ios during all time points measured. Although T-Pred's prednisolone concentrations in this study were similar to those of the reference product, bioequivalence was not demonstrated. ISTA believes differences in the prednisolone reference product, which included a higher drug concentration in the formulation and a recent change in the reference product commercial product delivery dose, may have contributed to the variations in study results between the two products.
ISTA is discussing the study results with the FDA to determine the best path forward for T-Pred. The Company is working with the FDA to determine the appropriate clinical study or studies to perform in lieu of an additional prednisolone bioequivalence study, although no further clinical studies are planned before 2010.
About ISTA Pharmaceuticals
ISTA Pharmaceuticals is the fourth largest branded ophthalmic pharmaceutical business in the U.S. ISTA's three marketed products plus its product candidates include therapies for inflammation, ocular pain, glaucoma, allergy, and dry eye. The Company is developing a strong product pipeline to fuel future growth and market share, thereby continuing its growth to become the leading niche ophthalmic pharmaceutical company in the U.S. For additional information regarding ISTA, please visit ISTA Pharmaceuticals' website athttp://www.istavision.com.
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements. Without limiting the foregoing, but by way of example, statements contained in this press release related to the outcome of ISTA's current or future discussions with the FDA and the potential initiation of further T-Pred clinical studies in 2010 are forward-looking statements. Except as required by law, ISTA disclaims
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