(Adds study findings, additional company comment; updates
By Lisa Richwine
WASHINGTON Dec 3 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
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
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,
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,"
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)