FDA Approves Botox Cosmetic for Moderate to Severe Forehead Lines

Tuesday, October 03, 2017 | FDA Approval/Clearance , Allergan

The FDA approved Allergan plc's Botox Cosmetic for its third indication, the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity in adults. This approval makes the brand the first and only neurotoxin indicated for three facial treatment areas—forehead lines, crow's feet lines, and glabellar lines. Botox Cosmetic is  the only neurotoxin brand to receive approval of aesthetic indications beyond glabellar lines in the US.

"Allergan recognizes that forehead lines are a top area of concern for patients," says David Nicholson, Chief Research and Development Officer at Allergan. "Our goal in pursuing a third indication for BO Cosmetic for the temporary improvement in the appearance of moderate to severe forehead lines was based on our desire to study the patient selection, dosing and injection pattern to help provide optimal treatment outcomes."

In 2002, Botox Cosmetic received its first FDA approval to temporarily improve the appearance of moderate to severe frown lines between the eyebrows (glabellar lines). The momentum continued in 2013 when Botox Cosmetic was approved for the temporary improvement in the appearance of moderate to severe crow's feet lines. The addition of this third indication furthers Allergan's mission to continue providing patients and physicians with products designed to address specific patient needs.  

"As a physician, I've been using Botox Cosmetic since it was FDA approved in 2002, but for years my patients have also inquired about how to treat forehead lines. With this latest indication for Botox Cosmetic, I have an FDA-approved product I already know and trust, that can improve the appearance of the forehead," says Dr. Steven Fagien, an Oculoplastic Surgeon in Boca Raton, FL and lead clinical trial investigator. "I am proud to have worked closely with Allergan to establish criteria for proper patient selection, dosing and injection pattern for forehead line treatment and am pleased to see that the company is providing extensive injector training to help ensure optimal results."

In clinical trials, Botox Cosmetic demonstrated efficacy compared with placebo in the reduction of the severity of forehead lines, as assessed by both the investigator and the subject at Day 30 (primary endpoint): 61 percent of subjects in study one and 46 percent of subjects in study two met the primary endpoint compared with placebo (0 percent in Study one and 1 percent in Study two). Similar response rates were seen across three treatments cycles with Botox Cosmetic.

Approved for use in over 75 countries, the safety and efficacy of Botox Cosmetic have been evaluated in Allergan clinical studies and described in nearly 500 peer-reviewed articles in scientific and medical journals.  Botox Cosmetic is manufactured in a state-of-the art facility under strict quality and safety standards.


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