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ISTA files NDA for antibiotic/corticosteroid combo
ISTA Pharmaceuticals filed a New Drug Application for its investigational tobramycin and prednisolone acetate in a fixed combination (T-Pred). The company hopes the drug receives approval as a treatment for inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial ocular infections or a risk of bacterial infections exists.
ISTA Pharmaceuticals filed a New Drug Application (NDA) for its investigational tobramycin and prednisolone acetate in a fixed combination (T-Pred). The company hopes the drug receives approval as a treatment for inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial ocular infections or a risk of bacterial infections exists.
The multicenter, randomized, double-masked U.S. phase III trial successfully demonstrated bioequivalence of prednisolone between ISTA's combination product and prednisolone acetate 1%. ISTA's combination product achieved or exceeded its goal both in the intent-to-treat and the pre-protocol patient populations.
"Pending acceptance and timely approval of our T-Pred NDA submission, we anticipate a potential launch of this product in mid-2007," said Vicente Anido, PhD, president and chief executive officer of ISTA Pharmaceuticals.
