Chiron Corp.'s Vitrasert, an intraocular implantcontaining ganciclovir for treatment of cytomegalovirus(CMV) retinitis, won a recommendation for approvalFriday from the FDA's Dermatologic Drugs AdvisoryCommittee.
CMV retinitis, an opportunistic infection, affects about15 to 40 percent of AIDS patients and can lead toblindness. Current standard treatment is intravenousadministration of ganciclovir, an antiviral agent marketedby Roche Holdings Ltd., of Basel, Switzerland.
Judy Gordon, Chiron's vice president of scientific affairs,said studies used to support the new drug application(NDA) for Vitrasert, which delivers ganciclovir directlyto the eye, demonstrated it delayed progression of thedisease for 200 days compared with 70 days for systemicinfusion of the drug.
Vitrasert contains a polymer-based sustained release drugdelivery system that is surgically implanted. It releasesganciclovir over a period of months and can be replacedwhen empty.
Emeryville, Calif.-based Chiron's ophthalmic businessunit, Chiron Vision, has a collaboration with Roche tomarket and co-promote Vitrasert. The companies filed theNDA in July 1995.
Chiron's stock (NASDAQ:CHIR) closed Friday $106.75,up $2.25. _ Charles Craig
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