FDA Panel Backs Allergan's Eyelash Enhancing Drug

Dec. 5, 2008— -- WASHINGTON (AP) - A panel of government experts said Friday aglaucoma drug from Allergan appears to be a safe and effective wayto make eyelashes longer and fuller.

Allergan, which makes Botox anti-wrinkle injections, has askedthe Food and Drug Administration to approve its Lumigan formula toenhance eyelashes for patients 18 and older.

The agency's panel of outside eye and skin specialists votedunanimously that the drug's benefits outweigh its risks.

"I have absolutely no reason to question the efficacy or theeffect of Lumigan," said Dr. M. Roy Wilson, chancellor of theUniversity of Denver. "I also want to emphasize that I don't haveany concerns about potential side effects on the eyelid."

However, the same panel voted 5-3 with one abstention thatAllergan should be required to conduct follow-up studies to addressquestions about the drug's use among certain patients.

"I'm worried about off-label, nonsupervised use of thismedication, and I'm concerned teenagers might use it three or fourtimes a day instead of once," said Dr. Marijean Miller, anophthalmologist with the Children's National Medical Center inWashington.

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

Panelists also discussed what types of physicians should be ableto prescribe the drug. Allergan would like any licensed physicianto be able to write a prescription. However, panelists debatedwhether younger patients should be able to get the drug only afterseeing an eye specialist.

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

The drug is already marketed to treat eye conditions stemmingfrom glaucoma. In studies for that treatment, researchers firstnoticed the drug seemed to stimulate eyelash growth.

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

A study conducted by Allergan showed once-daily application withthe formula significantly increased prominence of lashes after fourmonths. The study also met its secondary goals of increasingeyelash length, thickness and darkness.

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

Shares of Allergan rose $1.04, or 2.8 percent, to $37.44.

(Copyright 2008 by The Associated Press. All Rights Reserved.)