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Ganciclovir Implant More Effective Than IV Therapy for CMV Retinitis CLAREMONT, CALIF. -- July 15, 1997 -- New data reported in the New England Journal of Medicine indicates that sustained-release ganciclovir (Cytovene; Roche Laboratories) intraocular implant (Vitrasert; Chiron Vision) significantly delays the onset of cytomegalovirus (CMV) retinitis in people with AIDS compared to standard IV therapy. The Vitrasert Implant which delivers ganciclovir to the site of CMV retinitis offered significant improvement over intravenous ganciclovir, reducing the risk of disease progression by nearly three-fold. "Vitrasert is an increasingly compelling new treatment strategy for patients with AIDS related CMV retinitis," said Daniel Martin, MD, Emory University and one of the study authors. "We have confirmed that the Vitrasert Implant significantly delays the progression of CMV retinitis in the treated eye and is the most effective treatment for CMV retinitis to date." CMV disease is one of the most common opportunistic infections to strike people with AIDS and can affect organs throughout the body ("systemic" disease) causing life-threatening infections. CMV retinitis is the most frequent manifestation of CMV disease, affecting an estimated 15-40 percent of patients with AIDS. It usually begins as a white infiltrate within the retina, and can progress rapidly to cause destruction of retinal tissue. Retinal damage can lead to detachment of the retina and permanent loss of vision. "It is important to note that people with AIDS may still be at risk for developing CMV disease in the other eye or in other organs," concluded Dr. Martin. Study authors noted that because patients treated with the Vitrasert Implant alone remained at risk for the development of CMV disease outside the treated eye, oral systemic treatment with ganciclovir may be recommended in addition to the implant. The randomized multi-center study was conducted with 188 patients with AIDS and newly diagnosed CMV retinitis. Results showed that the median time to progression of retinitis was 221 days with the 1-ug-per-hour implant and 191 days with a 2-ug-per-hour implant, compared with 71 days with ganciclovir administered intravenously. A total of 13 extraocular cytomegalovirus infections were reported in 12 of 117 patients in the two implant groups (10.3 percent) and in none of the 56 patients in the intravenous ganciclovir group. The Vitrasert Implant was approved by the U.S. Food and Drug Administration (FDA) in 1996 and approved by the European Agency for the Evaluation of Medicinal Products (EMEA) for marketing in Europe in March, 1997. The Vitrasert Implant is surgically placed in the posterior segment of the eye in a procedure that takes less than one hour, requires only local anesthesia and is conducted in an outpatient, day-surgery setting. Immediately following insertion of the implant, most patients experienced blurred vision, which generally cleared within two to four weeks. The implant can be removed when depleted of drug, usually within six to eight months and a new Vitrasert Implant can be inserted. More information on: Roche, Cytovene, Chiron Vision E-mail this page to a friend or colleague! To print, use this version