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ISTA files NDA for tobramycin/prednisolone combination T-Pred for eye conditions
By E. Janene Geiss
Philadelphia, July 6 - ISTA Pharmaceuticals, Inc. said Thursday that the company has filed a New Drug Application with the Food and Drug Administration for its investigational ophthalmic product, T-Pred, containing tobramycin and prednisolone acetate in a fixed combination.
The company said it is seeking approval for T-Pred 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, according to a company news release.
According to 2005 IMS Health data, prednisolone acetate is the most prescribed ophthalmic steroid and tobramycin is the most prescribed aminoglycocide antibiotic solution by ophthalmologists in the United States.
The company said it anticipates a mid-2007 launch of the product if approved.
In the fourth quarter of 2005, ISTA completed its phase 3 study of its combination product containing tobramycin and prednisolone acetate for the treatment of inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial ocular infections or a risk of bacterial infections exists.
The multi-center, randomized, double-masked trial successfully achieved its primary endpoint, demonstrating bioequivalence of prednisolone between ISTA's combination product (prednisolone acetate 1.0% and tobramycin 0.3%) and prednisolone acetate 1.0%.
To demonstrate the two products were bioequivalent, the ratio of the concentrations of prednisolone needed to establish bioequivalence must fall between 80% and 125%, with 90% confidence.
ISTA's combination product achieved or exceeded its goal both in the intent-to-treat and the per-protocol patient populations, officials said.
ISTA is an Irvine, Calif., specialty pharmaceutical company focused on ophthalmic products.
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