(BETA) News Briefs: Chiron Seeks Approval for Ganciclovir Implant

(BETA) News Briefs: Chiron Seeks Approval for Ganciclovir Implant

Bulletin of Experimental Treatments for AIDS, No. 26 September 1995
Ronald Baker, PhD

Chiron Vision, in cooperation with Hoffmann-La Roche, has asked FDA for approval to market Vitrasert, an ocular implant that delivers ganciclovir directly into the eye to treat cytomegalovirus (CMV) retinitis. CMV retinitis may cause partial or total loss of vision in people with AIDS.

The filing of the New Drug Application (NDA) for Vitrasert stems from the favorable results of 2 studies which indicate that the ganciclovir implant offers a clinical improvement over intravenous (IV) ganciclovir in delaying the progression of CMV retinitis (186 days versus 72 days). The Vitrasert implant may represent an important step forward in the treatment of CMV retinitis. However, some clinicians have expressed concerns about possible adverse complications from the surgical procedure used for the implant, including bleeding and partial or complete blindness. See page 73 of the March 1995 issue of BETA.

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