Irvine, California, August 4, 2026
Allergan Aesthetics, an AbbVie company, has announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) for BOTOX® Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of masseter muscle prominence (MMP) associated with masseter muscle activity in adults. If approved, BOTOX® Cosmetic would become the first and only neurotoxin approved in the United States for treating masseter muscle prominence, expanding its portfolio to five FDA-approved aesthetic indications. The regulatory submission is supported by two pivotal Phase 3 clinical studies that demonstrated statistically significant improvements in jawline contour and patient satisfaction while maintaining the product’s established safety profile. The FDA acceptance marks another important regulatory milestone for Allergan Aesthetics as it continues expanding evidence-based, minimally invasive treatment options in the rapidly growing medical aesthetics market.
Phase 3 Clinical Studies Support Expanded BOTOX Cosmetic Indication
The supplemental application is based on results from Phase 3 clinical trials M21-416 and M21-417, which successfully met their primary endpoints by demonstrating statistically significant reductions in the severity of masseter muscle prominence compared with placebo. The studies also showed that patients receiving BOTOX® Cosmetic reported substantially higher treatment satisfaction, with approximately twice as many participants indicating they were “Very Satisfied” or “Satisfied” compared with those receiving placebo. Importantly, investigators reported that the therapy maintained a consistent safety profile, with no new safety signals identified during clinical evaluation. Masseter muscle prominence contributes to a broader or square-shaped lower face, and growing consumer demand for non-surgical facial contouring has increased interest in scientifically validated treatment options. If approved, the new indication would provide healthcare professionals with the first FDA-approved neurotoxin specifically indicated to improve jawline definition by treating excessive masseter muscle activity, offering patients a clinically proven alternative to more invasive cosmetic procedures.
FDA Review Expands Innovation in Medical Aesthetics
The FDA acceptance reflects Allergan Aesthetics’ ongoing investment in aesthetic research and development while reinforcing the versatility of the globally recognized BOTOX® Cosmetic brand. Currently, BOTOX® Cosmetic is approved in the United States for the temporary improvement of glabellar lines, lateral canthal lines (crow’s feet), forehead lines and platysma bands. Approval for masseter muscle prominence would add a fifth aesthetic indication, further expanding its clinical utility for facial assessment and individualized treatment planning. Company leadership noted that modern aesthetic medicine increasingly focuses on comprehensive facial harmony rather than isolated treatment areas, creating demand for innovative, minimally invasive procedures capable of improving overall facial balance. The regulatory review also demonstrates Allergan Aesthetics’ commitment to expanding scientifically validated applications for established biologic therapies while supporting physicians with evidence-based treatment options that address evolving patient expectations in facial aesthetics.
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Regulatory Milestone Strengthens Aesthetic Medicine Leadership
The FDA’s acceptance of the supplemental application represents another important milestone in the continued evolution of injectable biologic therapies within the global aesthetics industry. As patient demand continues rising for non-surgical cosmetic procedures, manufacturers are increasingly investing in rigorous clinical research to validate new therapeutic indications supported by high-quality evidence. If approved, BOTOX® Cosmetic would become the only neurotoxin approved across five separate aesthetic indications in the United States, strengthening Allergan Aesthetics’ leadership position in the competitive facial aesthetics market. The submission also highlights the importance of expanding regulatory-approved treatment options that deliver consistent efficacy while maintaining well-established safety standards. With robust Phase 3 clinical data supporting the application, the FDA review represents a significant advancement for both physicians and patients seeking scientifically validated solutions for facial contouring through minimally invasive biologic therapies.
Source: Allergan Aesthetics press release
