Healthcare Industry News: Xibrom
News Release - January 30, 2006
ISTA Pharmaceuticals Receives FDA Approval for Expanded Indication of Xibrom(TM) to Treat Pain Following Cataract SurgeryPivotal Trial Results Demonstrated 75% of Patients with Pain Became Pain-Free within Two Days of Xibrom Treatment
Xibrom Previously Approved in March 2005 for the Treatment of Ocular Inflammation following Cataract Surgery
IRVINE, Calif., Jan. 30 (HSMN NewsFeed) -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA ) today announced that the U.S. Food & Drug Administration (FDA) has approved ISTA's supplemental New Drug Application (sNDA) for Xibrom(TM) (bromfenac ophthalmic solution) 0.09%, expanding Xibrom's indications to include the treatment of pain following cataract surgery. Xibrom(TM), 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. ISTA launched Xibrom in the U.S. during the second quarter of 2005.
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 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 III 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, with total prescriptions of 8.6 million.
For additional information on Xibrom, including full prescribing information, please visit http://www.istavision.com/products/products_Xibrom.asp.
ISTA is a specialty pharmaceutical company focused on the development and commercialization of unique and uniquely improved ophthalmic products. ISTA's products and product candidates seek to address serious diseases and conditions of the eye such as dry eye, vitreous hemorrhage, diabetic retinopathy, hyphema, glaucoma and inflammation. Building on this pipeline, ISTA's goal is to continue its growth as a specialty pharmaceutical company by acquiring complementary products, either already marketed or in late-stage development. For additional information regarding ISTA, please visit ISTA Pharmaceuticals' Website at http://www.istavision.com/.
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements. ISTA disclaims any intent or obligation to update any forward-looking statements. Such statements are based on ISTA's expectations as of the date of this press release and are subject to risks and uncertainties that could cause actual results to differ materially. Important factors that could cause actual results to differ from current expectations include, among others: risks and uncertainties related to the timing, scope and outcome of FDA and other governmental agency actions and decisions; uncertainties and risks regarding market acceptance of Xibrom, including but not limited to the impact of competitive products and pricing; uncertainties and risks related to ISTA's ability to continue to sufficiently develop and expand its sales, marketing and distribution capabilities and properly manage its growth; uncertainties and risks related to the availability on a timely basis of third party sourced products (including Xibrom) on commercially reasonable terms; and such risks and uncertainties as detailed from time to time in ISTA's public filings with the U.S. Securities and Exchange Commission, including but not limited to ISTA's Annual Report on Form 10-K for the year ended December 31, 2004 and ISTA's Quarterly Reports on Form 10-Q for the quarters ended March 31, 2005, June 30, 2005 and September 30, 2005.
Source: ISTA Pharmaceuticals
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