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To evaluate the safety and efficacy of DEXTENZA (DEX), a resorbable, sustained-release intracanalicular insert delivering a 0.4 mg hands-free, tapered dose of dexamethasone over 30 days for the treatment of allergic conjunctivitis using a modified Conjunctival Allergen Challenge (CAC) Model.
A multi-center, randomized, prospective, double-masked, vehicle-controlled Phase 3 study was conducted using multiple CAC challenges. DEX or placebo vehicle (PV) was inserted bilaterally on Day 1 in subjects (N=96) after confirmation of positive allergic reaction. Ocular itching was evaluated at 3, 5, and 7 mins post-CAC at Day 8 (8 hours post Visit 6a, 7 days post-insertion) as the primary study endpoint. Other secondary efficacy measures include ocular itching (other time points), other ocular and non-ocular symptoms post-CAC at Days 7, 8, 14, 15. Safety assessments included adverse event (AE) collection, visual acuity, slit lamp, punctum exam, intraocular pressure and fundoscopy.
For the primary endpoint, DEX was statistically significantly superior for lowering mean ocular itch scores compared with PV at all time points (P<0.0001). Difference in ocular itching scores favored DEX over PV: 0.86 units at 3 min, 0.98 units at 5 min and 0.96 units at 7 min. For secondary endpoints at all other visits, subjects treated with DEX did better than PV for ocular itching scores post-CAC for all time points (P<0.05 at all visits except Visit 5, 3 minutes). These data are consistent with prior Phase 2 and Phase 3A studies. There were no serious AEs (ocular or non-ocular) and no subjects required rescue. There were no subjects with elevated IOP.
The primary endpoint of the trial was successfully met; DEXTENZA provided a sustained reduction in ocular itching, demonstrating promise as a potential hands-free steroid alternative for patients with allergic conjunctivitis. DEXTENZA was generally safe and well-tolerated in this study.