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Ista Vitrase Launch Set For Early 2005 With Approval Of Smaller Vial Size

This article was originally published in The Pink Sheet Daily

Executive Summary

Company plans to differentiate the spreading agent based on preservative-free formulation and 200 unit/mL vial size. Inability to fully characterize hyaluronidase results in Vitrase and Amphadase both having new molecular entity status. Ista is in discussions with FDA about “approvable” letter for vitreous hemorrhage indication.
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