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Uveitis recurrence rate lowered, adjunctive therapy reduced with Retisert implant

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FORT LAUDERDALE, Fla. — Patients who received a sustained-release fluocinolone acetonide implant had a significantly lower rate of uveitis after implantation than in the year before implantation, according to Glenn J. Jaffe, MD. The need for adjunctive therapy was also reduced in treated eyes, he said.

Dr. Jaffe presented results of a 2-year phase 2b/3 study of the device here at the Association for Research in Vision and Ophthalmology meeting. Retisert (fluocinolone acetonide intravitreal implant, Bausch & Lomb) is an extended-release implant, designed to deliver the corticosteroid to the back of the eye over a period of approximately 2.5 years. The device was approved for treatment of posterior uveitis by the Food and Drug Administration in April.

“There was a low rate of recurrence of uveitis,” Dr. Jaffe said during a press briefing. “The use of systemic steroids, immunosuppressant or periocular injections was also reduced significantly in patients implanted with the device.”

In the study, 278 patients with uveitis were randomized to implantation in one eye with either a 0.58 mg or 2.1 mg formulation of Retisert. The uveitis recurrence rate before implantation in the treated eye and the rate in the untreated fellow eye were used as controls.

The recurrence rate in treated eyes declined from 59.7% before implantation to 5.4% after implantation at 1 year postop. By 2 years, the eyes implanted with the Retisert device had a recurrence rate of 11.2%, compared with more than a 50% recurrence rate in the untreated fellow eyes. This difference was statistically significant, Dr. Jaffe said

“The recurrence rate dropped dramatically in the study eye, whereas in the fellow eye it actually increased dramatically from 25.4% at baseline,” he noted.

The need for adjunctive therapy with steroids or immunosuppressant in the study eyes was reduced by 2 years postop, from 52.5% to 12.5%, and the need for periocular injection of steroids was reduced from 68% to 9.7%, Dr. Jaffe said. In the fellow eyes, the need for adjunctive therapy increased from 30.4% prior to study enrollment to 45.3% after study enrollment.

The Retisert implant is expected to become available this summer, according to Bausch & Lomb.