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, we believe T-Pred will offer patients a powerful new treatment combining fast anti-inflammatory relief with excellent anti-bacterial coverage," Dr. Anido added. "Pending acceptance and timely approval of our T-Pred NDA submission, we anticipate a potential launch of this product in mid-2007."
If approved, ISTA Pharmaceuticals' combination drug will compete in the antibiotic steroid segment of the U.S. topical ophthalmic anti-inflammatory market.