The primary endpoint analysis showed that 73.8% of DAXI patients but only 0.5% of controls achieved a two-point composite response at week 4. The responder rate in the DAXI group was the same whether patients had moderate or severe glabellar lines at baseline. At week 4, 97.5% of subjects were rated as None or Mild by the investigator, and 91.1% when rated by the subjects at the 24-week follow-up visit. The median time to return of baseline severity was approximately 27 weeks.
The incidence of eyelid ptosis associated with DAXI in SAKURA 1 and 2 was 2.2%.
DAXI has unique characteristics compared with other neuromodulators that are approved for aesthetic use. Although all of the products contain the same 150 kDa core neurotoxin protein (botulinum toxin type A), unlike onabotulinumtoxinA (Botox Cosmetic) and abobotulinumtoxinA (Dysport), DAXI is highly purified and free of accessory proteins. In contrast to both the latter two competitors and incobotulinumtoxinA (Xeomin), DAXI is formulated with a patented stabilizing peptide excipient and is free of animal-derived components and human serum albumin.
Revance Therapeutics submitted a Biologics License Applications to the FDA for DAXI in the treatment of moderate-to-severe glabellar lines in November 2019.
Dr. Fabi is an investigator for Allergan, Croma, Galderma, Merz, and Revance and has stock in Allergan and Revance.