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Phase III Study Initiated for Bromfenac in Ocular Inflammation

IRVINE, Calif., Apr 24, 2003 /PRNewswire-FirstCall via COMTEX/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA) today announced that the Company has filed an Investigational New Drug application with the U.S. Food & Drug Administration (FDA) to begin a Phase III study of bromfenac. A topical, twice-daily, non-steroidal anti-inflammatory solution, bromfenac is initially being developed for the treatment of ocular inflammation following cataract surgery. The Phase III study is expected to commence during the second quarter of 2003 and take place at more than twenty-five treatment centers in the U.S.

"Following initiation of the Phase III study, bromfenac will become ISTA's third product candidate in Phase III or beyond, a significant milestone for any specialty pharmaceutical firm," stated Vicente Anido, Jr., Ph.D., ISTA's Chief Executive Officer. "Based on the anticipated progress of the Phase III clinicals, we would expect to complete testing in late 2003. This timeline could allow us to launch bromfenac as early as 2005, assuming successful completion of our Phase III efforts and timely submission and approval by the FDA of our New Drug Application (NDA) for bromfenac."

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