ISTA Pharmaceuticals’ Bepreve™ Receives FDA Approval For Ocular Itching Associated With Allergic Conjunctivitis
September 17, 2009
ISTA Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration has approved Bepreve™(bepotastine besilate ophthalmic solution) 1.5% as a twice a day prescription eye drop treatment for ocular itching associated with allergic conjunctivitis in patients two years of age and older.
ISTA had conducted two Phase 3 double-masked, placebo-controlled, conjunctival allergen challenge (CAC) studies demonstrated that Bepreve significantly reduced ocular itching. The studies demonstrated Bepreve’s rapid onset of action in providing relief to people with ocular itching associated with allergic conjunctivitis as well.
Bepreve is a non-sedating, highly selective antagonist of the histamine (H1) receptor. It has a stabilizing effect on mast cells and suppresses the migration of eosinophils into inflamed tissues. Bepreve is expected to be available for physicians and patients during the fourth quarter of this year.
Read the release.
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