Results of a Phase 3, Randomized, Double-Masked, Vehicle Controlled Study
(Phase 3c) Evaluating the Safety and Efficacy of DEXTENZA^TM (dexamethasone insert) 0.4 mg for the Treatment of Ocular Inflammation and Pain after Cataract Surgery

Abstract

Purpose : To evaluate the safety and efficacy of DEXTENZA, an extended release dexamethasone insert, when placed in the canaliculus of the eye for the treatment of post-surgical inflammation and pain in subjects who have undergone cataract extraction with intraocular lens implantation.

Methods : This was a prospective, multicenter, randomized, parallel-arm, double-masked, vehicle controlled study. Subjects enrolled in the study were randomized (1:1) on Day 1 to receive either DEXTENZA or placebo vehicle insert (PV); the test article was inserted into the inferior vertical canaliculus of the operated eye intraoperatively, within minutes of the completion of cataract surgery. Subjects completed follow-up visits at post-operative Days 2, 4, 8, 14, 30 and 45. The primary endpoints evaluated were the absence of anterior chamber (AC) cells (score of 0) at Day 14 and the absence of pain (score of 0) at Day 8. Safety evaluations included adverse event (AE) collection, and ocular examination findings, including slit lamp, dilated fundus, visual acuity, and intraocular pressure exams.

Results : A total of 438 subjects were randomized into the study. Baseline demographics were similar across both cohorts. DEXTENZA met both primary efficacy endpoints, showing statistical superiority over PV; 52.3% of subjects receiving DEXTENZA had no AC cells at Day 14, compared to 31.1% of subjects receiving PV (p<0.0001), and 79.6% of subjects receiving DEXTENZA had no pain at Day 8, compared to 61.3% of PV subjects (p<0.0001). Statistical superiority of DEXTENZA over PV was observed as early as Day 2 for absence of ocular pain and Day 4 for absence of AC cells. Ocular AEs observed in >5% of subjects were limited to eye inflammation and increased intraocular pressure. There were no treatment-related serious AEs. No subjects experienced a treatment-emergent AE leading to subject withdrawal.

Conclusions : DEXTENZA was shown to be statistically superior to PV in treating post-surgical inflammation and pain in subjects having undergone cataract extraction; superiority over PV was observed as early as Day 2 for absence of ocular pain and Day 4 for absence of cells. Treatment with DEXTENZA was safe and well-tolerated.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

 

Summary of the Co-Primary Efficacy Endpoint Results

 

Summary of Adverse Events