Ista Vitrase supplement
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Ista submits sNDA Aug. 4 for use of its pending ophthalmic solution Vitrase (ovine hyaluronidase) "as a spreading agent to facilitate the dispersion and absorption of other drugs." The firm says it is pursuing the additional indication because of shortages of spreading agents, because no additional studies were needed, and because commercialization efforts could begin while the original NDA for vitreous hemorrhage is reviewed. Vitrase became "approvable" April 3 for treatment of vitreous hemorrhage...