Chiron's Vitrasert Gets FDA Recommendation

The US Food and Drug Administration's Ophthalmic and Dermatologic Advisory Committee has recommended that Chiron Vision's Vitrasert Implant (sustained-release ganciclovir) be approved for the treatment of cytomegalovirus retinitis in patients with AIDS. If approved, which seems likely since the FDA rarely ignores advisory panel recommendations, the product will become the first drug delivery implant available for this indication. Current treatment for the condition is achieved with intravenous ganciclovir, intravenous foscarnet or oral ganciclovir.

Vitrasert is designed to be surgically placed in the posterior segment of the eye where it allows diffusion of ganciclovir locally over an extended period of time. In Phase III trials, the product has demonstrated significant benefit over intravenous ganciclovir in delaying time to disease progression in AIDS patients newly-diagnosed with CMV retinitis. Data presented recently at the Interscience Conference on Antimicrobial Agents and Chemotherapy showed that treatment with Vitrasert was associated with a median time to progression of disease of 194 days, compared with 72 days for placebo.

Implant Advantageous Over IV Commenting the product, Baruch Kuppermann of the Department of Ophthalmology at the University of California, USA, said that sustained, ocular release of ganciclovir for six months or more eliminates the need for a central venous catheter, as is used in chronic intravenous treatment. In addition, studies have shown clinical utility for the product in patients whose retinitis has progressed despite systemic treatment or who are intolerant of the currently-available drugs, according to Judy Gorden, vice president of scientific affairs at Chiron Vision.