Inspire anticipates launching AzaSite in the latter part of the third quarter of 2007 and expects to generate $30 – $45 million in sales in the 2008 calendar year based on current manufacturing and commercial plans.
AzaSite will offer patients a reduced dosing regimen compared to other currently available products for bacterial conjunctivitis. The recommended dosing regimen for AzaSite is one drop twice-a-day for two days, followed by one drop once-a-day for the next five days, for a total of nine drops in the affected eye.
In two phase III clinical studies, AzaSite met the primary efficacy endpoint of clinical resolution in patients with confirmed bacterial conjunctivitis. Clinical resolution was defined as the absence of ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection. The most common adverse event in patients receiving AzaSite was eye irritation, which occurred in 1-2% of patients.
Inspire acquired exclusive rights to commercialize AzaSite for ocular infections in the US and Canada from InSite Vision in February 2007.