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Allergan Restasis approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Allergan's Restasis (cyclosporine ophthalmic emulsion 0.5%) clears FDA Dec. 23 for treatment of keratoconjunctivitis sicca (chronic dry eyes) after a protracted review. The original Feb. 24, 1999 NDA was granted priority status, but review was complicated by a unanimous advisory committee vote against approval in July 1999 and three "approvable" letters. In the NDA's four studies comparing Restasis to vehicle in 1,200 patients, a statistically significant increase in Schirmer wetting at six months was seen in 15% of Restasis patients. The agent will be available in early Apri

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