The U.S. Food and Drug Administration has approved onabotulinumtoxinA (BOTOX Cosmetic from Allergan Aesthetics) for the temporary improvement in the appearance of moderate to severe platysma bands in adult patients. The approval marked the fourth aesthetic indication for the neurotoxin product, making it the first to be approved for use below the face for aesthetic purposes, according to a press release from PR Newswire.
The platysma muscle, when contracted, can cause visible bands on the neck and affect jawline definition. OnabotulinumtoxinA works by temporarily reducing underlying muscle activity.
OnabotulinumtoxinA is indicated for forehead lines, glabellar lines, lateral canthal lines, and platysma bands. The U.S. Food and Drug Administration (FDA)-approved dosing for platysma bands ranged from 26 to 36 units based on severity.
The approval followed phase III clinical studies in which the primary endpoint was met, demonstrating improvement in platysma band appearance from baseline with onabotulinumtoxinA vs placebo (P < .0001). The measure incorporated both investigator and subject assessments.
Secondary endpoints, measured by patient-reported outcome instruments, were also met. In two clinical studies, 65% and 62% of patients reported being "very satisfied" or "satisfied" with neck and jawline definition appearance 14 days posttreatment, compared with 12% among those who received placebo.
"With the approval of BOTOX Cosmetic for the treatment of platysma bands, including precise injection patterns and dosing, I can now confidently offer my patients a treatment option that can help deliver the results they are looking to achieve," remarked Terrence Keaney, MD, a board-certified dermatologist and clinical trial investigator.
This approval provided dermatologists with a nonsurgical, injectable option to treat patients concerned about platysma bands. Allergan Aesthetics reported that millions of U.S. consumers were bothered by this aesthetic concern, citing a 2021 survey where 3.8% of participants indicated being "very bothered" or "extremely bothered" by their platysma bands.
