The manufacturer of onabotulinumtoxinA (Botox Cosmetic) announced it has filed a supplemental Biologics License Application (sBLA) to the FDA for onabotulinumtoxinA for improving the appearance of “marked to very marked masseter muscle prominence (MMP) associated with masseter muscle activity in adults.”

If approved, this would be the fifth aesthetic indication for onabotulinumtoxinA, according to the August 4 press release from the manufacturer, Allergan Aesthetics. MMP can lead to a wider or more “square” appearance in the lower face, and submission for the new indication addresses the “growing patient interest in nonsurgical facial contouring options,” the company said. 

The sBLA submission followed positive results from two phase 3 clinical studies (M21-416 and M21-417) for the indication. Approximately 200 adults with MMP were enrolled in each study at approximately 20 sites in the US. Both trials met their primary endpoints, demonstrating significant improvements in the severity of MMP compared with placebo (P = .0046 and P = .0014, respectively). Participants also reported high overall satisfaction, with twice as many patients treated with onabotulinumtoxinA reporting they were “Very Satisfied” or “Satisfied” compared with those who received placebo, according to the press release.

The four current FDA-approved indications for onabotulinumtoxinA are for the temporary improvement in the appearance of moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity, moderate-to-severe lateral canthal lines associated with orbicularis oculi activity, moderate-to-severe forehead lines associated with frontalis activity, and moderate-to-severe platysma bands associated with platysma muscle activity.

No new safety signals were identified in the two recent trials and to date, no definitive serious adverse events related to the spread of the toxin effect associated with dermatologic use of onabotulinumtoxinA have been reported, according to the release. The most frequently reported adverse reactions to date following injection of onabotulinumtoxinA for different indications include eyelid ptosis, facial pain and headaches, facial paresis, and muscular weakness. Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, have been reported following unapproved use.

No information was available about when the FDA’s decision regarding the new indication was expected.

The studies were sponsored by AbbVie.

Scott Harris has covered dermatology, rheumatology, and assorted healthcare issues for various news outlets and nonprofit organizations for more than a decade.