ISTA files NDA with FDA for combination product

Irvine, CA-ISTA Pharmaceuticals Inc. announced it 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 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 phase III trial successfully demonstrated bioequivalence of prednisolone between ISTA Pharmaceuticals' combination product and prednisolone acetate 1%. ISTA Pharmaceuticals' combination product achieved or exceeded its goal both in the intent-to-treat and the pre-protocol patient populations, the company said in a prepared statement.

"We are pleased with the successful and timely achievement of this regulatory milestone in the development of T-Pred," said Vicente Anido, PhD, president and chief executive officer of ISTA Pharmaceuticals.

If approved, ISTA Pharmaceuticals' combination drug will compete in the antibiotic steroid segment of the U.S. topical ophthalmic anti-inflammatory market.