DAXI Demonstrates Positive Results in Phase 2 Study

January 7, 2021
Morgan Petronelli, Associate Editor

Revance Therapeutics announces positive results from its phase 2 multicenter, open-label study investigating DaxibotulinumtoxinA (DAXI) as an injectable treatment for glabellar lines, lateral canthal lines and dynamic forehead lines

Revance Therapeutics announces the results from its phase 2 multicenter, open-label study investigating DaxibotulinumtoxinA (DAXI) as an injectable treatment for glabellar lines, lateral canthal lines and dynamic forehead lines.

The study examined the efficacy of DAXI in 48 patients over 36 weeks, in which participants were given a single treatment of 40 units DAXI in the glabella, 32 units in the forehead and 48 units split between the lateral canthi.

At week 4, 100% of participants reported being “somewhat satisfied” with the treatment in all three areas using a 7-point Subject Global Satisfaction with Treatment Questionnaire. A total of 83%, 78.7% and 80.9% of participants reported being “very satisfied” with the treatment of their glabellar lines, forehead lines and lateral canthal lines, respectfully.

“Many of my patients are looking for a more enduring treatment of their upper facial lines and wrinkles, as currently available neuromodulators typically only last 10 to 16 weeks, depending on the location within the face,” says Jeffrey S. Dover, MD, FRCPC, study investigator and co-director of SkinCare Physicians in Chestnut Hill, Mass. “I am pleased to see the high patient satisfaction scores for DaxibotulinumtoxinA for Injection and expect a treatment regimen of just two times a year could be a welcome benefit to patients looking for long-lasting treatment.”

Investigators conclude DAXI is safe for injection and well-tolerated when used in the glabella, lateral canthi and forehead. The most common adverse events were injection site erythema (6.3%), facial discomfort (4.2%) and headache (2.1 %), and no treatment-related serious adverse events were reported.

The U.S. Food and Drug Administration (FDA) approval for DAXI was initially expected in November 2020. “Revance is currently awaiting a decision on the approval of DaxibotulinumtoxinA for Injection for the treatment of glabellar lines by the FDA, pending a manufacturing site inspection, which was delayed due to COVID-19 travel restrictions,” according to the release.

Full results of the study can be found at aestheticauthority.com