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Vitrase granted U.S. approval for use as spreading agent in anesthesia

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IRVINE, Calif. — Hyaluronidase will be available commercially in the United States for the first time in 3 years, following yesterday’s announcement of the regulatory approval of Vitrase from Ista Pharmaceuticals.

U.S. regulators approved Vitrase (ovine lyophilized hyaluronidase for injection) for use as a spreading agent to help with the dispersion and absorption of other drugs, according to a press release from the product’s marketer.

A previously available version of hyaluronidase, the Wyeth drug Wydase, was widely used in ophthalmic anesthesia before it was withdrawn from the market in 2001. A press release from Ista reported that before 2001, Wydase was used as a spreading agent in more than 750,000 ophthalmic surgeries annually.

Ista Pharmaceuticals noted in its release that the approval of Vitrase removes hyaluronidase from the Food and Drug Administration’s drug shortage list, where it has been since 2001. Vitrase is highly purified, preservative-free ovine hyaluronidase, according to the release.

Labeling for the drug will state, in part, that “Vitrase is indicated as an adjuvant to increase the absorption and dispersion of other injected drugs,” the Ista press release noted.

Vitrase will be available in a vial of 6,200 USP units. The labeling will contain instructions for reconstituting the drug in five dose concentrations, the company said.

Vicente Anido Jr., PhD, president and chief executive officer of Ista, said in the press release that the company will seek a supplemental new drug application for a smaller vial size of 150 USP units, which the company believes will be optimal for use as a spreading agent. This smaller vial size could be approved during the second half of 2004, Mr. Anido said.

Vitrase has also been studied for the treatment of vitreous hemorrhage, and an approvable letter was received for that indication in 2003. At the time, the FDA requested additional analysis of existing data and an additional confirmatory clinical study based upon that analysis. The drug has also been studied for treatment of diabetic retinopathy.