Vitreous Hemorrhage

ISTA Pharmaceuticals to proceed with NDA filing for Vitrase

Published in Blood Weekly, May 30th, 2002

ISTA Pharmaceuticals, Inc., (ISTA) announced that following discussions with the FDA, the company will be proceeding with the preparation and submission of the clinical and other required sections of the new drug application (NDA) for Vitrase for the treatment of vitreous hemorrhage.

Last month, ISTA announced the preliminary safety and efficacy results for two phase III clinical trials of a single injection of Vitrase for the treatment of severe vitreous hemorrhage. The company subsequently provided the FDA with preliminary study data analysis and has held discussions with the FDA regarding the analysis noting the improvement in visual function as measured by visual...

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Source: Blood Weekly (2002-05-30)

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