FDA Approves Botox Cosmetic to Treat Crow's Feet Lines in Adults
The FDA recently approved Botox Cosmetic (onabotulinumtoxinA) for an additional indication to temporarily treat moderate to severe lateral canthal lines. Allergan's Botox Cosmetic was first approved in the United States in 2002 for the temporary improvement of moderate to severe glabellar lines for patients aged 18 to 65 years.
The safety and efficacy of Botox Cosmetic as a treatment for crow's feet lines was demonstrated in two randomized, multi-center, placebo-controlled clinical trials, according to Allergan. The studies enrolled more than 1,350 patients with 833 of them receiving treatment with Botox Cosmetic. The trial demonstrated that Botox Cosmetic was an effective treatment compared to the control group, which did not receive Botox Cosmetic treatment.
“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,” 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, in an Allergan release. Dr. Dayan is also the Co-Chief Editor of Practical Dermatology's sister publication Modern Aesthetics.
“Allergan has remained the leader in the facial aesthetic industry by prioritizing research and development that provides physicians and patients with innovative treatments and fully explores the additional indications for our product portfolio,” said Scott W. Whitcup MD, Executive Vice President, Research and Development, Chief Scientific Officer, Allergan in a press release. “We are pleased that the FDA has approved a new indication for Botox Cosmetic to temporarily improve the appearance of crow's feet lines. With this approval, Botox Cosmetic is now the only pharmaceutical approved to treat both crow's feet lines and frown lines between brows. This approval will enhance our ability to work with and train aesthetic physicians on the science of administering Botox Cosmetic to yield the best possible outcomes for patients.”