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DEXTENZA®(dexamethasone ophthalmic insert) is a resorbable sustained-release intracanalicular insert delivering a 0.4 mg dose of dexamethasone over 30 days, designed to obviate the need for corticosteroid drops. Herein, a cumulative measure of drug effect, area under the curve (AUC) analysis was undertaken with DEXTENZA following cataract surgery.
Three prospective, double-masked, parallel-arm, vehicle-controlled Phase 3 studies were conducted. Adult subjects (n=926; >18 years) who had undergone cataract surgery with intraocular implantation on Day 1 were randomized to receive either DEXTENZA (DEX; n=541) or Placebo (PV; n=385), immediately following surgery; follow-up visits were at Days 2, 4, 8, 14, 30 and 45/60. Anterior chamber cell counts, flare and pain scores were captured at every visit. In the pooled phase 3 studies, post-hoc AUC analysis was performed to assess the cumulative effect on anterior chamber cell counts, anterior chamber cell flare scores, and pain scores with DEXTENZA compared to placebo.
Compared to patients treated with placebo (PV; n=375), the mean difference in anterior chamber cell count AUC outcomes in patients treated with DEXTENZA (DEX; n=528) was -15.28% (95% CI, -20.46, -10.10, p < .0001). Compared to patients treated with placebo (PV; n=376), the mean difference in anterior chamber cell flare score AUC outcomes in patients treated with DEXTENZA (DEX; n=528) was -13.73% (95% CI, -17.86, -9.60, p < .0001). Compared to placebo (PV; n=376), the mean difference in pain score AUC outcomes in patients treated with DEXTENZA (DEX; n=527) was -23.26% (95% CI, -32.31, -14.22, p < .0001).
AUC outcomes demonstrated herein suggest consistency of cumulative drug effect benefits with DEXTENZA compared to PV in phase 3 trials. Because DEXTENZA may obviate the need for corticosteroid drops following ophthalmic surgery, these data further support the totality of available DEXTENZA efficacy evidence for post-cataract inflammation and pain.