ISTA Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for its eye drop treatment Bepreve (bepotastine besilate ophthalmic solution).
The twice-daily prescription eye drop treatment has been approved at 1.5% for ocular itching associated with allergic conjunctivitis in patients two years of age or older, the company said.
ISTA president and CEO Vincent Anido Jr said that Bepreve offers a new, safe and effective way to treat the itching caused by ocular allergies.
“Because of the timing of this approval and the strength of our underlying business, we will accelerate all of the launch activities immediately, including the scale-up of the sales force,” Anido said.
Two Phase III double-masked, placebo-controlled, conjunctival allergen challenge studies demonstrated Bepreve significantly reduced ocular itching, ISTA said.