Irvine-based Ista Pharmaceuticals Inc.’s proposed eye allergy drops didn’t cause serious safety problems in clinical trials, Food and Drug Adminisration reviewers said in documents released Wednesday.
FDA reviewers said in that in one study, 25% of patients treated with Ista’s proposed drug, which is called Bepreve, reported a taste-related side effect such as a bitter taste or aftertaste.
A FDA advisory panel is due to meet Friday to consider if Bepreve has shown adequate safety and effectiveness.
Ista acquired the rights to Bepreve in 2006 from Japan’s Senju Pharmaceutical Co. Ltd. The company also has rights to develop a formulation of Bepreve for nasal allergies.
