Uveitis recurrence rate lower with steroid implant, surgeon says

ROCHESTER, N.Y. — The rate of recurrence of uveitis was lower in eyes implanted with a sustained-release steroid implant than in the non-implanted fellow eyes of patients in a comparative clinical study. Robert Devenyi, MD, reported 34-week data from the study at the Retina Society meeting.

Retisert (Bausch & Lomb) is a drug-delivery technology that in this trial contained fluocinolone acetonide for the treatment of noninfectious posterior uveitis. The international, randomized, dose-masked, multicenter trial included 239 patients with the disease who received either a 0.59 mg or 2.1 mg Retisert implant in one eye while the other eye remained implant-free, Bausch & Lomb reported in a press release. The trial was carried out at 19 centers in Australia, Canada, Hong Kong, India, the Philippines and the United States.

For the aggregate results of the two doses at 34 weeks, eyes that received the implant had a uveitis recurrence rate of 10% compared with 57% in eyes without the implant, the press release describing Dr. Devenyi’s presentation said. Statistically significant improvement in visual acuity was seen in the treated eyes, but no statistically significant improvement in mean VA occurred in the fellow eyes. Additionally, 20.9% of the implant eyes gained 3 or more Snellen lines.

A statistically significant decrease in the use of systemic corticosteroid or immunosuppressant therapy, use of periocular injections and use of topical steroid eye drops to control inflammation in the implanted eyes was found at the 34-week follow up, according to the press release.

Common adverse events included cataract progression and increased IOP, Bausch & Lomb noted, both of which would be expected with the type of drug used.

The unmasked results of the trials will be used in Bausch & Lomb’s application for approval by the Food and Drug Administration. Company executives are targeting commercialization of the implant in 2005, the release said.