Allergan Restasis
Executive Summary
Company receives "approvable" letter for .05% cyclosporine ophthalmic emulsion. The NDA is being reviewed for treatment of moderate to severe keratoconjunctivitis sicca. FDA's Dermatologic & Ophthalmic Drugs Advisory Committee voted against approval July 21, but said that completed extension phases of two U.S. Phase III trials could provide additional evidence of a clinical effect (1"The Pink Sheet" July 26, p. 5)