The multi-center studies evaluated the new once-daily formulation of Xibrom versus placebo in over 500 patients who underwent cataract surgery. The highly statistically significant findings demonstrated Xibrom QD (once-daily) was superior to placebo (P less than or equal to 0.0001) in achieving both the primary efficacy endpoint of absence of ocular inflammation 15 days following surgery and the secondary efficacy endpoint of elimination of ocular pain at day one.
In addition, compared to placebo, bromfenac produced a lower overall incidence of ocular adverse events.
A total of 542 patients were enrolled in two randomized, double-masked, placebo-controlled studies under the same protocol at 39 sites in the US. Subjects were assigned randomly to receive either Xibrom once-daily or placebo (n=360) or (n=182). Dosing began one day before cataract surgery and continued through post-surgery day 14. Elimination of ocular pain was assessed at day one and complete absence of ocular inflammation was assessed on day 15.
Xibrom is a topical non-steroidal anti-inflammatory compound for the treatment of ocular inflammation and pain.