FDA Approves Botox for Crow's Feet
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WEDNESDAY, Sept. 11 (HealthDay News) -- Adults bothered by the appearance of crow's feet -- lines at the outside corners of the eyes -- have a new treatment option.
The U.S. Food and Drug Administration on Wednesday approved the use of Botox Cosmetic for temporary improvement of moderate to severe crow's feet.
Botox Cosmetic (onabotulinum toxin A) has been approved in the United States since 2002 to treat frown lines between the eyebrows. It works to make wrinkles less prominent by keeping facial muscles from tightening, according to an FDA news release.
"This additional indication will provide people with a new FDA-approved treatment option for those seeking a smoother appearance by temporarily minimizing the appearance of crow's feet at the sides of the eyes," Dr. Susan Walker, director of the division of dermatology and dental products in the FDA's Center for Drug Evaluation and Research, said in the news release.
Botox Cosmetic is given by intramuscular injection. Treatment for frown lines (officially known as glabellar lines) and crow's feet (lateral canthal lines) is given at the same time.
The treatment underwent two clinical trials to establish its safety and effectiveness for improving crow's feet. In all, 833 adults with moderate to severe lines were randomly assigned to get Botox Cosmetic or an inactive placebo. Participants in the Botox Cosmetic group showed greater improvement in their appearance.
Eyelid edema -- in which the eyelids are swollen and contain excessive fluid -- was the most common side effect reported.
Botox Cosmetic is manufactured by Allergan Inc., based in Irvine, Calif.
-- Lisa Esposito
SOURCE: U.S. Food and Drug Administration, news release, Sept. 11, 2013