`
`FDA Approves Expanded Indication for Xibrom to Treat Pain Follo.ving Cataract Surgery- Drugs.com MedNews
`
`~ Drugs.com
`(g@ Know more. Be sure.
`FDA Approves Expanded Indication for Xibrom to
`Treat Pain Following Cataract Surgery
`
`IRVINE, Calif., January 30,2006 --1ST A Pharmaceuticals, Inc. today announced that the U.S. Food & Drug
`Administration (FDA) has approved ISTA's supplemental New Drug Application (sNDA) for Xibrom
`(bromfenac ophthalmic solution) 0.09%, expanding Xibrom's indications to include the treatment 0' of pain
`following cataract surgery. Xibrom, a topical, twice-daily, non-steroidal anti-inflammatory solution (NSAID),
`was originally approved by the FDA in March 2005 for the treatment of ocular inflammation following cataract
`surgery 13'. ISTA launched Xibrom in the U.S. during the second quarter of 2005.
`
`Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA stated, "Since Xibrom's launch,
`prescriptions 13' have grown rapidly, and the product has taken a lead position in our portfolio. We are excited
`to receive this additional approval from the FDA, w hich we believe will expand the use of our product and
`greatly facilitate our sales force initiatives reaching the market base of approximately 10,000 ophthalmologists
`in the U.S."
`
`About Xibrom and the U.S. Ophthalmic Anti-Inflammatory Market
`
`Xibrom (bromfenac ophthalmic solution) 0.09% is a sterile, topical, non-steroidal anti-inflammatory solution
`for the treatment of ocular inflammation and pain 13' following cataract surgery. Senju Pharmaceuticals Co.
`Ltd. has marketed this product in Japan since 2000 with over 7.9 million uses since that time. ISTA acquired
`U.S. marketing rights for Xibrom in May 2002 under a license from Senju.
`
`ISTA completed two pivotal Phase Ill clinical studies of Xibrom in the United States. In these studies
`involving 527 patients, a statistically significant proportion of patients treated with Xibrom achieved treatment
`success, defined as the complete absence of ocular inflammation compared to those patients who received
`placebo. This effect was evident in the Xibrom group as early as day 3 following initiation of treatment.
`Furthermore, 75% of patients who experienced pain after cataract surgery were pain-free within two days of
`being treated with Xibrom twice daily. In addition, 98% of patients experiencing pain after cataract surgery
`and receiving Xibrom twice daily were pain-free within six days of treatment.
`
`The topical ophthalmic anti-inflammatory market consists of steroids, NSAIDS and combination products.
`Based upon management estimates of sales and 2004 prescription data from IMS, U.S. sales in 2004 in this
`market were approximately $400 million, w ith total prescriptions of 8.6 million.
`
`Source: ISTA
`
`Posted: January 2006
`
`http://www .drugs_ com/news/fda-approves-expanded-indication-xibrom-pain-follo.ving-cataract-surgery-1703. htm I
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`PAGE 1 OF 2
`
`SENJU EXHIBIT 2189
`INNOPHARMA v SENJU
`IPR2015-00903
`
`
`
`11/1&'2015
`
`FDA Approves Expanded Indication for Xibrom to Treat Pain Fd lo.ving Cataract Surgery - Drugs_com MedNews
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`http://www _drugs_com/news/fda-approves-expanded-indication-xibrom-pail}-fd lo.ving-cataract-surgery- 1703_htrn I
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