The US Food and Drug Administration (FDA) has approved use of onabotulinumtoxinA (Botox Cosmetic, Allergan) for temporary improvement in the appearance of moderate to severe lateral canthal lines, also known as crow’s feet, in adults. Botox Cosmetic is currently the only FDA-approved drug treatment option for lateral canthal lines, the FDA said today.
The agency approved Botox Cosmetic in 2002 for the temporary improvement of glabellar lines (frown lines) in adults. Botox Cosmetic works by keeping muscles from tightening, so 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, the FDA said.
Boxed Warnings
The approval of Botox Cosmetic for treating lateral canthal lines was based on 2 clinical efficacy and safety studies involving 833 adults with moderate to severe lateral canthal lines who were randomly assigned to receive either Botox Cosmetic or placebo.
The results showed that those treated with Botox Cosmetic had greater improvement compared with placebo in the appearance of lateral canthal lines, the FDA said.
BOTOX® is a prescription medicine that is injected into muscles and also used for the following:
- to treat overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults 18 years and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken.
- to prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older
- to treat increased muscle stiffness in elbow, wrist, and finger muscles in people 18 years and older with upper limb spasticity
- to treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older
- to treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years and older
- to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in people 18 years and older
