XiDay™ PDF Print E-mail

ISTA is developing a once-daily version of Xibrom, or XiDay, for the treatment of ocular inflammation and pain following cataract surgery. In August 2009, we announced positive preliminary Phase III results from our XiDay Phase III confirmatory clinical study. XiDay achieved statistical significance in the study’s primary endpoint, the absence of ocular inflammation 15 days following cataract surgery, and the secondary efficacy endpoint, the elimination of ocular pain one day post surgery. In December 2009 we filed a sNDA with the FDA seeking approval of the XiDay formulation for once-daily treatment for the inflammation and pain following cataract surgery. We were notified by the FDA in March 2010 about the Prescription Drug User Fee Act, or PDUFA, date of October 2010.