BioCentury
ARTICLE | Clinical News

BromSite: Phase III data

January 20, 2014 8:00 AM UTC

Top-line data from 234 patients who underwent cataract surgery in the modified intent-to-treat (mITT) population of a double-blind Phase III trial showed that twice-daily BromSite met the primary endpoint of reducing post-surgical ocular inflammation from baseline to day 15 vs. the DuraSite vehicle alone (p=0.01). BromSite also met the secondary endpoint of reducing post-surgery pain (p<0.001) and the tertiary endpoint of reducing inflammatory flare (p<0.01) vs. vehicle alone. BromSite was well tolerated with no treatment-related serious adverse events reported. Patients received twice-daily vehicle or BromSite the day prior to surgery, the day of surgery and for 14 days thereafter. ...