FDA approves Botox for crow’s feet

September 17, 2013

The Food and Drug Administration has approved Botox (onabotulinumtoxinA, Allergan) for the temporary improvement of moderate-to-severe lateral canthal lines.

The Food and Drug Administration has approved Botox (onabotulinumtoxinA, Allergan) for the temporary improvement of moderate-to-severe lateral canthal lines. 

The approval follows results from two safety and efficacy clinical trials, according to a news release. The studies randomized 833 adults with moderate-to-severe lateral canthal lines to receive treatment with Botox or placebo. Patients treated with Botox had greater improvement in the appearance of lateral canthal lines compared with those treated with placebo, studies indicated.

According to Hema Sundaram, M.D., a Washington dermatologist and cosmetic surgeon in private practice, the first reaction of some dermatologists and cosmetic surgeons may be: "I'm already using it for crow's feet anyway, so what difference does it make?"

She stresses that this approval carries great significance to both dermatologists and patients.

“First, there are the medicolegal implications - that treatment of crow's feet will now be on FDA labeling rather than off-label. This allows the manufacturing company (Allergan) to inform and educate consumers - our patients and potential patients - directly about this treatment option. The result is likely to be a marked expansion in the number of patients seeking botulinum toxin treatment of their crow's feet,” Dr. Sundaram says. “Market research has shown that the brand of toxin that a patient receives is most often determined by patient preference. This is not the case for soft tissue fillers, where the treating physician plays a larger role in product selection. Given this market research, we can readily understand the rationale for the company to spend considerable time, effort and money on securing this new approval for Botox."

Additionally, “Patient education will be balanced with physician education so that patients' results can be optimized. Over the next couple of years, we will see a number of new physician education initiatives that will focus on advancing and refining our techniques for pretreatment analysis and implementation of individualized toxin treatment strategies, for an increasingly diverse patient population," she says. "In addition to the typical baby boomers and older generation X members, the patient population for toxin treatments includes younger and older patients, patients of color, and men. This is a very encouraging educational trend that will greatly benefit both our patients and us.”

Botox was approved in 2002 for the temporary improvement of glabellar lines in adults. Treatment for glabellar lines and lateral canthal lines can be administered at the same time.

The most common adverse reaction resulting from treatment of crow’s feet was eyelid edema, the FDA stated.

Disclosures: Dr. Sundaram serves as a clinical investigator and/or consultant for Allergan, Ipsen, Medicis/Valeant, Mentor/Johnson & Johnson, Merz and QMed/Galderma.

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