Bepotastine besilate ophthalmic solution 1.5% clears the hurdle for allergic ocular itching

The FDA Dermatologic and Ophthalmic Drugs Advisory Committee has recommended the approval of bepotastine besilate ophthalmic solution 1.5% (Bepreve, ISTA Pharmaceuticals) for treating ocular itching associated with allergic conjunctivitis.

Key Points

Irvine, CA-The FDA Dermatologic and Ophthalmic Drugs Advisory Committee has recommended the approval of bepotastine besilate ophthalmic solution 1.5% (Bepreve, ISTA Pharmaceuticals) for treating ocular itching associated with allergic conjunctivitis.

The FDA still is required to approve the application and has set a date of Sept. 12 to take further action on the drug.

Bepotastine besilate is an eye-drop treatment that acts as a non-sedating, highly selective antagonist of the histamine receptor. It has been approved in Japan since 2000 to treat allergic rhinitis and urticaria/pruritus.