UPDATE 2-US panel supports Allergan drug for longer lashes

(Adds comments from meeting, quotes, byline)

By Susan Heavey

ROCKVILLE, Md. Dec 5 (Reuters) - A prescription eye drug originally used to treat glaucoma is also safe and effective for adults who want the longer, thicker eyelashes, a U.S. advisory panel said on Friday.

The drug, by Botox maker Allergan Inc (AGN.N), was first studied to help relieve eye pressure when patients began reporting an unusual side effect: eyelash growth. The company is now seeking U.S. approval to market the new use under the brand name Latisse.

At a Food and Drug Administration panel meeting, outside advisers overwhelmingly said years of data gathered from the glaucoma use under the name Lumigan showed the drops helped boost lashes.

"I have absolutely no reason to question the efficacy," said panelist M. Roy Wilson, an ophthalmologist from the University of Colorado. Wilson and others also cited the lack of serious side effects with the drug in clinical trials.

But many panelists raised concerns about long-term use and the lack of data on blacks and other minorities. The drug must be applied continuously or lashes will shrink to original size after a few months, according to the company.

Panelists also questioned whether teenagers and other patients might use it inappropriately, although the drug would only be available by prescription. There was no data on patients younger than 18.

"It's those teenagers substituting it for mascara that would concern me," said ophthalmologist Marijean Miller, a panelist from Children's National Medical Center in Washington.

The FDA should require Allergan to collect more data after the drug hits the market, the majority of panelists said. The agency usually follows panel recommendations.

If approved, Allergan's sales force could promote Latisse alongside the company's blockbuster anti-wrinkle injection Botox and Juvederm, which fills lines around the mouth.

The Latisse version will package the drops with a special applicator to apply the drops on the edge of the eyelid rather than into the eye as with its glaucoma use. Eyelash sales of the drug, known generically as bimatoprost, could fetch more than $500 million in global sales per year, Allergan has said. Its total revenues were $3.9 billion in 2007.

Still, analysts noted cosmetic drugs face an uphill battle amid a growing economic recession.

Wachovia analyst Larry Biegelsen said Latisse would provide a significant commercial opportunity for Allergan.

"However, we think the initial uptake will be muted due to the economic situation," he said in a research note that forecast Latisse sales of $30 million in 2009 and $310 million in 2012.

Consumer advocates voiced another reason to be skeptical: the drug may cause light-colored eyes to gradually turn brown if too much gets into the eye. It can also cause eye irritation and darkening of the skin around the eye.

"Changing eye color is an adverse reaction that is acceptable to someone trying to prevent blindness from glaucoma, but is probably not acceptable to someone using the product to improve their eyelashes," said Brandel France deBravo, a spokeswoman for the National Research Center for Women and Families.

But company officials said most patients did not notice the color change and most side effects were completely reversible when patients stopped using the drops. In the case of the darker skin, "some of the subjects ... actually appreciated it because it looked like an eyeliner," said Frederick Beddingfield, head of Allergan's dermatology research unit.

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, an FDA staff review said.

Unapproved eyelash products with drug ingredients have recently appeared on the market, Allergan said in a statement after the meeting.

"Latisse will offer consumers an FDA-approved product which has been extensively studied ... and is regulated as a prescription product," Scott Whitcup, Allergan's executive vice president of research and development, said. (Additional reporting by Lisa Richwine; editing by Gary Hill and Andre Grenon)