Botox Cosmetic Approved to Treat Crow’s Feet

Botox has been used off-label for years to smooth the appearance of crow’s feet and other fine lines on the face. Now, the U.S. Food and Drug Administration has approved BOTOX Cosmetic (onabotulinumtoxinA) to temporary improve the appearance of moderate to severe lateral canthal lines at the sides of the eyes, known as “crow’s feet,” in adults. BOTOX Cosmetic is the only FDA-approved drug treatment option for lateral canthal lines.

The FDA approved BOTOX Cosmetic in 2002 for the temporary improvement of glabellar lines (wrinkles between the eyebrows, known as frown lines) in adults. BOTOX Cosmetic works by keeping muscles from tightening so that wrinkles are less prominent.

BOTOX Cosmetic is administered via intramuscular injections. Treatment for both frown lines and crow’s feet can be given at the same time.

Studies establish Botox safety, effectiveness

BOTOX Cosmetic’s safety and effectiveness for treating lateral canthal lines were established in two clinical efficacy and safety studies. The studies enrolled 833 adult participants with moderate to severe crow’s feet who were randomly assigned to receive either Botox or a placebo. Results showed that those treated with Botox had greater improvement compared to the placebo in the appearance ofcrow’s feet.

The most common adverse reaction associated with the use of BOTOX Cosmetic for treatment of lateral canthal lines is eyelid edema, a condition in which the eyelids are swollen and contain excessive fluid.

The FDA approved Botox for the treatment of chronic migraine, severe underarm sweating, blepharospasm (eyelid spasm) and strabismus (misalignment of the eyes when one or both eyes turn inward or outward). Botox and BOTOX Cosmetic have a boxed warning that the effects of botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to botulism. Those symptoms include swallowing and breathing difficulties that can be life-threatening. There has not been a confirmed serious case of toxin spread when Botox or BOTOX Cosmetic has been used at the recommended dose for the approved indications.

Source: U.S. Food and Drug Administration