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New Drug Application Filed for Ophthalmic Product Containing Tobramycin, Prednisolone Acetate

IRVINE, Calif., July 6 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (NASDAQ:ISTA) announced today that the Company has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for its investigational ophthalmic product, T-Pred(TM), containing tobramycin and prednisolone acetate in a fixed combination. The Company is seeking approval for T-Pred as a treatment for inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial ocular infections or a risk of bacterial infections exists.

According to 2005 IMS Health data, prednisolone acetate is the most prescribed ophthalmic steroid, and tobramycin is the most prescribed aminoglycocide antibiotic solution by ophthalmologists in the United States.

"We are pleased with the successful and timely achievement of this regulatory milestone in the development of T-Pred. This product candidate represents ISTA's commitment to bringing novel or uniquely improved products to ophthalmologists and their patients. If approved, we believe T-Pred will offer patients a powerful new treatment combining fast anti-inflammatory relief with excellent anti-bacterial coverage," stated Vicente Anido, Ph.D., President and Chief Executive Officer of ISTA Pharmaceuticals. "Pending acceptance and timely approval of our T-Pred(TM) NDA submission, we anticipate a potential launch of this product in mid-2007."

About Tobramycin and Prednisolone Acetate
In the fourth quarter of 2005, ISTA completed its U.S. phase 3 study of its combination product containing tobramycin and prednisolone acetate for the treatment of inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial ocular infections or a risk of bacterial infections exists. The multi-center, randomized, double-masked U.S. Phase III trial successfully achieved its primary endpoint, demonstrating bioequivalence of prednisolone between ISTA's combination product (prednisolone acetate 1.0% and tobramycin 0.3%) and prednisolone acetate 1.0%. To demonstrate the two products were bioequivalent, the ratio of the concentrations of prednisolone needed to establish bioequivalence must fall between 80% and 125%, with 90% confidence. ISTA's combination product achieved or exceeded its goal both in the intent-to-treat and the per-protocol patient populations.

ISTA expects its tobramycin and prednisolone acetate combination product, if approved, will compete in the antibiotic steroid segment of the U.S. topical ophthalmic anti-inflammatory market. Based upon management's estimates and IMS Health 2005 prescription data, ISTA estimates 2005 sales in the U.S. topical ophthalmic anti-inflammatory market exceeded $400 million, with total prescriptions of approximately 8.8 million.

Source: ISTA Pharmaceuticals

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