UPDATE 2-Allergan drug lengthens eyelashes -US FDA staff

Wed Dec 3, 2008 2:58pm EST

(Adds study findings, additional company comment; updates stock price)

By Lisa Richwine

WASHINGTON Dec 3 (Reuters) - A drug from Botox maker Allergan Inc (AGN.N) increased the length, thickness and darkness of eyelashes in a company study, U.S. drug reviewers said in a report released on Wednesday.

The analysis was prepared for a Food and Drug Administration advisory panel that meets Friday to evaluate the proposed cosmetic use of the drug, bimatoprost, now sold for treating glaucoma.

The panel of outside experts will consider if bimatoprost offers enough benefit to outweigh the risks of its use on the eyelashes, the FDA staff report said.

Four out of 137 patients who used the drug, which was applied daily along the upper eyelids, dropped out of Allergan's study because of mild or moderate eczema, dry eye, eye inflammation or dermatitis, FDA staff said.

Allergan, in a separate summary, said problems reported by users "occurred at a low frequency and were largely mild in severity, cosmetic in nature, and reversible." They included eye itchiness reported by 3.6 percent of patients, and eye irritation reported by about 2 percent of patients.

"The overall benefit-risk assessment of bimatoprost for eyelash growth is favorable due to the fact that risks are minimal and the aesthetic benefits are well-demonstrated and meaningful," the company said.

Allergan estimates global peak sales for the eyelash drug could top $500 million per year. The proposed brand name is Latisse, and it would be sold by prescription.

Approval would give Allergan's sales force the opportunity to promote it alongside the company's blockbuster anti-wrinkle injection Botox and Juvederm, which fills wrinkles around the mouth. Allergan's total revenues were $3.9 billion in 2007.

The FDA will make the final decision on whether to approve the eyelash treatment but usually follows panel recommendations.

The eyelash drug is a formulation of Allergan's glaucoma treatment Lumigan, which is given as drops placed directly in the eye to combat excessive pressure within the eye that can cause vision loss. Eyelash growth was reported as a side effect in the glaucoma studies.

Allergan evaluated the eyelash use in a study of 137 patients who were given the drug and 141 others who got a placebo. Researchers rated the appearance of eyelashes on a four-point scale ranging from "minimal" to "very marked."

After 16 weeks, 78 percent of patients who got the drug had at least a one-point improvement, compared with 18 percent of placebo patients, the FDA staff review said.

Allergan said the safety of bimatoprost was well-established after seven years on the market as a glaucoma treatment. The company proposed a plan to inform patients and prescribers about the risks of the eyelash use, and said the drug should only be used on the upper eyelid.

The drug may reduce eye pressure if it gets into the eye, but changes seen in the eyelash study were not meaningful, Allergan said.

The company advised against trying the drug on other body parts such as the eyebrows or scalp. The formulation is not likely to penetrate the scalp enough to deliver sufficient drug to the hair follicles, "resulting in poor or no efficacy," Allergan said.

Shares of Allergan were up 1.9 percent to $35.47 in afternoon trading on the New York Stock Exchange. (Reporting by Lisa Richwine; Editing by Gerald E. McCormick and Tim Dobbyn)