Positive topline results show Botox Cosmetic may improve aesthetics of platysma prominence

Key takeaways:

• Results showed statistically significant improvement in platysma prominence after treatment with Botox Cosmetic (P < .0001).
• If approved, Botox Cosmetic will be the first neurotoxin approved for this indication.

Allergan Aesthetics, an AbbVie company, announced in a press release positive topline results from the second of three phase 3 studies evaluating Botox Cosmetic for the treatment of moderate to severe platysma prominence.

The phase 3 trial, M21-310, found that Botox Cosmetic (onabotulinumtoxinA) demonstrated statistically significant improvement to platysma prominence, an aesthetically unappealing condition that disrupts the neck, jawline and lower face of individuals due to a contraction of the platysma muscle, according to the press release.

“Platysma prominence occurs as part of the natural aging process and patients need noninvasive treatment options for the appearance of the lower face and neck and to help improve symmetry between the upper and lower face,” Sachin Shridharani, MD, FACS, lead clinical investigator for the M21-310 study, said in the release. “Treatment with a proven neurotoxin may help relax the platysma muscle and thus reduce the appearance of vertical neck bands and improve jawline definition.”

The study, which included 426 adults with moderate to severe platysma prominence, achieved its primary endpoint of inducing higher rates of statistically significant improvement in patients compared with placebo (P < .0001), according to both investigator and subject assessments.

The study also achieved all secondary endpoints, including patients reporting improvements in emotional and psychosocial distress from their condition as well as high overall treatment satisfaction.

All treatment-emergent adverse events were mild and consistent with Botox’s prior safety profile, according to the press release.

Results from the ongoing phase 3 extension trial are expected later this year. The company also plans to submit a regulatory application to the FDA at the end of this year. If approved, Botox Cosmetic will be the first neurotoxin approved for platysma prominence, according to the release.