FDA approves bepotastine drops for ocular itching

September 16, 2009

The FDA has approved bepotastine besilate ophthalmic solution 1.5% (Bepreve, ISTA Pharmaceuticals) as a twice-daily prescription eye drop treatment for ocular itching associated with allergic conjunctivitis.

Irvine, CA

-The FDA has approved bepotastine besilate ophthalmic solution 1.5% (Bepreve, ISTA Pharmaceuticals) as a twice-daily prescription eye drop treatment for ocular itching associated with allergic conjunctivitis. It is approved for patients aged 2 or more years.

“[Bepotastine] offers a new, safe, and effective way to treat the itching caused by ocular allergies. We expect to have [the drop] available to ophthalmologists and patients in the United States in the fourth quarter of 2009,” said Vicente Anido Jr., PhD, president and chief executive officer of ISTA.

The company conducted multiple clinical studies, evaluating the safety, efficacy, onset, and duration of effect of the eye drops, according to a prepared statement. Two phase III double-masked, placebo-controlled, conjunctival allergen challenge studies demonstrated that bepotastine significantly reduced ocular itching. In addition, the studies achieved statistical significance and demonstrated that the drop worked quickly in providing relief to patients with ocular itching associated with allergic conjunctivitis, the company said.