ISTA Pharmaceuticals, Inc. filed a New Drug Application (NDA) to the USFDA for its investigational ophthalmic product, T-Pred™, containing tobramycin and prednisolone acetate in a fixed combination.
T-Pred™ when approved will be a treatment for inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial ocular infections or a risk of bacterial infections exists.
Prednisolone acetate is the most prescribed ophthalmic steroid, and tobramycin is the most prescribed aminoglycocide antibiotic solution by ophthalmologists in the United States according to the 2005 IMS Health data.
Read more at 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," stated Vicente Anido, Ph.D., President and Chief Executive Officer of ISTA Pharmaceuticals.
"Pending acceptance and timely approval of our T-Pred™ NDA submission, we anticipate a potential launch of this product in mid-2007."
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