Home » Drug Information » FDA Approved Drugs » 2009
Medical Areas: Immunology | Ophthalmology | Family Medicine | Infections and Infectious Diseases
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Bepreve (bepotastine besilate ophthalmic solution)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Ista Pharmaceuticals
Approval Status: Approved September 2009
Treatment Area: itching associated with allergic conjunctivitis
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.
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.
Adverse events associated with the use of Bepreve may include, but are not limited to, the following:
- mild taste following instillation
- eye irritation
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.
For additional information regarding Bepreve or itching associated with allergic conjunctivitis, please visit the Bepreve web page.