11l16I2015
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`FDA Approves Expaxhd lnria-lion for )Gbran b Trea Pa'n Following Caaact Sugary — Drugpcom Me:News
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`% Drugs.com
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`Know more. Be sure.
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`FDA Approves Expanded Indication for Xibrom to
`Treat Pain Following Cataract Surgery
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`IRVINE, Calif., January 30, 2006 — ISTA Pharmaceuticals, Inc. today announced that the U.S. Food & Drug
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`Administration (FDA) has approved lSTA's supplemental New Drug Applition (sN DA) for Xibrom
`(bromfenac ophthalmic solution) 0.09%, expanding Xibrom's indications to include the treatment I?‘ of pain
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`following cataract surgery. Xibrom, a topical, twice-daily, non-steroidal anti-inflammatory solution (N SAID),
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`was originally approved by the FDA in March 2005 for the treatment of ocular inflammation following cataract
`surgeg E71‘. ISTA launched Xibrom in the U.S. during the second quarter of 2005.
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`Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA stated, "Since Xibrom's launch,
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`prescriptions 12' have grown rapidly, and the product has taken a lead position in our portfolio. We are excited
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`to receive this additional approval from the FDA, which we believe will expand the use of our product and
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`greatly facilitate our sales force initiatives reaching the market base of approximately 10,000 ophthalmologists
`in the U.S."
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`About Xibrom and the U.S. Ophthalmic Anti-Inflammatory Market
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`Xibrom (bromfenac ophthalmic solution) 0.09% is a sterile, topical, non-steroidal anti-inflammatory solution
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`for the treatment of ocular inflammation and gain I?‘ following cataract surgery. Senju Pharmaceutils Co.
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`Ltd. has marketed this product in Japan since 2000 with over 7.9 million uses since that time. ISTA acquired
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`U.S. marketing rights for Xibrom in May 2002 under a license from Senju.
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`ISTA completed two pivotal Phase III clinical studies of Xibrom in the United States. In these studies
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`involving 527 patients, a statistically signifint proportion of patients treated with Xibrom achieved treatment
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`success, defined as the complete absence of ocular inflammation compared to those patients who received
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`placebo. This effect was evident in the Xibrom group as early as day 3 following initiation of treatment.
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`Furthermore, 75% of patients who experienced pain after cataract surgery were pain-free within two days of
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`being treated with Xibrom twice daily. In addition, 98% of patients experiencing pain after cataract surgery
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`and receiving Xibrom twice daily were pain-free within six days of treatment.
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`The topical ophthalmic anti-inflammatory market consists of steroids, NSAIDS and combination products.
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`Based upon management estimates of sales and 2004 prescription data from IMS, U.S. sales in 2004 in this
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`market were approximately $400 million, with total prescriptions of 8.6 million.
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`Source: ISTA
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`Posted: January 2006
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`11/16I2015
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