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"Vitrasert is an increasingly compelling new treatment strategy for patients with AIDS related CMV retinitis. 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," said Daniel Martin, MD, Emory University and one of the study authors.
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.
Chiron Vision Corporation, headquartered in Claremont, California, researches, develops, manufactures, and markets products for the surgical correction of vision, including intraocular lenses (IOLs), phacoemulsification instruments, viscoelastics, corneal shapers, excimer lasers and drug delivery systems. Chiron Vision is among the world's leading sellers of IOLs and related products.
Chiron Corporation, headquartered in Emeryville, California, is a science-driven market-directed healthcare company that combines diagnostic, vaccine and therapeutic strategies for controlling disease. Chiron participates in four global healthcare markets: diagnostics, including immunodiagnostics, critical care diagnostics and new quantitative probe tests; therapeutics, with an emphasis on oncology and infectious disease; pediatric and adult vaccines; and ophthalmic surgical products for the correction of vision. Chiron also has research programs in gene therapy, combinatorial chemistry, cancer, infectious and cardiovascular disease, and critical care.
F. Hoffmann-LaRoche Ltd. is a research-based healthcare company with headquarters in Basel, Switzerland. Roche is a leading healthcare company dedicated to the research, development and delivery of diagnostic tests, treatment and services for people with life-threatening illnesses.
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CONTACT: Chiron Vision Missy Lowery, 800/352-1891 missy_lowery@cc.chiron.com or Chiron Corporation Jim Knighton, 510/923-3252 or Burns McClellan, Inc. Audra Nass, 415/352-6262
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