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Xibrom QD(once-daily)

XIBROM QD is our new proprietary once-daily formulation of Xibrom for the treatment of ocular pain and inflammation associated with cataract surgery. We believe that Xibrom QD can potentially improve patient compliance by reducing the number of daily doses to one a day, while maintaining effectiveness. In February 2007, we announced highly statistically significant and positive preliminary results from our initial analysis of our two U.S. Phase III clinical trials of our Xibrom QD. The multi-center studies evaluated Xibrom QD versus placebo in over 500 patients who underwent cataract surgery. The preliminary results of the Xibrom QD Phase III trials demonstrated Xibrom QD was highly statistically significant in treating post-operative ocular pain and inflammation associated with cataract surgery. Based upon our preliminary analyses of the Phase III data, the safety profile of Xibrom QD is consistent with our currently marketed Xibrom twice-daily formulation. Based upon the preliminary results of the Xibrom QD Phase III studies and pending final analyses, we plan to file a supplemental New Drug Application, or sNDA, with the FDA in the second half of 2007 for Xibrom QD for the treatment of ocular pain and inflammation associated with cataract surgery.


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