Shares of Irvine-based Ista Pharmaceuticals Inc. fell sharply Friday after the company said its T-Pred topical steroid eye treatment received a “not approvable” letter from the Food and Drug Administration.
Ista’s shares declined nearly 30% to $6.80 on the news.
The FDA didn’t find sufficient clinical information to approve T-Pred, which is being developed to treat inflammatory eye diseases that require corticosteroid treatment and risk bacterial infection, Ista said in a statement.
“While we are disappointed by the FDA’s decision, Ista is committed to bringing T-Pred to ophthalmologists and patients,” said Vincente Anido Jr., Ista’s chief executive. “We believe our clinical study met the endpoints that Ista and the FDA agreed to in the special protocol assessment.”
Ista also said it’s requesting a meeting with the FDA as soon as possible to decide on actions the company needs to receive marketing approval for T-Pred.
