Allergan Eyedrops Closer to Market

Allergan Inc. said Tuesday that it expects its prescription eyedrops for treating dry-eye disease to receive regulatory clearance once the U.S. Food and Drug Administration and the Irvine company resolve final details.

Called Restasis, Allergan’s product is the first cyclosporine eyedrop designed for human use. If approved, it also will be the first prescription drug marketed for the treatment of dry-eye disease, a condition that so far has been managed with over-the-counter eyedrops.

Allergan said the FDA issued an “approvable” letter, meaning the agency wants to approve a drug but will do so only after the final details of an application--such as manufacturing logistics or wording on a drug label--are completed to the FDA’s satisfaction.

The action was unexpected because it moves the FDA closer to overruling a medical advisory committee, which recommended last month that the agency reject the drug. The FDA usually follows the advice of its expert panels but is not required to do so.

The advisory panel said the company did not provide enough data to show that Restasis worked significantly better than over-the-counter eyedrops to ease the symptoms of dry-eye disease.

Symptoms of dry-eye disease, which affects as many as three million people in the U.S., include irritation and redness of the eyes. The disease tends to afflict post-menopausal women.

Though Restasis would be the first use in humans of cyclosporine eyedrops, Schering-Plough Corp. markets a cyclosporine treatment called Optimmune for dogs that suffer from dry-eye disease.

Cyclosporine is also administered orally or by injection to help prevent the rejection of donor organs in transplant patients, and to treat severe cases of rheumatoid arthritis and psoriasis.

Allergan announced the approvable letter after the close of stock trading Tuesday and didn’t provide any details of requirements for approval of Restasis.

Shares in the eye product company edged up 6 cents to $101.81.