Ocular Therapeutix Announces First Patient Dosed in Phase 3 Clinical Trial of Dextenza for the Treatment of Allergic Conjunctivitis
Ocular Therapeutix announced that it has dosed the first patients in its phase 3 clinical trial of Dextenza for the treatment of symptoms of allergic conjunctivitis. Allergic conjunctivitis refers to inflammation of the conjunctiva of the eye caused by an allergic reaction–generally from airborne allergens–that affects approximately 70 million people in the United States and results in itching and burning of the eyes.
“We are pleased to be advancing Dextenza for allergic conjunctivitis,” Antony Mattessich, President and Chief Executive Officer, said in a company news release. “We believe Dextenza has the potential to replace the current standard of care eye drops with a one time, long-acting, seasonal therapy for the treatment of allergic conjunctivitis. With the start of this phase 3 trial, following the recent approval of Dextenza in the U.S. by the Food and Drug Administration (FDA) for the treatment of ocular inflammation and pain following ocular surgery, we are clearly focused on demonstrating Dextenza’s potential as a platform product for Ocular Therapeutix both in the surgical and outpatient settings.”
The phase 3 clinical trial is a U.S.-based, multicenter, 1:1 randomized, double-masked, placebo-controlled trial that intends to enroll approximately 80 subjects. The study’s primary objective is to evaluate the safety and efficacy of Dextenza (dexamethasone ophthalmic insert) 0.4 mg versus a placebo vehicle punctum plug using the Ophthalmic Research Associates’ modified Conjunctival Allergen Challenge (Ora-Cac) Model for the treatment of ocular itching associated with allergic conjunctivitis. The trial is designed to assess the effect of Dextenza compared with a placebo on allergic reactions using a series of successive allergen challenges over a 30-day period. The primary efficacy endpoint being evaluated in the study is ocular itching following insertion of Dextenza at multiple time points during the 30 day period. Dextenza is administered by a physician as a bioresorbable intracanalicular insert and designed for drug release to the ocular surface for up to 30 days.
This trial represents the third phase 3 clinical trial in allergic conjunctivitis conducted by Ocular Therapeutix and, if successful, the company plans to submit a supplemental new drug application (sNDA) to the FDA for ocular itching associated with allergic conjunctivitis. Topline data from this trial are anticipated in the first half of 2020.
About Dextenza (dexamethasone ophthalmic insert) 0.4 mg
Dextenza is an FDA-approved corticosteroid indicated for the treatment of ocular inflammation and pain following ophthalmic surgery. Dextenza is inserted into the canaliculus by the physician following ophthalmic surgery. A single Dextenza releases a 0.4 mg dose of dexamethasone for up to 30 days following insertion. Dextenza is preservative free, resorbable and does not require removal.
Dextenza is contraindicated in patients with active corneal, conjunctival or canalicular infections. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be monitored during the course of the treatment. Corticosteroids may suppress the host response to, and increase the hazard for and severity of, secondary bacterial, viral, or fungal infections. The use of steroids after cataract surgery may delay wound healing and increase the incidence of bleb formation.
The most commonly reported ocular adverse reactions that occurred in patients treated with Dextenza were anterior chamber inflammation including iritis and iridocyclitis (10%) and elevations in intraocular pressure (6%). The most common non-ocular adverse reaction was headache (1%).
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