Dec. 5, 2008 -- An FDA advisory panel today recommended approving Latisse, a drug to promote longer, thicker, darker eyelashes.
Latisee is a spin-off of the glaucoma drug Lumigan. The FDA approved Lumigan in 2001 as an eyedrop. Eyelash growth is a known side effect of the drug.
Allergan Inc., the drug company that makes Lumigan, studied the drug to see how well it promoted eyelash growth, thickness, and darkness when dabbed like an eyeliner at the roots of the eyelashes on the upper eyelid.
In that study, 137 people used Latisse and 141 people used a placebo solution for 16 weeks. The result: Thicker, longer, darker eyelashes were more common by the end of the study in the Latisse group. And people in the Latisse group reported more satisfaction with their lashes than people who used the placebo.
Side effects, which were generally temporary and mild, included eye redness, which stopped when the use of the drug was discontinued, according to Allergan documents submitted to the FDA.
Lumigan's prescribing information notes that the drug may darken eyelid skin and gradually increase pigmentation of the iris, making eyes browner. Those iris color changes, which may not be noticeable for several months to years, may be permanent but don't progress after stopping Lumigan.
The Latisse study, however, doesn't report any cases of iris color changes. Unlike Lumigan, Latisse isn't meant to go directly on the eyes, and each Latisse dose uses only 5% of a Lumigan drop.
The FDA panel also 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, according to an Allergan news release.
Latisse isn't headed to the market just yet. The FDA considers, but doesn't always follow, the recommendations of its advisory panels. And if the FDA approves Latisse, it will be a prescription drug, not an over-the-counter cosmetic.
Allergan anticipates launching Latisse in 2009, according to a company news release.