ISTA Pharmaceuticals, Inc announced the Dermatologic and Ophthalmic Drugs Advisory Committee appointed by the US Food and Drug Administration (FDA) recommended the approval of Bepreve (bepotastine besilate ophthalmic solution) 1.5 per cent as an eye drop treatment for ocular itching associated with allergic conjunctivitis. The committee voted unanimously seven to zero in favour of approving Bepreve after reviewing comprehensive safety and efficacy data from ISTA's clinical programme.
"The committee's vote supports our belief that Bepreve provides a safe and effective treatment for ocular itching associated with allergic conjunctivitis. We will continue to work closely with the FDA as we approach the September 12th action date," stated Vicente Anido president and chief executive officer of ISTA Pharmaceuticals.
Although the FDA is not required to follow the committee's guidance, the agency usually considers the committee's recommendation when evaluating pending applications. The FDA has assigned a Prescription Drug User Fee Action Date of September 12, 2009.
Bepreve is a non-sedating, highly selective antagonist of the histamine (H1) receptor. It has a stabilizing effect on mast cells, and it suppresses the migration of eosinophils into inflamed tissues.
ISTA Pharma is an ophthalmic pharmaceutical company. ISTA's products and product candidates addressing the $5.1 billion U.S. prescription ophthalmic industry include therapies for inflammation, ocular pain, glaucoma, allergy, and dry eye.