FDA OK's Lumigan for longer eyelashes

WASHINGTON, D.C.; December 5, 2008

Allergan, which makes Botox anti-wrinkle injections, has asked the Food and Drug Administration to approve its Lumigan formula to enhance eyelashes.

The agency's panel of outside eye and skin specialists voted unanimously that the drug's benefits outweighed its risks. However, the same panel voted 5-3 with one abstention that Allergan should be required to conduct follow-up studies to address questions about the drug's use among certain patient groups.

"I'm worried about off-label, nonsupervised use of this medication, and I'm concerned teenagers might use it three or four times a day instead of once," said Dr. Marijean Miller, an ophthalmologist with the Children's National Medical Center in Washington.

Other experts noted that only one African-American patient was included in company trials and said Allergan should be required to show the drug's effectiveness in that population.

The FDA is not required to follow the panel's advice, though it normally does. The agency is expected to make a decision on the drug in mid-2009.

The drug is already marketed to treat eye conditions stemming from glaucoma. In studies for that treatment, researchers first noticed the drug seemed to stimulate eyelash growth.

Irvine, Calif.-based Allergan plans to market the drug under the brand name Latisse, if it is approved as a cosmetic treatment.

A study conducted by Allergan showed once-daily application with the formula significantly increased prominence of lashes after four months. The study also met its secondary goals of increasing eyelash length, thickness and darkness.

Allergan has estimated that Latisse could garner more than $500 million in sales annually, however, analysts are more conservative about the product's short-term potential. Cowen & Co. analyst Ken Cacciatore projected in a research note that Latisse would reach $15 million in sales for 2009 and $30 million in 2010.

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