ISTA Files IND to Begin Studies for Tobramycin, Prednisolone Acetate

ISTA Pharmaceuticals has filed an investigational new drug application with the 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.

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 million, with total prescriptions of 8.6 million.