Twice-Daily Dosing Of Xibrom(TM) As Equivalent To Four Times A Day Of Other Treatments, Study

Main Category: Eye Health / Blindness
Also Included In: Clinical Trials / Drug Trials
Article Date: 05 May 2006 - 0:00 PDT

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ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA) announced today the presentation of data from a physician- sponsored clinical trial designed to compare the efficacy of Xibrom(TM) (bromfenac ophthalmic solution) 0.09% with two topical non-steroidal anti- inflammatory solutions (NSAIDs) that were given four times a day for the treatment of acute pseudophakic cystoid macular edema (CME). Xibrom(TM) is a topical, twice-daily NSAID approved by the U.S. Food & Drug Administration (FDA) for the treatment of ocular inflammation and reduction of pain following cataract surgery. The data were presented in a poster session during the 2006 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, currently being held in Fort Lauderdale, Florida.

According to the results of the trial, patients treated with Xibrom(TM) achieved statistically significant improvements in both visual acuity and EDTRS letters gained, which were equivalent to Voltaren Ophthalmic(R) (diclofenac sodium ophthalmic solution) 0.1% and Acular(R) (ketorolac tromethamine ophthalmic solution) 0.5% after three months of treatment. Under the study protocol, 52 patients with pseudophakic cystoid macular edema following cataract surgery were randomized to treatment according to one of three regimens: Xibrom(TM) one drop twice daily, Voltaren Ophthalmic(R) one drop four times daily, and Acular(R) one drop four times daily. Each patient was examined monthly for three months and measured for improvement in visual acuity using standardized ETDRS charts. None of the ophthalmic NSAIDs are indicated for the prevention or treatment of CME, an occasional complication of ocular surgery caused by swelling of the focusing area of the retina that can impair vision, although prior clinical investigations have demonstrated activity by the class in the condition.

The clinical findings were presented today at the 2006 ARVO Annual Meeting in a scientific poster session (# B626) entitled, "Bromfenac 0.09% versus Diclofenac Sodium 0.1% versus Ketorolac Tromethamine 0.5% in the Treatment of Acute Pseudophakic Cystoid Macular Edema."

"The reported clinical findings demonstrate that Xibrom's enhanced potency and penetration lead to equivalent results with fewer applications each day, which may translate into a real benefit to patients from the financial and convenience perspectives," commented Lisa R. Grillone, Ph.D., Vice President of Clinical Research at ISTA Pharmaceuticals. "Other studies have shown that reducing the number of daily doses greatly increases treatment compliance with ophthalmic medications. We believe that improving compliance in this way can have a direct impact on clinical outcomes, particularly for treatments lasting several months or involving several different medications."

UT XIBROM(TM) AND THE U.S. OPHTHALMIC ANTI-INFLAMMATORY MARKET

Xibrom(TM) (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(TM) in May 2002 under a license from Senju.

ISTA completed two pivotal Phase III clinical studies of Xibrom(TM) in the United States. In these studies involving 527 patients, a statistically significant proportion of patients treated with Xibrom(TM) 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(TM) group as early as day 3 following initiation of treatment. Furthermore, 75% of patients were pain-free within two days of being treated with Xibrom(TM) twice daily. In addition, 93% of patients receiving Xibrom(TM) 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 2005 prescription data from IMS, ISTA estimates that U.S. sales in 2005 in this market were approximately $400 million, with total prescriptions of 8.8 million.

For additional information on Xibrom(TM), including full prescribing information, please visit
http://www.istavision.com/products/products_xibrom.asp .

ABOUT ISTA

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, ocular pain and inflammation. Building on this pipeline, ISTA's goal is to continue its growth as a specialty pharmaceutical company through a combination of its own product development efforts and by acquiring complementary products and product candidates. 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. 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, 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, 2005.

ISTA Pharmaceuticals, Inc.
http://www.istavision.com

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