An FDA advisory panel today recommended approving Latisse, a drug originally used to treat glaucoma to promote longer, thicker, darker eyelashes. The drug manufactured by Botox manufacturer Allergan Inc. is a spin-off of the glaucoma drug Lumigan approved by the FDA in 2001 and was initially used to relieve eye pressure when patients reported an unusual side effect of enhanced eyelash growth.

The company Allergan Inc. conducted a study to see how well the drug promoted eyelash growth, thickness and darkness when it was applied like an eye liner at the roots of the eyelashes on the upper eyelid. In the study 137 participants used Latisse while 141 used a placebo for 16 weeks. Researchers then rated the appearance of the eyelashes on a four point scale ranging from "minimal" to "very marked." The FDA review said that at the end of the 16 weeks 78 % of the patients who used the drug had a minimum of a one point improvement as compared to the placebo group who had only an 18 % improvement. The side effects of the drug are said to mild and temporary ranging from eye redness to irritation and changing of eye color most of which subsided once the drug was discontinued. "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.

Many panelists were concerned about the safety of the drug in a long term use and the lack of adequate studies on its long term safety as it must be applied continuously on the lashes to prevent them shrinking back to their original size. Questions were also raised about the chances of the drug being inappropriately used by teenagers and others even though this would be a prescription drug. "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.

According to an Allergan news release the FDA panel does not always follow recommendations of its advisory panel and has recommended further studies to assess Latisse's use in certain groups of patients, such as young patients and people who lost their eyelashes because of chemotherapy.

"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. Allergan anticipates launching Latisse in 2009, according to a company news release.