FDAnews Drug Daily Bulletin

Ista Challenging T-Pred Not Approvable Letter

May 8, 2007

The FDA issued a not approvable letter for Ista Pharmaceutical’s eye treatment T-Pred because a clinical trial did not meet the expected endpoints, the agency said. However, the company said it disagreed with the agency’s decision and would request a meeting with the FDA.

T-Pred is a topical steroid to treat inflammatory eye conditions with a risk of bacterial infections, the company said in a statement. A clinical study of the drug met the endpoints that Ista and the FDA had agreed to in a protocol assessment, company president and CEO Vincente Anido said.

However, the FDA said data from the clinical trial was not sufficient to approve the drug. The company plans to request a meeting with the FDA “as soon as possible” to work with the agency and bring the drug to patients, Anido added.

Ista completed a Phase III clinical study in 2005 meant to compare the bioequivalence of prednisolone concentrations between T-Pred and competing product, Allergan’s Pred Forte. The company says its product achieved or exceeded the goal of the study in both protocol and intent-to-treat patient populations. In addition, T-Pred showed equal antimicrobial activity to other combination products approved to treat the indication, according to Ista.

But the FDA said the study did not show sufficient equivalence in the prednisolone concentrations between T-Pred and Pred Forte. The data also did not show equivalence in the kill time between the tobramycin components in T-Pred and Tobrex, although T-Pred did show equivalent kill time compared with two other eye products, the FDA said.