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Xibrom

Generic name: bromfenac
Treatment for: Postoperative Ocular Inflammation

FDA Accepts ISTA Pharmaceuticals' New Drug Application for Xibrom

IRVINE, Calif., July 26, 2004-- ISTA Pharmaceuticals, Inc. (NASDAQ:ISTA) today announced that the U.S. Food & Drug Administration has accepted for filing and review ISTA's New Drug Application (NDA) for Xibrom (bromfenac sodium ophthalmic solution) 0.1%. A topical, twice- daily, non-steroidal anti-inflammatory solution, Xibrom is initially being developed for the treatment of ocular inflammation, eye pain and photophobia following cataract surgery. As previously announced, ISTA submitted the NDA for Xibrom in May 2004.

Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA stated, "This is an important step in the FDA's review of Xibrom, and we look forward to working closely with the agency. Pending the FDA's final review and approval, Xibrom could become our third product to enter the market, further establishing our key position in the ophthalmology sector."

About Xibrom
Xibrom (bromfenac sodium ophthalmic solution) 0.1% is a topical non- steroidal anti-inflammatory compound for the treatment of ocular inflammation, eye pain and photophobia following cataract surgery. Senju Pharmaceuticals Co. Ltd. has marketed this product in Japan since 2000. 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.

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 vitreous hemorrhage, diabetic retinopathy, hyphema, glaucoma, ocular pain and inflammation. ISTA is currently preparing to launch its first two products approved by the FDA, which are Vitrase for use as a spreading agent, and Istalol, for the treatment of glaucoma. Building on this pipeline, ISTA's goal is to continue its growth as a specialty pharmaceutical company by developing or acquiring complementary products, either already marketed or in late-stage development.

sodium ophthalmic solution) 0.1%. A topical, twice- daily, non-steroidal anti-inflammatory solution, Xibrom is initially being developed for the treatment of ocular inflammation, eye pain and photophobia following cataract surgery. As previously announced, ISTA submitted the NDA for Xibrom in May 2004.

Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA stated, "This is an important step in the FDA's review of Xibrom, and we look forward to working closely with the agency. Pending the FDA's final review and approval, Xibrom could become our third product to enter the market, further establishing our key position in the ophthalmology sector."

About Xibrom
Xibrom (bromfenac sodium ophthalmic solution) 0.1% is a topical non- steroidal anti-inflammatory compound for the treatment of ocular inflammation, eye pain and photophobia following cataract surgery. Senju Pharmaceuticals Co. Ltd. has marketed this product in Japan since 2000. 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.

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 vitreous hemorrhage, diabetic retinopathy, hyphema, glaucoma, ocular pain and inflammation. ISTA is currently preparing to launch its first two products approved by the FDA, which are Vitrase for use as a spreading agent, and Istalol, for the treatment of glaucoma. Building on this pipeline, ISTA's goal is to continue its growth as a specialty pharmaceutical company by developing or acquiring complementary products, either already marketed or in late-stage development.

Posted: July 2004

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