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Refresh - Aesthetics & Wellness Explains FDA Review of Botox Cosmetic for Masseter Muscle Prominence and Nonsurgical Jawline Slimming

Refresh - Aesthetics & Wellness, a physician-led medical aesthetics and wellness practice, is highlighting an important regulatory development that could expand the future of nonsurgical lower-face contouring for patients in Vero Beach and throughout Florida.

On August 4, 2026, Allergan Aesthetics announced that the U.S. Food and Drug Administration accepted its supplemental Biologics License Application for Botox Cosmetic for the temporary improvement of marked to very marked masseter muscle prominence associated with muscle activity in adults. The FDA will now review the clinical evidence before deciding whether to approve the proposed indication.

If approved, Botox Cosmetic would become the first and only neurotoxin approved in the United States specifically for masseter muscle prominence. It would also become the product’s fifth FDA-approved cosmetic indication, joining treatments for frown lines, forehead lines, crow’s feet and platysma bands connecting the jaw and neck.

Masseter muscle prominence occurs when the masseter muscles located along the sides of the jaw appear enlarged or especially noticeable. The condition can contribute to a wider or more square-shaped lower face. Temporarily reducing masseter muscle activity may create a slimmer-looking lower face and improve the appearance of jawline shape and definition.

“This submission builds on the depth and versatility of Botox Cosmetic,” said Darin Messina, Ph.D., AbbVie’s senior vice president and head of aesthetics research and development.

The application is supported by two Phase 3 clinical studies, identified as M21-416 and M21-417. Both studies met their primary endpoints and demonstrated statistically significant improvements in the severity of masseter muscle prominence compared with placebo. According to Allergan Aesthetics, twice as many patients treated with Botox Cosmetic reported being satisfied or very satisfied with their treatment compared with those receiving placebo. The studies also identified no new safety signals.

The FDA’s acceptance of the application is not the same as FDA approval. As of August 6, 2026, Botox Cosmetic has not been approved in the United States specifically for masseter muscle prominence or jawline slimming. A final regulatory decision will follow the FDA’s review of the submitted clinical and safety information.

The development reflects growing interest in comprehensive facial assessments that consider the entire face rather than treating individual lines or isolated areas. Lower-face treatments may involve the muscles, skin, facial structure or volume, making proper patient evaluation an important part of determining an appropriate treatment plan.

At Refresh - Aesthetics & Wellness, injectable consultations are performed within a physician-led model under the medical direction of Christopher Senger, M.D. Each treatment recommendation is based on the patient’s anatomy, medical history, goals and suitability for the proposed procedure.

Botox Cosmetic and other botulinum toxin products can cause side effects and carry a boxed warning regarding the possible spread of toxin effects beyond the injection area. Patients should receive injectable treatments only from qualified medical professionals who understand facial anatomy, proper dosing and the potential risks associated with treatment.

Refresh will continue following the FDA review and any future decision concerning Botox Cosmetic for masseter muscle prominence. Patients interested in facial balancing, jawline definition or other injectable treatments can schedule a complimentary consultation at the Vero Beach office to discuss currently available treatment options.

The Vero Beach office is open Monday through Friday from 10 a.m. to 6 p.m. and Thursdays until 9 p.m. For additional information or to schedule a consultation, call (772) 213-9544 or visit the Refresh - Aesthetics & Wellness website.

About Refresh - Aesthetics & Wellness: Refresh is a physician-led, family-owned medical aesthetics and wellness practice with nine Florida locations serving Vero Beach, Port St. Lucie, Jupiter, Wellington, Fort Lauderdale, Palm Harbor, St. Petersburg, Tampa and Brandon. Services include laser treatments, wrinkle relaxers, dermal fillers, skin rejuvenation and medically supervised wellness programs.

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