DEXTENZA^TM (extended release dexamethasone) 0.4 mg vs. Placebo for the Treatment of Ocular Pain after Cataract Surgery: Results of Three Phase 3 Studies

Abstract

Purpose : To evaluate the integrated efficacy of DEXTENZA when placed in the canaliculus of the eye for the treatment of post-surgical pain in subjects who have undergone cataract extraction with intraocular lens implantation.

Methods : Three prospective, multicenter, randomized, parallel-arm, double-masked, vehicle controlled Phase 3 clinical trials were conducted. Subjects enrolled in the study were randomized on Day 1 to receive either DEXTENZA or placebo vehicle insert (PV); the test article was inserted into the inferior canaliculus of the operated eye within minutes of the completion of surgery. Subjects completed follow-up visits at post-operative Days 2, 4, 8, 14, 30 and 45/60. Absence of pain (score of 0) at Day 8, as rated by the patient, was evaluated as a primary endpoint. 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 924 subjects were randomized into the study (n=539, DEXTENZA; n=385, PV). A pooled analysis of the primary endpoint showed that 79.2% of subjects receiving DEXTENZA had an absence of pain at Day 8, compared to 56.9% of PV patients (p<0.0001).

In Phase 3a, a significantly greater proportion of patients in the DEXTENZA group had an absence of pain at Day 8, compared to patients receiving PV (80.4% [131/164] vs 43.4% [36/83], p<0.0001). In Phase 3b, similar results were observed: 77.5% [124/161] vs. 58.8% [47/80], p=0.0025. In Phase 3c, DEXTENZA showed statistical superiority over PV; 79.6% (172/216) of subjects receiving DEXTENZA had pain at Day 8, compared to 61.3% (136/222) of subjects receiving PV (p<0.0001).

Across all three studies, a greater proportion of subjects in the placebo group experienced at least one ocular AE in the study eye as compared to patients receiving DEXTENZA. The most frequent ocular AEs were anterior chamber inflammation, increased IOP, corneal edema, and eye inflammation. There were no treatment-related serious AEs.

Conclusions : DEXTENZA was effective in treating post-surgical pain according to the integrated efficacy data, and across all three Phase 3 clinical trials. 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 Pain Data