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FDA Rejects Treatment for Bacterial Eye Infections
"While we are disappointed by the FDA's decision, ISTA is committed to bringing T-Pred to ophthalmologists and patients. We believe our clinical study met the endpoints that ISTA and the FDA agreed to in the Special Protocol Assessment," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA Pharmaceuticals. "Nonetheless, the FDA did not find sufficient clinical information to merit approval. We plan to work closely with the Agency to resolve this issue in an efficient manner. We intend to request a meeting with the Agency to come to agreement on the actions ISTA must undertake to receive marketing approval for T-Pred."
In the fourth quarter of 2005, ISTA completed its U.S. Phase III clinical study of T-Pred. The study was designed as a multi-center, randomized, double-blind study to determine the bioequivalence of prednisolone concentrations between T-Pred (prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension) and PredForte(R) (prednisolone acetate 1.0%). ISTA believes its study demonstrated T-Pred achieved or exceeded this goal both in the intent-to-treat and the per-protocol patient populations. In addition, the Company believes its studies showed T-Pred to have antimicrobial activity equivalent to other combination products approved for this indication.
The FDA assessed the Company's clinical data as not showing sufficient equivalence between the prednisolone component in T-Pred and PredForte at least at one of the time points measured nor equivalence in the kill time between the tobramycin components in T-Pred and Tobrex(R), although it showed equivalence versus Zylet(R) and Tobradex(R). ISTA does not agree with this assessment and plans to request a meeting with the FDA as quickly as possible.
Source: ISTA Pharmaceuticals