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FORMULARY FORUM

Retisert: Is the New Advance in Treatment of Uveitis a Good One?

at time of writing, General Pharmacy Practice Resident, University of Michigan Health System and College of Pharmacy, University of Michigan, Ann Arbor, MI; now, Critical Care Pharmacy Practice Resident, University of Michigan Health System and College of Pharmacy

Burgunda V Sweet, PharmD

Director, Drug Information and Investigational Drug Services and Clinical Associate Professor of Pharmacy, University of Michigan Health System and College of Pharmacy

Susan G Elner, MD

Associate Professor of Ophthalmology, WK Kellogg Eye Center, University of Michigan Health System and School of Medicine

Reprints: Dr. Sweet, Department of Pharmacy Services, Drug Information Center, University of Michigan Hospitals and Health Centers, Room B2D301, University Hospital, 1500 E. Medical Center Dr., Ann Arbor, MI 48109, fax 734/936-7027, gsweet{at}umich.edu

OBJECTIVE: To review the use of corticosteroids for the treatment of uveitis, with a focus on the pharmacology, efficacy, and safety of a newer delivery device, Retisert.

DATA SOURCES: A PubMed/MEDLINE search from 1950 through February 2007 was conducted, and manufacturer-provided data were reviewed.

STUDY SELECTION AND DATA EXTRACTION: Animal studies and Phase II and III clinical trials evaluating the safety and efficacy of Retisert for the treatment of uveitis were considered. The data were extracted from PubMed/MEDLINE using the search terms fluocinolone acetonide, corticosteroids, intravitreal implant, uveitis, ocular steroids, and Retisert.

DATA SYNTHESIS: The findings of the clinical studies showed, with use of Retisert, a reduction in the recurrence of uveitis, improvement in visual acuity, and a decreased need for adjunctive therapy with corticosteroids and immunosuppressant agents. There are currently no studies directly comparing Retisert with other treatment options. The most commonly reported adverse events (ADEs) in clinical trials included cataracts, increased intraocular pressure, post-procedural complications associated with implant insertion, and ocular pain. Other ocular ADEs included decreased visual acuity, glaucoma, blurred vision, an abnormal sensation in the eye, eye irritation, and a change in tearing. These ADEs are similar to those seen with chronic corticosteroid therapy delivered by other ocular routes.

CONCLUSIONS: Retisert implants have been shown to deliver sufficient drug for a longer period of time compared with the traditional steroid delivery methods. Promising efficacy results show a significant reduction in recurrence rate and improvement in visual acuity for approximately 3 years after implant. However, the drug carries the risks associated with the implant procedure and with chronic exposure of the eye to steroids. Until more data on the long-term safety are known, Retisert should be reserved for patients who are no longer tolerant of or responsive to more traditional treatment modalities.

Key Words: fluocinolone acetonide, intravitreal implant, ocular steroids, uveitis

Published Online, March 6, 2007. www.theannals.com, DOI 10.1345/aph.1H540

THIS ARTICLE IS APPROVED FOR CONTINUING EDUCATION CREDIT
ACPE UNIVERSAL PROGRAM NUMBER: 407-000-07-010-H01