Two clinical trials of an intraocular steroid delivery system for cataract surgery.

Abstract

The authors determined the safety and efficacy of an intraocular dexamethasone drug delivery system (Surodex) in the treatment of inflammation after cataract surgery. Surodex is a biodegradable polymer that releases dexamethasone for 7 to 10 days after placement in the anterior segment. Study 1 was a prospective, randomized, double-masked phase II clinical trial of 90 cataract surgical patients that compared treatment with Surodex with treatment with a placebo drug delivery system and with no anti-inflammatory drug treatment. Study 2 was a separate prospective, randomized, double-masked study of 60 cataract surgical patients that compared treatment with Surodex with topical dexamethasone therapy. In the first study, Surodex was superior to placebo in suppressing postsurgical inflammation throughout the 60-day postoperative period, as judged by masked evaluator slit-lamp grading of cell and flare. The differences were statistically significant from postoperative day 3 through postoperative week 3. Most Surodex patients did not require topical corticosteroid by 2 weeks after surgery (93%) or by 2 months after surgery (88%). In the second study, Kowa laser flare meter readings were lower in Surodex patients throughout the 90-day postoperative period. The results were statistically significant at 4, 8, and 15 days after surgery. There were no notable adverse complications of Surodex in either study. The authors concluded that Surodex was safe and effective in suppressing postcataract surgery inflammation and appears to be a promising alternative to topical corticosteroids.—Thomas J. Liesegang