The findings demonstrated equivalence between the 0.18% formulation and company’s 0.09% formulation of Xibrom given once daily in achieving the primary efficacy endpoint of absence of ocular inflammation 15 days following surgery. The data also showed no statistically significant difference between the two formulations in achieving the secondary efficacy endpoints of elimination of ocular pain and mean reduction of markers of inflammation. In addition, the results indicated both formulations of bromfenac produced a low overall incidence of ocular adverse events.
Vicente Anido, Jr., president and CEO of Ista, said: “We undertook this trial in connection with our Xibrom (bromfenac sodium ophthalmic solution) QD (once-daily) NDA application, which was submitted to the FDA in December 2007. The nearly identical performance of the two concentrations was unexpected and inconsistent with the previously available data. The results suggest the 0.09% formulation is near the top of the dose-response curve.”