The US Food and Drug Administration (US FDA) has approved a new use for Botox Cosmetic (onab-otulinumtoxinA) for the temporary improvement in the appearance of moderate to severe lateral canthal lines, 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 wrinkles are less prominent.
“This additional indication will provide people with a new FDA approved treatment option for those seeking a smoother appearance by temporarily minimising the appearance of crow’s feet at the sides of the eyes,” said Susan Walker, Director of the Division of Dermatology and Dental Products in the FDA’s Center for Drug Evaluation and Research.
Botox Cosmetic is administered via intramuscular injections. Treatment for both frown lines and crow’s feet can be given at the same time.
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 lateral canthal lines who were randomly assigned to receive Botox or placebo. Results showed that those treated with botox had greater improvement compared to placebo in the appearance of lateral canthal lines.
FDA