Safety and Efficacy of a Novel Intracameral Dexamethasone Drug Delivery Suspension for Treating Inflammation Associated With Cataract Surgery
To evaluate the safety and efficacy in treating postoperative inflammation of a dexamethasone drug delivery suspension for anterior chamber intracameral placement that provides drug for up to 21 days with a single application in patients undergoing cataract surgery.
In this prospective, randomized, double-masked, multicenter trial, 394 patients with preoperative BCVA of 20/30-20/200 undergoing unilateral cataract surgery by phacoemulsification were randomized 1:2:2 to receive 5 μL of placebo or 342 or 517 μg of dexamethasone drug delivery suspension placed into the anterior chamber at the conclusion of cataract surgery. Patients were followed for 90 days postoperatively. The primary outcome measure was the anterior chamber cell (ACC) clearing in the study eye at Day 8. Secondary outcome measures included anterior chamber flare (ACF) and anterior chamber cell + flare (ACCF) clearing in the study eye. Ocular and non-ocular adverse events were assessed.
The percentage of patients with ACC clearing at Day 8 was 25.0% in the placebo group, 63.1%, and 66.0% in the 342 and 517 µg treatment groups, respectively (P< .001). The percentage of patients with ACF clearing at Day 8 was 63.8% in the placebo group, 92.4%, and 89.1% in the 342 and 517 µg treatment groups (P< .001). The percentage of patients with ACCF clearing at Day 8 was 33.8% in the placebo group, 63.1%, and 67.3% in the 342 and 517 µg treatment groups (P<.001). No ocular serious adverse events were reported up to Day 90 and adverse events among the 3 groups were similar.
Dexamethasone drug delivery suspension placed in the anterior chamber at the conclusion of cataract surgery at concentrations of 342 and 517 µg was safe and effective in treating post cataract surgery inflammation and may be an alternative to corticosteroid drop installation in this patient population.