If approved, the neurotoxin would be the first indicated for the temporary improvement of marked to very marked masseter muscle prominence in the United States.
Allergan Aesthetics, an AbbVie company, announced that the Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of marked to very marked masseter muscle prominence.
If approved, Botox Cosmetic would become the first and only neurotoxin indicated for this condition in the US. This would also mark the fifth aesthetic indication for the product, according to the company.
Masseter muscle prominence can contribute to the appearance of a wider or more square lower face. The submission addresses patient interest in non-surgical facial contouring to achieve improved jawline definition, shape, and a more slimming jawline overall.
“This submission builds on the depth and versatility of Botox Cosmetic and reflects our continued investment in advancing aesthetic medicine,” says Darin Messina, SVP, head of aesthetics research and development at AbbVie, in a release. “At Allergan Aesthetics, our approach to innovation includes both developing new treatment options and continuing to expand the potential of established products.”
The submission is supported by two Phase 3 clinical studies, M21-416 and M21-417, which both met their primary endpoints. According to the company, the studies demonstrated statistically significant improvements in the severity of masseter muscle prominence compared with a placebo. The safety profile remained consistent with established uses, and no new safety signals were identified.
Patient satisfaction was also recorded during the trials. Twice as many patients treated with Botox Cosmetic reported they were “very satisfied” or “satisfied” compared with those who received a placebo.
“Patients are increasingly seeking overall facial assessments with non-surgical options to address aesthetic needs for the lower face,” says Steve Yoelin, MD, a coordinating clinical investigator, in a release. “As facial assessment continues to evolve beyond individual treatment areas, this indication would further broaden the clinical utility of Botox Cosmetic, if approved, by providing an important new treatment option.”
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