Ocular Therapeutix, Inc., a leading developer of sustained ophthalmic therapies, announced enrollment of the first patient 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 chief executive officer 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.”
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 per cent to 40 per cent of the US 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.