The FDA has approved Botox Cosmetic (onabotulinumtoxinA, Allergan Aesthetics) for the temporary improvement in the appearance of moderate to severe platysma bands in adults, marking its fourth approved aesthetic indication. This approval positions Botox Cosmetic as the first neurotoxin with FDA approval for forehead lines, frown lines, crow’s feet, and platysma bands.
The approval was supported by data from two randomized, double-blind, placebo-controlled phase 3 clinical trials (Study M21-309 [NCT04949399] and Study M21-310 [NCT04994535]). These trials evaluated Botox Cosmetic for the temporary improvement in the appearance of moderate to severe platysma bands from baseline compared to placebo.
Clinical Trial Results
In the phase 3 trials, subjects were randomly assigned to receive a single treatment of Botox Cosmetic (26, 31, or 36 units) or placebo, based on baseline severity. The primary efficacy endpoint was achieving a grade of 1 or 2 (minimal or mild) and at least a 2-grade improvement from baseline in platysma band severity at maximum contraction, assessed by both the investigator and the subject at day 14.
The results demonstrated statistical significance for the improvement in the appearance of platysma bands from baseline with Botox Cosmetic compared to placebo (P < 0.0001). Specifically, in Study 1, 32% (n = 63) of subjects treated with Botox Cosmetic achieved the primary endpoint compared to 2% (n = 4) in the placebo group. In Study 2, 31% (n = 64) of subjects in the Botox Cosmetic group met the primary endpoint versus 0% (n = 0) in the placebo group. All secondary endpoints were also met, as measured by patient-reported outcome instruments; approximately two-thirds of patients reported being “very satisfied” or “satisfied” with the appearance of their vertical neck bands and jawline definition 14 days after treatment with Botox Cosmetic, compared to 12% in both studies with placebo.
Impact and Future Directions
Darin Messina, PhD, Senior Vice President of Aesthetics R&D at Allergan Aesthetics, noted that this approval provides a proven, safe, and effective treatment paradigm for platysma bands. It allows for standardized injector training through the Allergan Medical Institute, promoting safe and optimal outcomes. The approval also enables direct-to-consumer marketing, which can increase awareness of Botox Cosmetic as a viable treatment option.
According to Lara Devgan, MD, MPH, FACS, while neuromodulators have been used off-label for platysma bands for years, this FDA approval brings heightened awareness and greater patient education to the treatment of platysma bands, potentially leading to a higher level of patient inquiries. She added, "From a practical standpoint, it will make it easier to discuss platysma band treatment with patients, as they may have greater familiarity with it as an option."
With this approval, Botox Cosmetic offers a non-surgical, injectable option to temporarily improve the appearance of moderate to severe vertical bands connecting the jaw and neck in adults, addressing a previously limited treatment landscape.
