Two clinical trials of an intraocular steroid delivery system for cataract surgery.
OBJECTIVE
To determine the safety and efficacy of an intraocular dexamethasone drug delivery system (Surodex) in the treatment of inflammation following cataract surgery.


METHODS
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 to treatment with a placebo drug delivery system and to no anti-inflammatory drug treatment at all. Study 2 was a separate prospective, randomized, double-masked study of 60 cataract surgical patients that compared treatment with Surodex to topical dexamethasone (eye drop) therapy.


RESULTS
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. The majority of Surodex patients did not require topical steroid 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 following surgery. There were no significant adverse complications of Surodex in either study.


CONCLUSIONS
Surodex was safe and effective in suppressing postcataract surgery inflammation and appears to be a promising alternative to topical steroids.
Chang
D F
DF
Altos Eye Physicians, Los Altos, California, USA.
Wong
V
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D000368:Aged; D000867:Anterior Chamber / Q000187:drug effects; D003907:Dexamethasone / Q000008:administration & dosage* / Q000627:therapeutic use; D004311:Double-Blind Method; D016503:Drug Delivery Systems; D004343:Drug Implants; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000627:therapeutic use; D006801:Humans; D015863:Iridocyclitis / Q000209:etiology / Q000517:prevention & control*; D019654:Lens Implantation, Intraocular; D009883:Ophthalmic Solutions / Q000008:administration & dosage; D018918:Phacoemulsification / Q000009:adverse effects*; D011446:Prospective Studies; D012449:Safety; D016896:Treatment Outcome
D004343:Drug Implants; D005938:Glucocorticoids; D009883:Ophthalmic Solutions; D003907:Dexamethasone