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Once Daily Timolol Approved by FDA

IRVINE, Calif., June 7 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA) today announced that the U.S. Food & Drug Administration ("FDA") has approved the New Drug Application ("NDA") for ISTALOL(TM), a once- a-day liquid formulation of timolol, for the treatment of glaucoma.

Thomas K. Mundorf, M.D., a leading ophthalmologist and a clinical investigator for the U.S. ISTALOL(TM) clinical studies, commented, "Because glaucoma is a serious, chronic disease that must be treated for life, it is important to offer patients alternatives in their treatment regimen. ISTALOL(TM) gives patients an effective, therapeutic option with the convenience of a once-daily formulation. I believe that this is an advance that patients and their caregivers will greatly appreciate."

ISTALOL(TM) is ISTA's second product approved by the FDA. In May, ISTA announced FDA approval of ISTA's NDA for Vitrase(R) (hyaluronidase for injection; lyophilized, ovine) for use as a spreading agent to facilitate the dispersion and absorption of other drugs.

Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA stated, "We're very pleased to receive approval for our second commercial product, ISTALOL(TM) for the treatment of glaucoma, an estimated $1.1 billion market in the U.S. To compete most effectively in this market, we have assembled an experienced sales and marketing team that has been working with Ventiv Health, Inc. to recruit a dedicated sales force to promote ISTALOL(TM) to glaucoma specialists and general ophthalmologists. We anticipate launching ISTALOL(TM) within the next few months after we have secured sufficient commercial quantities for launch from our manufacturer." According to data compiled by NDC Health, ISTA estimates that U.S. ophthalmic beta-blocker sales currently exceed $170 million per year, with over 4.4 million prescriptions written annually.

ISTALOL(TM) is a once-daily, topical solution of timolol, a beta-blocking agent for the treatment of glaucoma. ISTA holds exclusive marketing rights to ISTALOL(TM) in the United States under an agreement with Senju Pharmaceutical Co., Ltd., which developed the product in Japan. Senju Pharmaceutical Co., Ltd, is a leading Japanese ophthalmic pharmaceutical company with a pipeline of innovative drugs.

In September 2002, Senju submitted the NDA for ISTALOL(TM) to the FDA based on data from a Phase I clinical study and a multi-center Phase III clinical trial completed in the United States. In the clinical trials, once- daily ISTALOL(TM) showed efficacy and safety comparable to twice-daily timolol maleate ophthalmic solution, which is the leading beta-blocker to treat glaucoma in the U.S. Advantages of ISTALOL(TM) include enhanced corneal penetration, as demonstrated in animal studies, and once-daily administration. Other formulations of timolol currently on the market are commonly prescribed as twice-daily solutions or gel formulations. Gel formulations, in particular, have been shown to cause blurring of patients' vision.

ISTALOL(TM) is a branded, patent-protected product. ISTA believes that ISTALOL(TM) may be eligible to receive certain FDA statutory exclusivity rights and therefore, if granted by FDA, ISTALOL(TM) will not be immediately substitutable by any of the generic timolol products currently on the market.

Source: Ista Pharmaceuticals

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