, double-masked, vehicle-controlled study is enrolling subjects who exhibit chronic signs and symptoms of allergic conjunctivitis. This is the first of two Phase 3 studies and will evaluate DEXTENZA versus a placebo vehicle punctum plug using Ora’s modified Conjunctival Allergen Challenge (Ora-CAC®) Model (Ora, Inc., Andover, MA) which accommodates for the longer therapeutic effect of a one-time administered sustained release drug product. The study is designed to assess the effect of DEXTENZA compared with placebo on allergic reactions using three 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, and the primary endpoints to be evaluated are ocular itching and conjunctival redness at day 7 following insertion. The secondary efficacy measures for both itching and redness are measured at day 14 following insertion and on days 27-30 post-insertion.
Carolyn Repke, MD, Principal Investigator at Philadelphia Eye Associates, and first enroller in the study commented, "When my patients are experiencing more frequent or more severe symptoms, I often consider a steroid since they block most mediators of inflammation and work effectively in the acute phase of allergic conjunctivitis. With DEXTENZA, I will be able to offer my patients enduring relief against these symptoms with one-time administration, and a release profile that avoids the peaks and valleys associated with topical dosing."
“This Phase 3 allergic conjunctivitis study marks our commitment to a clinical indication expansion strategy for DEXTENZA as we pursue both post-surgical pain and inflammation, and now allergic conjunctivitis,” stated Amar Sawhney, Ph.D., President and CEO of Ocular Therapeutix, Inc. “Severe allergy patients are often prescribed topical steroids for their condition, and we believe DEXTENZA may serve as an attractive alternative in treating allergic conjunctivitis due to its constant yet low-dose elution of therapy over an extended period.”
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 sign of this inflammation is conjunctival redness and the
primary symptom is acute ocular itching. 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. The first line
of defense against allergic conjunctivitis is avoidance of the allergen.
If this is not successful, physicians typically prescribe a mast cell
stabilizer or antihistamine. These treatments act to reduce the signs
and symptoms of the early phase allergic reaction. For the subset of
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. 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 candidates are in Phase 3
clinical development for post-surgical ocular inflammation and pain and
allergic conjunctivitis, and Phase 2 clinical development for glaucoma
and inflammatory dry eye disease. The Company 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 of the Company’s product
candidates, such as the Company’s plans for regulatory submissions and
the design, initiation and conduct of a Phase 3 clinical trial of OTX-DP
for allergic conjunctivitis, the ongoing development of the Company’s
sustained release hydrogel depot technology, , the advancement of the
Company's other 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 and DEXTENZA,
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 Report on
Form 10-Q for the three months ended March 31, 2015 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.