FDA panel rejects Allergan's Restasis; no significance versus placebo

The US Food and Drug Administration's Dermatologic and Ophthalmic DrugsAdvisory Committee has voted against recommending approval of Allergan's Restasis (cyclosporine ophthalmic emulsion 0.05%) for the treatment of keratoconjunctivitis sicca, a moderate-to-severe chronic dry eye disease. Shares in the company dropped just over 16% on the day of the announcement (July 21) to close at $92.56, on volume of more than 2.8 million.

The panel concluded that Restasis was not significantly better than placebo in most primary endpoints of the study. However, Allergan says that it "has great confidence in its novel therapeutic treatment and is reviewing the Committee's recommendations." The FDA, which normally follows the recommendations of its advisory panel, has until the end of August to either accept or reject the marketing application.

This chronic dry eye disease affects up to 3 million people in the USA alone, says the company, which adds that it believes new treatment options are required. It is associated with tear deficiency and may result in inflammation of the epithelial surface of the eye, corneal scarring and even loss of sight. Keratoconjunctivitis sicca, which some researchers suggest represents a chronic wound-healing response to a dry and inflamed eye, is currently treated with over-the-counter artificial tear products. If approved, Restasis will be the first prescription medication available for this condition.