As you all know Botox was originally approved by the FDA for treatment of other medical conditions such as Cervical dystonia, Severe primary axillary hyperhidrosis (sweating), Strabismus and Blepharospasm. On Wednesday 9/11/2013, the US FDA approved Botox for treatment of crow’s feet around the lateral aspect of the eyes.
Botox Cosmetic (onabotulinum toxin A) has been approved in the US since 2002 to treat frown lines between the eyebrows. It makes wrinkles less prominent by preventing the facial muscles from activating. Botox is given via an intramuscular injection for the treatment for frown lines, also known as glabellar lines and crow’s feet which are called lateral canthal lines.
“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.
The approval was based on two clinical trials to establish its safety and effectiveness for improving crow’s feet. More than 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. The most common reported side-effect was eyelid edema which is swelling in the the eyelids due to excessive fluid.
Botox Cosmetic is manufactured by Allergan Inc., based in Irvine, Calif.