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ISTA To Promote Vitrase With Istalol Reps After Regaining Rights

This article was originally published in The Pink Sheet Daily

Executive Summary

ISTA anticipates a $30 per vial price and a first quarter 2005 launch for the spreading agent following the reacquisition of rights from Allergan. ISTA is also planning a sales force expansion.

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

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.

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

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.

Amphastar's Spreading Agent Amphadase Clears FDA

Approval of a 150 unit/mL version could give Amphadase an advantage over Ista's hyaluronidase product Vitrase, which cleared FDA in May but is awaiting approval of a smaller, single-use vial. The enzyme drug has been in shortage since Wyeth discontinued Wydase in 2002.

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