The FDA Ophthalmic Drugs Subcommittee advisory panel unanimously recommended not to approve Allergan's Restasis for dry eye after concluding that clinical trials involving almost 900 patients, did not show efficacy. 

Allergan supplied phase 2 and phase 3 study data in its PMA application.  Wiley A. Chambers, MD, Deputy Director of Anti-inflammatory, Analgesic and Ophthalmic Drug Products of the FDA chaired the meeting, and by the end of the day the panel had decided that the trials, involving 877 dry eye patients, showed no significant difference between cyclosporine treatment and placebo.  The studies looked at both dry eye symptoms and signs, including corneal staining, and Schirmer testing.