FDA Approves BOTOX® for Improvement of Crow’s Feet Lines in Adults

Newest Indication for Number-One Prescribed Facial Aesthetic Treatment in U.S.

Can Help Improve Appearance of Lines Around the Eyes

September 11, 2013 02:54 PM Eastern Daylight Time

IRVINE, Calif.–(BUSINESS WIRE)–Allergan, Inc., (NYSE: AGN) today announced approval by the U.S. Food and Drug Administration (FDA) to market BOTOX® Cosmetic (onabotulinumtoxinA), for an additional indication to temporarily treat moderate to severe lateral canthal lines, commonly known as “crow’s feet” lines. BOTOX® Cosmetic is the first and only product of its kind approved for this indication. BOTOX® Cosmetic, approved in the United States in 2002 for the temporary improvement of moderate to severe glabellar lines (frown lines between the brows) for patients aged 18 to 65 years, remains the number-one minimally invasive aesthetic medical treatment globally.

With this approval, BOTOX® Cosmetic is now the only pharmaceutical approved to treat both crow’s feet lines and frown lines between brows.

“Crow’s feet lines are defined as the lines that extend around the corner of the eye area. They result from years of repetitive squinting and smiling,” said Dr. Steven Dayan, Founder of DeNova Research, Clinical Assistant Professor at the University of Illinois and a clinical investigator in the BOTOX® Cosmetic crow’s feet clinical trials. “I often see patients who are bothered by their crow’s feet lines, so I am very pleased that Allergan has conducted additional research to receive FDA approval of BOTOX® Cosmetic for this new indication. Based on the clinical evidence, I can now provide my patients with an FDA-approved option to address the crow’s feet lines that develop around the eyes.”

BOTOX® Cosmetic is a prescription medication that is injected into the muscles around the eye area to temporarily improve the look of moderate to severe crow’s feet lines in adults. It is a quick procedure that generally requires no downtime or recovery. BOTOX® Cosmetic works by blocking nerve impulses and reducing movement to the muscles around the eye area. The decreased muscle activity helps lessen the appearance of moderate to severe crow’s feet lines for noticeable results that do not radically change facial appearance or make a patient look as if they have had “work done.”

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