The U.S. Food and Drug Administration has granted Allergan’s Botox Cosmetic approval 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 neurotoxin indicated for three facial treatment areas: forehead lines, crow’s feet lines and glabellar lines.
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% of subjects in study one and 46% of subjects in study two met the primary endpoint compared with placebo (0% in study one and 1% in study two).
“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 Botox 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.”