Inspire diquafosol response
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Inspire responds to a December 2003 "approvable" letter for its dry eye agent diquafosol requesting an additional clinical study, the firm announces June 1. "The focus of the NDA amendment is on multiple analyses of ocular surface staining, including corneal staining and conjunctival staining," Inspire said. The company has completed two additional Phase III trials since its initial submission of the P2Y2 receptor agonist in June 2003. The diquafosol pivotal program had mixed results, with one trial failing to show significance versus placebo for the primary endpoint of corneal staining...