Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company developing botulinum toxin products for use in treating aesthetic and therapeutic conditions, today announced the electronic publication (ePub) of its completed BELMONT Phase 2 trial results in the peer-reviewed journal, Dermatologic Surgery. Positive 24-week results for BELMONT, a Phase 2 active comparator, double-blinded, placebo-controlled, multi-center trial of DaxibotulinumtoxinA for Injection (RT002) for the treatment of glabellar (frown) lines, were first announced in October 2015.

“The BELMONT trial results are exciting, in that they show RT002 injectable could be the first new generation botulinum toxin treatment offering patients higher response rates and a longer duration of response without compromising safety or tolerability”


  • SAFETY: All dose levels of RT002 appeared to be generally safe and well-tolerated.
  • EFFICACY: When compared to placebo, all dose levels of RT002 achieved highly statistically significant efficacy at Week 4 (p < 0.001) based on investigator and patient reporting. When compared to 20U of onabotulinumtoxinA (BOTOX* Cosmetic/VISTABEL*), the 40U dose of RT002 showed statistical and clinical superiority over onabotulinumtoxinA for a range of efficacy outcomes, as rated by investigators, for none or mild and 1- and 2-point improvement in glabellar wrinkle severity.
    • Response Rate: The proportion of subjects with glabellar line severity rated by investigators as none or mild with 40U of daxibotulinumtoxinA was more than double – and significantly greater than that with 20U of onabotulinumtoxinA at weeks 16 and 24 (67% vs 32% at Week 16 {p=0.002} and 31% vs. 12% at Week 24 {p=0.041}, respectively), according to the Investigator Global Assessment- Facial Wrinkle Severity (IGA-FWS) score at maximum frown. Similarly, the proportion of subjects rated by investigators as improved per the Global Aesthetic Improvement Scale (GAIS) at 16 and 24 weeks was greater for 40U of daxibotulinumtoxinA than 20U of onabotulinumtoxinA (97% vs 81% at Week 16 {p<0.05} and 44% vs. 19% at Week 24 {p<0.05}, respectively).
    • Duration: The median duration of response (at least a 1-point improvement for baseline in IGA-FWS score at maximum frown) was longer with daxibotulinumtoxinA (20.0, 23.6 and 20.9 weeks for 20U, 40U and 60U, respectively) than for onabotulinumtoxinA (18.8 weeks) or placebo (0.0 weeks) (p< .001 for all botulinum toxins vs placebo and p=.030 for daxibotulinumtoxinA 40U vs onabotulinumtoxinA).