FDA deals ISTA a blow
ISTA Pharmaceuticals has received a not approvable letter from the FDA relating to its New Drug Application (NDA) for T-Pred (prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension).
ISTA Pharmaceuticals has received a not approvable letter from the FDA relating to its New Drug Application (NDA) for T-Pred (prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension).
T-Pred is a topical steroid developed for the treatment of inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial ocular infections or a risk of bacterial infection exists.
A multicentre, randomized, double-blind study was conducted to determine bioequivalence of prednisolone concentrations between T-Pred and PredForte (prednisolone acetate 1.0%). ISTA believes that the study achieved or exceeded the goal, both in the intent-to-treat and the per-protocol patient populations. Furthermore, the company also believes that the study shows T-Pred to have antimicrobial activity equivalent to other combination products approved for this indication.
However, FDA assessment of the clinical data did not show sufficient equivalence between the prednisolone component in T-Pred and PredForte. ISTA disagrees with the findings and plans to request a meeting with the FDA as soon as possible to discuss the matter.
