BioCentury
ARTICLE | Company News

InSite, Nicox deal

February 9, 2015 8:00 AM UTC

InSite granted Nicox exclusive rights to develop, manufacture and commercialize AzaSite, BromSite and AzaSite Xtra in Europe, the Middle East and Africa. Nicox expects to submit MAAs for AzaSite and BromSite in 1Q16 and launch launch one of them in late 2017. AzaSite is a 1% formulation of azithromycin, AzaSite Xtra is a 2% formulation of azithromycin and DuraSite is a low-dose formulation of NSAID bromfenac. The products use InSite’s DuraSite ophthalmic drug delivery system. AzaSite is approved in the U.S. and Canada to treat bacterial conjunctivitis. InSite plans to submit an NDA to FDA in 1Q15 for DuraSite to treat inflammation and prevent pain after cataract surgery. ...