The FDA has approved Bepreve (bepotastine besilate ophthalmic solution 1.5%, ISTA Pharmaceuticals) as a twice-daily prescription eye drop treatment for ocular itching associated with allergic conjunctivitis in patients two years of age and older. Bepreve is a non-sedating, highly selective antagonist of the histamine (H1) receptor. It has a stabilizing effect on mast cells, and suppresses the migration of eosinophils into inflamed tissues, the company says. Bepotastine is currently used in Japan as a systemic drug for allergic rhinitis and urticaria/pruritus.
The FDA also approved Zirgan (ganciclovir ophthalmic gel 0.15%, Sirion Therapeutics) as a treatment for acute herpetic keratitis (dendritic ulcers). This is the first topical ophthalmic therapy to target only viral-infected cells. The company expects Zirgan to be commercially available in early 2010. In Europe, topical ganciclovir has been the standard of care for treating herpetic ulcers for 10 years, the company says.