Vitrase

Medical & Health Writers

IRVINE, Calif.--(BW HealthWire)--Dec. 10, 2001

ISTA Pharmaceuticals(TM), Inc. (Nasdaq: ISTA), today announced that on January 30, 2002 it will announce the preliminary efficacy results of its two Phase III clinical studies of Vitrase(R), a drug being developed by the Company for the treatment of patients with severe vitreous hemorrhage.

ISTA anticipates that collection of the balance of outstanding data from the study sites necessary to insure completion of a thorough and comprehensive quality review of all study documentation will soon be completed and entered into each study database. Following the collection of all the data and completion of the quality control review, each study database will be "locked" and the data will be transferred to one of ISTA's contract research organizations to permit the initial statistical analyses of data from the studies. To date, neither of the two Phase III study databases has been locked and no statistical analysis of the data from either of these studies has occurred.

One Phase III clinical trial is being conducted at investigational sites in the United States, Canada and Mexico and the other Phase III clinical trial is being conducted at investigational sites in Europe, Brazil, Australia and South Africa. A total of 1,190 patients were targeted for enrollment in the prospective, double-masked, randomized, placebo-controlled Phase III clinical trials. Patient enrollment in both studies has been completed. In both studies, patients with a vitreous hemorrhage for more than one month were eligible if the vitreous hemorrhage was severe and their best corrected visual acuity was worse than 20/200 at the time of entry into the study. Safety and efficacy assessments were made during regularly scheduled visits with efficacy determined during the 90-day period following treatment.

Currently, the only medical treatment for vitreous hemorrhage is surgery. Vitrase has received "fast-track" designation from the FDA for the treatment of vitreous hemorrhage. Based on market research ISTA commissioned in 1999, ISTA believes that approximately 450,000 cases of vitreous hemorrhage occur each year in the United States and that approximately half of these cases may be candidates for treatment using Vitrase.

ISTA Pharmaceuticals, based in Irvine, Calif., is focused on saving and improving eyesight by developing proprietary therapeutic products using the unique properties of the enzyme hyaluronidase. ISTA's product candidates and programs address serious diseases and conditions of the eye such as vitreous hemorrhage, diabetic retinopathy, corneal opacification and keratoconus.

This press release contains "forward looking statements" regarding the Company's plans to announce the preliminary efficacy results for the Phase III studies of Vitrase and the number of patients that would be candidates for using Vitrase. These statements are based on current expectations of future events and, as such, involve risks and uncertainties which may cause results to differ materially from those set forth in such statements. These risks and uncertainties include whether or not the Company completes the collection of the outstanding data from the Phase III studies, completes the entry of all necessary data into the study databases and completes the statistical analyses in a timely manner. In addition, the number of patients that would be candidates for using Vitrase depends on whether or not the drug receives FDA approval and the nature of that approval. Further information on the risks and factors that could affect ISTA's business, financial condition, and results of operations are contained in the company's public disclosure filings with the U.S. Securities and Exchange Commission (SEC), including the Company's quarterly report on Form 10-Q for the quarter ended September 30, 2001 which are available at www.sec.gov.

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