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Vitrase “approvable”

Executive Summary

Allergan/ISTA Vitrase "approvable" for vitreous hemorrhage treatment (ovine hyaluronidase), FDA letter says. "FDA requested additional analysis of the existing data and an additional confirmatory clinical study based upon that analysis," ISTA said. FDA's Dermatologic & Ophthalmic Drugs Advisory Committee determined in March that existing data did not demonstrate efficacy, but said ISTA could analyze subgroups and effects on vision for further evidence of efficacy (1"The Pink Sheet" March 24, p. 33). "FDA also cited issues related to the drug substance and drug specifications," company said. FDA did not note any deficiencies in safety data, ISTA added...

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