Eye Disorders/Infections (Pediatric)
May 25, 2009
Ista issued positive results from three phase III trials of Bepreve for the treatment of allergic conjunctivitis. The first two studies were 7-week, masked, randomized, placebo-controlled conjunctival allergen challenge (CAC) clinical studies and enrolled a total of 157 subjects who received placebo or Bepreve 1.5% in both eyes. The studies showed Bepreve 1.5% dosed in both eyes was clinically effective in reducing ocular itching associated with allergic conjunctivitis for at least 8 hours after dosing. It was statistically superior to placebo in reducing ocular itching at CAC tests conducted 15 minutes, 8 hours, and 16 hours after dosing (P<0.0001). The third study was a multi-center, double-masked, placebo-controlled design enrolled 86 subjects. The subjects were randomized to receive either Bepreve 1.5% or placebo in both eyes in three CAC tests spaced two weeks apart. The results showed Bepreve 1.5% was statistically superior to placebo for at least 8 hours after ophthalmic dosing for reducing CAC-induced tearing.