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| |  FDA Panel Recommends Vitravene For CMV Retinitis CARLSBAD, CA and ATLANTA, GA -- July 23, 1998 – The United States Food and Drug Administration’s ophthalmic drugs subcommittee of the dermatologic and ophthalmic drugs advisory committee has voted in favor of approving Vitravene(TM) (fomivirsen) for the treatment of cytomegalovirus (CMV) retinitis in AIDS patients. Vitravene is marketed by Isis Pharmaceuticals, Inc. and CIBA Vision Corp. Vitravene is an antisense inhibitor of CMV replication, the virus that causes retinitis. CMV retinitis is a degenerative opportunistic infection that affects people with AIDS and results in blindness. Vitravene is the first antisense drug to be filed for commercial marketing review. The new drug application for Vitravene was filed by Isis on April 9, 1998 and is being reviewed under the agency's priority review process. Vitravene, administered locally into the eye by intravitreal injection, was shown to be well-tolerated. The most frequently observed ocular side effects were transient increased intraocular pressure and generally mild to moderate, reversible intraocular inflammation. The retinal detachment rate overall in the Phase III program was considerably lower than the incidence of retinal detachment commonly observed in patients with CMV retinitis. There was no evidence of any systemic toxicity from Vitravene.
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