Study: Low uveitis recurrence rate at 34 weeks with Retisert implant

ROCHESTER, N.Y. — Eyes implanted with a drug delivery device for treatment of uveitis had a lower recurrence rate than fellow eyes that did not receive an implant, according to information released by the device manufacturer.

Retisert (Bausch & Lomb) is an intravitreal implant containing fluocinolone acetonide. The device was implanted in 278 patients who were randomized to receive 0.5 mg or 2 mg dosing, for treatment of noninfectious posterior uveitis. In all cases the fellow eye served as control, according to a press release from Bausch & Lomb. Results of the study were presented by Glenn Jaffe, MD, at the Retina Society meeting in Chicago.

According to the release, Dr. Jaffe reported that at 34 weeks, the recurrence rate was statistically significantly lower (P < .0001) in the eyes with the implant (2.9%) than in fellow eyes (43.7%). Baseline mean visual acuity of 20/68 improved to 20/58 after implantation, the release noted. Slightly more than one-quarter of the Retisert eyes had an improvement in vision of three or more lines. Conversely, fellow-eye mean visual acuity decreased from baseline to follow-up.

Use of systemic corticosteroid and/or immunosuppressive therapy also decreased at 34 weeks. At baseline, 50% of patients were using one or both systemic therapies, compared with 13.7% at follow-up, according to the release. The need for periocular steroid injections also decreased in the treated eyes.

Dr. Jaffe reported that the most common adverse events included cataract progression and an increase in intraocular pressure, according to Bausch & Lomb.

The release said the company expects to file a new drug application with the Food and Drug Administration in mid-2004.