ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced preliminary results from two recently completed studies on its investigational ophthalmic product, T-Pred(TM) (prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension). The Company is developing T-Pred as a treatment for inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial ocular infection exists, or there is a risk of bacterial infection.
In the first study, ISTA evaluated the antimicrobial equivalence between T-Pred and a tobramycin-containing reference product. In vitro tests were conducted to compare the kill rate of T-Pred with the kill rate of the reference product for each of the micro-organisms listed in the reference product's package insert as well as additional micro-organisms specified by the Food and Drug Administration (FDA). ISTA successfully demonstrated the antimicrobial bioequivalence of T-Pred to the reference product in each of the 26 required tests.