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Chiron Corporation, Emeryville, California, and Hoffmann-La Roche, Nutley, New Jersey, announced that Chiron's ophthalmic business, Chiron Vision, has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) to market Vitrasert, its intraocular implant which delivers ganciclovir directly to the eye for treatment of cytomegalovirus (CMV) retinitis.
CMV retinitis is the most common opportunistic infection and leading cause of blindness in people with AIDS. Currently, physicians can treat the disease with I.V. ganciclovir, foscarnet or oral ganciclovir.
The NDA filing is based on results of two independent Phase III clinical trials conducted by Chiron Vision and The National Eye Institute (NEI). The studies demonstrated that the Vitrasert ganciclovir implant offers a clinical improvement versus intravenous ganciclovir in further delaying progression of CMV …