March 9, 2004

News Release: Positive Results From Xibrom(TM) U.S. Phase III Trials

ISTA Pharmaceuticals, Inc. announced positive, statistically significant results from its initial analysis of the company's U.S. Phase III clinical trials of Xibrom(TM)(0.1% bromfenac sodium ophthalmic solution). A topical, twice-daily, non-steroidal anti-inflammatory solution, Xibrom is initially being developed for the treatment of ocular inflammation following cataract surgery.

In two double-masked, placebo-controlled U.S. Phase III studies conducted under a single protocol, a statistically significant proportion of patients treated with Xibrom achieved treatment success as compared to placebo. Treatment success was defined as the complete absence of ocular inflammation. In one study involving 296 patients at 20 study sites, more Xibrom-treated patients cleared their ocular inflammation at 15 days when compared to patients receiving placebo at a rate of 62.6 % versus 39.8%, respectively. In a second U.S. study, which involved 231 patients at 19 study sites, the rates of ocular inflammation clearance at the primary endpoint of 15 days were 65.8% for Xibrom-treated patients and 47.9% for patients receiving placebo. Statistical significance in each trial reached a p value of less than 0.01. The company's analyses showed that Xibrom's treatment effect was evident as early as day three in both trials. The primary endpoint for both studies was the proportion of patients with complete absence of ocular inflammation, as measured by an assessment of immune cells in the anterior chamber of the eye (cells) and cellular debris ('flare').

For each trial, the secondary efficacy analysis of inflammation clearance in patients only on assigned treatment (with no other medications administered) also showed a statistically significant benefit for Xibrom treatment at 15 days versus placebo. In the 20-site study, the rates of clearance were 57.6% for Xibrom and 23.5 % for placebo. In the 19-site study, the rates of clearance were 62.0 % for Xibrom and 31.5 % for placebo. Both studies, when analyzed separately, also showed that Xibrom was well tolerated with a very low incidence of ocular adverse events. The efficacy and safety findings were consistent with results of previous studies conducted in Japan by Senju Pharmaceuticals Co. Ltd.

Based upon the results of the two trials, ISTA plans to file a New Drug Application (NDA) for Xibrom with the U.S. Food & Drug Administration in the second quarter of 2004.

'We are very pleased with our Phase III results for each of the two trials, for which our initial analysis has shown that Xibrom dosed twice daily results in statistically significant efficacy with a low incidence of ocular irritation,'stated Vicente Anido, Jr., Ph.D., ISTA's Chief Executive Officer. 'Xibrom's twice-daily dosing should make it more convenient than and an important therapeutic advance over other non-steroidal anti-inflammatory drugs which are usually administered four times a day.'

Dr. Anido added, 'Based upon our current schedule for the NDA filing and assuming timely FDA review and approval, ISTA's marketing team could launch Xibrom in the United States in the first half of 2005.'

About the Clinical Trials

A total of 527 patients were enrolled in two randomized, double- masked, placebo-controlled studies under the same protocol at 39 sites in the U.S. Under the trial protocols patients who had undergone cataract surgery in one eye and baseline inflammation post surgery were randomly assigned to either Xibrom or placebo twice daily for 14 days. At entry to the studies, each patient's summed ocular inflammation score was at least grade three on a five point scale. Efficacy was assessed on Day 15 and was defined as complete absence of ocular inflammation. The secondary endpoint measured clearance of ocular inflammation in patients at day 15 for patients who only received the assigned treatment (with no other medications administered).

There will be a conference call today with ISTA management at 11:00 a.m. EST to discuss these results. If you would like to participate in the call, please dial 800-915-4836 from the United States or Canada or 973-317-5319 from outside North America. A playback of this call will be available today from approximately 1:00 p.m. EST through April 6 and may be accessed by dialing 800-428-6051 from the United States or Canada or 973-709-2089 from outside North America. The rebroadcast access code is 342917. In addition, this conference call will be webcast live and subsequently archived on ISTA's website at www.istavision.com.

Xibrom(TM) (bromfenac)

Xibrom is a topical non-steroidal anti-inflammatory compound for the treatment of ocular inflammation. Xibrom was launched in Japan in 2000 by Senju Pharmaceuticals Co. Ltd. ISTA acquired U.S. marketing rights for Xibrom in May 2002.

About ISTA

ISTA is a specialty pharmaceutical company focused on the development and commercialization of unique and uniquely improved ophthalmic products. ISTA's product candidates and programs seek to address serious diseases and conditions of the eye such as vitreous hemorrhage, diabetic retinopathy, glaucoma, ocular inflammation and hyphema. 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.


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: delays and uncertainties related to ISTA's research and development programs (including the difficulty of predicting the timing or outcome of ISTA's product development efforts and the FDA or other regulatory agency approval or actions); uncertainties and risks regarding market acceptance of ISTA's products if approved and the impact of competitive products; the continued availability of third party sourced products and raw materials on commercially reasonable terms; the scope, validity, and enforceability of patents related to ISTA's products and technologies and the impact of patents and other intellectual property rights held by third parties; and such other 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/A, as amended, for the year ended December 31, 2002 and its Quarterly Reports on Form 10-Q for the quarters ended March 31, June 30 and September 30, 2003. For additional information regarding ISTA, please visit ISTA Pharmaceuticals'Website at www.istavision.com.



CONTACT: TEL: +1-949-788-5311 Vince Anido

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TEL: +1-949-788-5302 Lauren Silvernail

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both of ISTA Pharmaceuticals



TEL: +1-212-213-0006 Justin Jackson, Media

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Lisa Burns or E. Blair Schoeb, Investors

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all of Burns McClellan,

for ISTA Pharmaceuticals, Inc.

Internet: http://www.istavision.com

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