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ISTA Pharmaceuticals Announces Results of Clinical Trial of Xibrom(TM) QD (Once-Daily) Formulation
Date:4/1/2008

IRVINE, Calif., April 1, 2008 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today reported topline results of a clinical trial of Xibrom(TM) (bromfenac sodium ophthalmic solution) QD (once-daily) 0.18% formulation, a new formulation of ISTA's ocular, non- steroidal anti-inflammatory agent. The findings demonstrated equivalence between the 0.18% formulation and ISTA's 0.09% formulation of Xibrom given once daily in achieving the primary efficacy endpoint of absence of ocular inflammation 15 days following surgery. The data also showed no statistically significant difference between the two formulations in achieving the secondary efficacy endpoints of elimination of ocular pain and mean reduction of markers of inflammation (inflammatory cells and flare). In addition, the results indicated both formulations of bromfenac produced a low overall incidence of ocular adverse events.

"We undertook this trial in connection with our Xibrom QD NDA application, which was submitted to the FDA in December 2007. The nearly identical performance of the two concentrations was unexpected and inconsistent with the previously available data. The results suggest the 0.09% formulation is near the top of the dose-response curve," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA Pharmaceuticals. "Our next steps are to complete the data analysis and speak with the FDA to determine a possible path forward, as well as consider other options in terms of new Xibrom products. Part of our discussions will be to review the possibility of a label change for the currently marketed 0.09% formulation of Xibrom so that it can be administered once-daily."

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SOURCE ISTA Pharmaceuticals, Inc.
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