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

Thomas Walters, Shamik Bafna, Steven Vold, Gary Wortz, Paul Harton, Jeffrey Levenson, John Hovanesian, Francis Mah, Joseph Gira, David Vroman, Reginald Sampson, John Berdahl, Thomas Elmer, and Robert J. Noecker

Background: These studies evaluated the safety and efficacy of a single-dose sustained release dexamethasone depot (DEXTENZA™, 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.