Once-daily Xibrom could be with us soon

Results of a Phase III trial of the once-daily formulation of Xibrom (ISTA Pharmaceuticals) for the treatment of ocular inflammation and pain associated with cataract surgery, has found it to be both safe and efficacious.

The multicentre study evaluated the once-daily formulation versus placebo in more than 500 patients who had undergone cataract surgery. Preliminary analyses of the results have found the safety profile to be consistent with the currently marketed twice-daily formulation of Xibrom.

ISTA plans to file a supplemental New Drug Application (sNDA) with the FDA during the second half of 2007.