FDA Approves Bepotastine Ophthalmic Solution for Treating "Allergy Eyes"

Yael Waknine

September 09, 2009

September 9, 2009 — The FDA has approved bepotastine besilate 1.5% ophthalmic solution (Bepreve, ISTA Pharmaceuticals, Inc) for the twice-daily treatment of ocular itching associated with allergic conjunctivitis in patients aged 2 years and older.

Approval of the histamine H1 receptor antagonist was based primarily on data from 2 phase 3 double-blind, conjunctival allergen challenge studies (n = 237) showing that bepotastine significantly decreased ocular itching relative to use of the vehicle alone at 15 minutes and 8 hours postdose.

Adverse events reported in 2% to 5% of treated patients included eye irritation, headache, and nasopharyngitis.

"Patients who experience ocular itching due to allergies want comfortable, quick and long-lasting relief for their eyes. Bepreve is the first truly new treatment for allergic conjunctivitis approved in several years.... I am excited patients will have this new treatment option," noted Gregg J. Berdy, MD, assistant professor of clinical ophthalmology, Washington University School of Medicine, St. Louis, Missouri, in a company news release.

To minimize the risk for contamination, patients should be advised to avoid touching the eyelids or surrounding areas with the dropper tip of the medication bottle.

Because soft contact lenses can absorb benzalkonium chloride (used as a preservative), they should be removed before instillation of bepotastine drops. Lenses may be reinserted 10 minutes after dosing.

Oral bepotastine previously was approved in Japan for the systemic treatment of allergic rhinitis and urticaria/pruritis.