Efficacy and Safety of Sustained Release Dexamethasone for the Treatment of Ocular Pain and Inflammation after Cataract Surgery: Results from Two Phase 3 Studies

Background: These studies evaluated the safety and efficacy of a single-dose sustained release dexamethasone depot (DEXTENZATM, Intracanalicular Depot) for the treatment of pain and inflammation following cataract surgery. Methods: Patients were randomized (2:1) on Day 1 to receive a sustained release dexamethasone depot, (0.4 mg; Study 1, n=164; Study 2, n=161) or placebo vehicle depot (Study 1, n=83; Study 2, n=80) in the inferior canaliculus. Results: A significantly greater proportion of patients in the dexamethasone groups (Study 1, 80.4% [131/164] vs. 43.4% [36/83], P<0.0001; Study 2, 77.5% [124/161] vs. 58.8% [47/80], P=0.0025) had an absence of ocular pain at Day 8. At Day 14 more patients in the dexamethasone groups had an absence of anterior chamber cells (Study 1, 33.1% [54/164] vs. 14.5% [12/83], P=0.0018; Study 2, 39.4% [63/161] vs. 31.3% [25/80], P=0.2182). Statistically significant differences favoring dexamethasone were observed in both studies for proportions of patients with: an absence of ocular pain at days 2, 4, 8, and 14; an absence of anterior chamber flare at days 8 and 14; mean anterior cell scores at days 8 and 14. Significantly fewer patients in the dexamethasone groups required rescue medications on days 8 and 14. No serious adverse events related to treatment occurred in either group. Transient IOP increases of ≥ 10 mmHg in the study eye were observed in similar proportions of patients in the sustained release dexamethasone groups, (6.8% in Study 1 and 4.4% in Study 2) and the placebo groups (3.6% and 5.0%, respectively). However, only 1 incidence of IOP elevation was thought to be product related (0.3%). Conclusions: These two studies demonstrate that a single dose, sustained release dexamethasone intracanalicular depot is safe and effective for the treatment of ocular pain and inflammation following cataract surgery.