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| |  FDA Approves Optivar (Azelastine) Ophthalmic Solution For Allergic Conjunctivitis In Patients Three Years And Older TEWKSBURY, MA -- June 19, 2000 -- Muro Pharmaceutical, Inc., an ASTA Medica Company, announced that the US Food and Drug Administration (FDA) has approved Optivar™ (Azelastine HCL Ophthalmic Solution) 0.05% for the treatment of itching of the eye associated with allergic conjunctivitis in adults and children three years of age and older. The recommended dosage regimen for Optivar is one drop instilled into each affected eye twice daily. Azelastine hydrochloride is a relatively selective histamine H1 antagonist/mast cell stabilizer and an inhibitor of the release of histamine and other mediators from cells involved in the allergic response. The unique characteristics of Optivar allow this product to have a rapid onset of action (within three minutes) and a long duration of effect (approximately eight hours) with a twice daily dosing. Optivar has been proven to be safe in patients three years of age and older. The most commonly reported adverse events in controlled studies, where patients were treated for up to 56 days, were transient eye burning/stinging, headaches, and bitter taste. The occurrence of these events was generally mild. In a conjunctival antigen challenge study, Optivar was more effective than its vehicle in preventing itching associated with allergic conjunctivitis. According to the study's principal investigator, Mitchell H. Friedlaender, M.D., Scripps Clinic, La Jolla, CA.
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