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
Ocular Therapeutix, Inc.
Chief Financial Officer
Burns McClellan on behalf of Ocular Therapeutix
Kimberly Minarovich, 212-213-0006
Ocular Therapeutix, Inc.
Vice President of Sales and Marketing