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FDA Approves Bepotastine Besilate Solution for Ocular Itching Associated With Allergies
NEW YORK -- September 9, 2009 -- The US Food and Drug Administration (FDA) has approved bepotastine besilate ophthalmic solution (Bepreve) 1.5% as a twice-daily prescription eye drop treatment for ocular itching associated with allergic conjunctivitis in patients aged 2 years and older.
The approval is based on 2 phase 3, double-masked, placebo-controlled, conjunctival allergen challenge (CAC) studies which demonstrated that bepotastine besilate solution significantly reduced ocular itching.
In addition, the studies achieved statistical significance and demonstrated bepotastine besilate ophthalmic solution's rapid onset of action in providing relief to persons with ocular itching associated with allergic conjunctivitis.
"Patients who experience ocular itching due to allergies want comfortable, quick and long-lasting relief for their eyes," said Gregg J. Berdy, MD, Clinical Ophthalmology, Washington University School of Medicine, St. Louis, Missouri. "[Bepotastine besilate solution] is the first truly new treatment for allergic conjunctivitis approved in several years…" commented Gregg J. Berdy, M.D., Assistant Professor of Clinical Ophthalmology, Washington University School of Medicine.
The most common reported adverse reaction occurring in approximately 25% of patients was a mild taste following instillation. Other adverse reactions occurring in 2% to 5% of patients were eye irritation, headache, and nasopharyngitis.
SOURCE: ISTA Pharmaceuticals
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