ISTA PHARMACEUTICALS FILES NDA FOR T-PRED
ISTA Pharmaceuticals has filed a new drug application (NDA) with the FDA for its investigational ophthalmic product, T-Pred, containing tobramycin and prednisolone acetate in a fixed combination. The company is seeking approval for T-Pred as a treatment for ISTA completed a Phase III study of its combination product. The multicenter, randomized, double-masked inflammatory ocular conditions for which a corticosteroid is indicated, and where bacterial ocular infections or a risk of bacterial infections exists.
In 2005, trial successfully achieved its primary endpoint, demonstrating bioequivalence of prednisolone between ISTA's combination product (prednisolone acetate 1 percent and tobramycin 0.3 percent) and prednisolone acetate 1 percent.