Glabellar (Frown) Lines — A
The FDA accepted for review the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection in the treatment of moderate to severe glabellar (frown) lines. The BLA under review includes results from three Phase 3 trials (SAKURA 1,2,3), the largest aesthetic neuromodulator clinical program ever conducted for the treatment of glabellar (frown) lines. DaxibotulinumtoxinA for Injection has also been evaluated in a Phase 2 head-to-head, active comparator study (BELMONT). DaxibotulinumtoxinA for Injection is an investigational agent that has not been approved by the FDA and is currently under regulatory review.
Forehead Lines — B
DaxibotulinumtoxinA for Injection is being evaluated in a Phase 2 open-label study for the treatment of moderate to severe dynamic forehead lines (frontalis) following glabellar line injection. An interim analysis from the study found that treatment with DaxibotulinumtoxinA for Injection substantially improved the appearance of forehead lines versus placebo at all doses tested 4 weeks after treatment and resulted in high patient satisfaction.3
Lateral Canthal Lines (Crow’s Feet) – C
DaxibotulinumtoxinA for Injection is being evaluated in a Phase 2 open-label study for the treatment of moderate to severe lateral canthal lines, commonly known as crow’s feet. Clinical data demonstrated positive efficacy results and that DaxibotulinumtoxinA for Injection was well tolerated.
Upper Facial Lines — A, B & C
Revance initiated a new open-label Phase 2 trial for treatment of the full upper face – glabellar (frown), lateral canthal (crow’s feet), and forehead lines combined – to understand the safety and efficacy, including potential dosing and injection patterns, of DaxibotulinumtoxinA for Injection. Topline results are anticipated in the fourth quarter of 2020.
For the latest information regarding our clinical development programs, please see our public filings with the Securities and Exchange Commission or visit clinicaltrials.gov.