WASHINGTON — Federal regulators on Wednesday said a glaucoma drug from Allergan appears to make eyelashes longer and fuller, and experts soon will assess the safety of that new use.
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Allergan, which makes Botox anti-wrinkle injections, has asked the Food and Drug Administration to approve its bimatoprost formula to enhance eyelashes. A panel of experts on Friday will comment on the drug's safety and effectiveness as a cosmetic.
The drug is already marketed under the name Lumigan, 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.
The FDA said in documents posted online Wednesday that Allergan's drug appears to significantly enhance eyelashes, as measured by "before and after" photos.
Allergan measured Latisse's effect using a four point scale, ranging from "minimal" eyelash prominence to "very marked" prominence. The drug is applied once daily to the base of the eyelashes.
After four months using the formulation, 78 percent of patients had at least "minimal" eyelash growth, compared with just 18 percent for patients taking a placebo.
The FDA said four patients dropped out of the study due to eye problems, including dryness and inflammation.
Regulators will ask a panel of experts on Friday whether the drug's benefits outweigh its risks. The FDA will also ask panelists whether the company should be required to conduct additional, follow-up studies.
The FDA is not required to follow the group's advise, though it usually does.
Allergan noted in its own online posting that its drug would be "the first eyelash enhancement product to be developed under FDA guidance and manufactured under good manufacturing practices."
Allergan estimates the global market for mascara at about $3.7 billion in annual sales. If Latisse is approved, it could garner more than $500 million annually, according to the company. Allergan also said the drug, which it expects to be approved in 2009, will only be available via prescription.
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