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An FDA advisory panel supported approval of
Latisse, a drug traditionally used to treat glaucoma, for use in adults who want
to have thicker and longer eyelashes. The panel announced the decision to back
the drug for use in the United
States but also called for more studies to
make sure the drug really is safe.
The agency approved the drug Lumigan in
2001 as an eyedrop. Allergan Inc., the drug company that makes Lumigan, is now
seeking FDA’s approval to market the new use under the brand name Latisse.
The Latisse study involved 278 people; half
used Latisse and the rest used a placebo solution for 16 weeks. At the end of
the study, those who used Latisse had thicker, longer and darker eyelashes
compared with patients receiving a placebo. A total of four patients in the
Latisse and the control group quit during the study period because of side
effects like dry eye and eye inflammation.
“I have absolutely no reason to question
the efficacy,” panelist M. Roy Wilson, an ophthalmologist from the University of Colorado, was quoted as saying.
The FDA panel recommended further studies
to asses Latisse’s use in certain group of patients, such as patients younger
than 18, people who suffered the side-effects of chemotherapy, on which the
drug has not been tested.
In November, the FDA announced that a
product promoted to increase eyelash growth was considered dangerous because it
contained bimatoprost, an active ingredient which is used by patients with
elevated pressure inside the eye.
The agency said an increased quantity of this
substance may damage the optic nerve, as it may decrease the prescription drug’s
effectiveness. The applicator tubes that had been sold and distributed by San
Jose, California-based Jan Marini Skin Research, Inc. since September 2006 were
likely to cause swelling of the retina and inflammation of the eye, according
to the FDA.
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