General Information

Bepreve (bepotastine besilate ophthalmic solution) is a topically active, direct H1 receptor antagonist and an inhibitor of the release of histamine from mast cells.

Bepreve is specifically indicated for for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.

Bepreve is supplied as a solution designed for topical administration. The recommended dose of the drug is one drop into the affected eye(s) twice a day.

Mechanism of Action

Bepreve (bepotastine besilate ophthalmic solution) is a topically active, direct H1 receptor antagonist and an inhibitor of the release of histamine from mast cells.

Side Effects

Adverse events associated with the use of Bepreve may include, but are not limited to, the following:

• mild taste following instillation
• eye irritation
• headache
• nasopharyngitis

Clinical Trial Results

The FDA approval of Bepreve was based on two conjunctival allergen challenge (CAC) studies in 237 patients. Bepreve 1.5% was more effective than placebo for relieving ocular itching induced by an ocular allergen challenge, both at CAC 15 minutes post-dosing and a CAC 8 hours post dosing of Bepreve. The safety of Bepreve was evaluated in a randomized clinical study of 861 subjects over a period of 6 weeks. It was determined to be safe and well tolerated.