Dermatologists continue to await an FDA decision on DaxibotulinumtoxinA from Revance Aesthetics. A decision on the late-stage neuromodulator was delayed when COVID-19-related restrictions interfered with a regulatory required site visit.

“What makes this botulinum toxin unique is that it has been evaluated in clinical trials for a longer duration than the currently available botulinum toxins. It has demonstrated efficacy for duration of 24 weeks or six months,” observes Jeanette Black, MD in an interview. “Only time will tell if this botulinum toxin will really offer a duration for six months in a real life setting. But I and my colleagues are very excited to see how this new botulinum toxin will play out in our practices, potentially offering a better duration and higher patient satisfaction for our patients.”

Speaking as part of the Aesthetics Dispatches video series (available from our sister site: ModernAesthetics.com), Dr. Black noted that many patients indicate they would prefer a longer-lasting neurotoxin. “We hope that a longer duration and a new botulinum toxin will help expand the market. As every patient is unique and has different patient goals, and every injector offers a different type of practice and curates a different type of patient, it is great to offer different botulinum toxins for each individual’s goals.”

If approved, DaxibotulinumtoxinA will join existing neuromodulators Botox (Allergan), Dysport (Galderma), Xeomin (Merz Aesthetics), and Jeuveau (Evolus). “Expanding the market with new botulinum toxins available helps to drive competition from pharmaceutical industries, helps to encourage patients to seek treatments, and helps to expand the market of cosmetics,” Dr. Black says.

Restylane Defyne Targets Chins

Restylane Defyne (Galderma) is now approved for the augmentation and correction of mild to moderate chin retrusion in adults over the age of 21.

Results of a pivotal Phase 3 clinical trial showed that most patients (74 percent) experienced significantly improved chin projection for up to one year as measured by the Galderma Chin Retrusion Scale (GCRS). Positive aesthetic outcomes following treatment were demonstrated through high levels of subject satisfaction in FACE-Q and Global Aesthetic Improvement Scale (GAIS) questionnaires.

Belotero Balance(+) with Lidocaine Launches

Belotera Balance (+) with Lidocaine is launching in the US. Approved in 2011, Belotero Balance is an injectable filler used to smooth moderate-to-severe etched-in facial lines and wrinkles in the lower face.

“Belotero Balance has been a go-to filler for superficial lines for nearly 10 years, as its special HA formulation evenly blends with natural skin tissues, providing a flawless finish,” says New York City dermatologist Michelle Henry, MD. “Healthcare providers and patients now have the added value of a lidocaine formulation, with Belotero Balance(+).”