The FDA has approved Bepreve (bepotastine besilate ophthalmic solution, from ISTA Pharmaceuticals), a histamine H1 receptor antagonist, for the treatment of itching associated with signs and symptoms of allergic conjunctivitis. This approval was based on results from two Phase 3 double-masked, placebo-controlled, conjunctival allergen challenge (CAC) studies that demonstrated Bepreve to have significantly reduced ocular itching. In addition, the studies achieved statistical significance and demonstrated Bepreve’s rapid onset of action in providing relief of ocular itching associated with allergic conjunctivitis.
Bepreve is expected to be made available in the fourth quarter of 2009.
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