ISTA ANNOUNCES POSITIVE RESULTS FOR TOBRAMYCIN AND PREDNISOLONE ACETATE COMBINATION PRODUCT

Ista Pharmaceuticals has announced positive results from a Phase III bioequivalence study of the company's proprietary investigational combination ophthalmic product containing tobramycin and prednisolone acetate for the treatment of steroid-responsive inflammatory ocular conditions where risk of bacterial infection exists.

The multicenter, randomized, double-masked trial successfully achieved its primary endpoint, demonstrating bioequivalence of prednisolone between the company's combination product (tobramycin 0.3 percent/prednisolone acetate 1 percent) and prednisolone acetate 1 percent. To demonstrate that the two products were bioequivalent, the ratio of the concentrations of prednisolone needed to establish bioequivalence must fall between 80 percent and 125 percent, with 90 percent confidence.