FDA Approves New Treatment for Allergic Conjunctivitis

Cheryl A. Thompson

BETHESDA, MD 09 September 2009—Ista Pharmaceuticals Inc. on Tuesday announced that FDA approved the marketing of bepotastine besilate ophthalmic solution, or Bepreve.

The antihistamine-containing product, the company said, is indicated for the treatment of ocular itching associated with allergic conjunctivitis in patients ages 2 years or older.

According to the product's FDA-approved labeling (PDF), the dosage is one drop of the ophthalmic solution in the affected eye or eyes twice a day. Patients wearing contact lenses should remove them before instilling the ophthalmic solution, which contains the preservative benzalkonium chloride.

The labeling states that the most commonly reported adverse event during the clinical trials was a "mild taste" after instillation of the ophthalmic solution. This occurred in about one fourth of the trials' participants.

According to the labeling, the efficacy of the ophthalmic solution in patients younger than age 10 was established by extrapolating the data for patients ages 10 years or older.

Ista said it expects to make Bepreve available in the United States in the fourth quarter of 2009.

Bepreve will be marketed in plastic squeeze bottles containing 10 mL of 1.5% bepotastine besilate ophthalmic solution.