From rxpgnews.com

Ophthalmology
Tobramycin and Prednisolone Combination for Inflammatory Ocular Conditions
By ISTA Pharmaceuticals, Inc.
Apr 28, 2005, 10:25

ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA - News) announced today that the Company has filed an Investigational New Drug (IND) application with the U.S. Food & Drug Administration (FDA) to initiate a U.S. Phase III study of a new combination ophthalmic product containing tobramycin and prednisolone acetate for the treatment of steroid-responsive inflammatory ocular conditions where risk of bacterial infection exists.

Vicente Anido, Jr., Ph.D., ISTA's Chief Executive Officer, stated, "This new combination ophthalmic product was developed by ISTA and is a fixed combination of tobramycin and prednisolone acetate in a proprietary formulation that we believe will provide greater patient comfort in inflamed eyes. Both of the active ingredients in the product are approved drugs on their own. Based upon the timely commencement of the Phase III clinical trials this year, we would expect to submit a New Drug Application (NDA) to the FDA during the first half of 2006."

The 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 estimates of sales and 2004 prescription data from IMS Health, 2004 sales in the U.S. topical ophthalmic anti-inflammatory market were approximately $400 MM, with total prescriptions of 8.6 million.

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