UPDATE 2-US panel supports Allergan drug for longer lashes

Fri Dec 5, 2008 6:32pm EST
 
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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.  Continued...

 

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