Based upon preliminary analyses, the safety profile is consistent with the currently marketed Xibrom formulation.
The Xibrom once-daily formulation contains both a higher concentration of the active ingredient, bromfenac, and a new formulation compared to the original twice-daily product.
According to Ista, if approved, this Xibrom formulation will provide patients with the most significant improvement to date in treating ocular pain and inflammation associated with cataract surgery, as it will be the only available once-a-day treatment.
Based upon the preliminary results of the studies and pending final analyses, Ista plans to file a supplemental new drug application with the FDA in the second half of 2007.