Clinical Trials

Allergan Aesthetics’ BOTOX Cosmetic moves closer to new jawline treatment approval

This submission builds on the depth and versatility of BOTOX Cosmetic and reflects our continued investment in advancing aesthetic medicine

Allergan Aesthetics has reached a key regulatory milestone after the US FDA accepted its supplemental Biologics License Application (sBLA) for BOTOX Cosmetic as a potential treatment for temporary improvement in the appearance of marked to very marked masseter muscle prominence (MMP).

If approved, BOTOX Cosmetic would become the first and only neurotoxin indicated in the US for this condition, expanding its portfolio to a fifth aesthetic indication and reinforcing the brand’s position in non-surgical aesthetic medicine.

"This submission builds on the depth and versatility of BOTOX Cosmetic and reflects our continued investment in advancing aesthetic medicine," said Darin Messina, senior vice president, head of aesthetics research and development, AbbVie. "At Allergan Aesthetics, our approach to innovation includes both developing new treatment options and continuing to expand the potential of established products. The pursuit of a fifth aesthetic indication demonstrates that commitment to addressing evolving patient needs."

Masseter muscle prominence can contribute to the appearance of a wider or more square lower face. The regulatory submission responds to growing interest among patients seeking non-surgical facial contouring solutions, including options designed to enhance jawline definition, improve facial shape and create a more streamlined appearance.

If approved, the new indication would offer aesthetic specialists and patients a clinically studied, science-backed option for addressing lower-face aesthetic concerns.

"Patients are increasingly seeking overall facial assessments with non-surgical options to address aesthetic needs for the lower face," said Steve Yoelin, a coordinating clinical investigator with over 25 years of experience in minimally invasive medical aesthetics.

"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."

The sBLA is supported by results from two Phase 3 clinical studies which both achieved their primary endpoints. The studies showed statistically significant improvements in the severity of masseter muscle prominence among patients treated with BOTOX Cosmetic compared with placebo.