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T-Pred filed for regulatory approval
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IRVINE, Calif. — A combination drug of tobramycin and prednisolone has been filed for regulatory approval for the treatment of inflammatory ocular conditions, according to the drug’s marketer.
ISTA Pharmaceuticals said T-Pred contains tobramycin and prednisolone acetate in a fixed combination. It will be marketed as an anti-inflammatory drug for conditions in which a corticosteroid is indicated and where bacterial ocular infections or a risk of bacterial infections exist. The New Drug Application is based on results from a phase 3 trial concluded late in 2005. The trial met its endpoint of demonstrating bioequivalence of prednisolone between the combination product and prednisolone alone.
ISTA officials said they expect to launch T-Pred some time in mid-2007.