Phase II results of an intraocular steroid delivery system for cataract surgery

Objective: To evaluate the safety and efficacy of an intraocular biodegradable polymer dexamethasone drug delivery system (DEX DDS) in treating postoperative inflammation after cataract surgery, Study Design: Multicenter, randomized, double-masked, parallel group study comparing two dose levels of the DEX DDS to concurrent placebo and no treatment control subjects. Participants: Ninety patients scheduled to undergo extracapsular cataract extraction with phacoemulsification and intraocular lens implantation participated in the study. Intervention: One or two DEX DDSs, each containing 60 mu g of dexamethasone, were placed in the posterior chamber after cataract surgery. Patients receiving the placebo received a DDS composed of the same matrix with no active drug. In vivo rabbit studies have determined that the DEX DDS releases dexamethasone into the anterior chamber (AC) for approximately 7 to 10 days. Main Outcome Measures: The AC cells and the AC flare were assessed over a 60-day postoperative period using slit-lamp examination by masked observers, The number and percent of patients in each treatment group requiring additional postoperative topical anti-inflammatory medication were compared. Results: Ninety patients were randomized into 4 treatment groups (30 to the 2 DEX DDS group, 30 to the 1 DEX DDS group, 15 to the placebo DDS group, and 15 to the no treatment group). The control patients required the addition of topical steroids as rescue medication more frequently and sooner than patients receiving DEX DDS (80% vs. 7% at week 2) (P < 0.001). Patients receiving DEX DDS showed a significant reduction in postoperative inflammation as assessed by the combined AC cell and flare scores when compared to the control group from day 3 (P = 0.002) through week 3. The DEX DDS was well tolerated. No clinically significant difference in any safety evaluations, including intraocular pressure, was seen between the DEX DDS-treated and control groups. Conclusion: The DEX DDS was safe and effective in suppressing postoperative inflammation after uncomplicated cataract surgery. Additional topical anti-inflammatory drops were not needed for most patients.