Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection, today announced results for two Phase 2a open-label, dose escalation studies of its investigational drug candidate DaxibotulinumtoxinA for Injection in the treatment of dynamic forehead lines (FHL) following glabellar (frown) line injections and lateral canthal lines (LCL), commonly known as crow’s feet. The company announced that both studies demonstrated positive efficacy results and that DaxibotulinumtoxinA for Injection was well tolerated. Additionally, the studies evaluated a range of doses and while not powered to provided clinical significance, they provided directional guidance on the impact of dose on efficacy and duration of effect.
In the forehead lines study, a total of 61 subjects were randomized into one of four dose groups with each receiving 40 units of DaxibotulinumtoxinA for Injection in the glabellar complex, followed two weeks later by injections of either 12, 16, 24, or 30 units in the forehead for a total study duration of up to 38 weeks. In the crow’s feet study, a total of 63 patients were randomized into one of four dose groups to receive either 12, 24, 36 or 48 units of DaxibotulinumtoxinA for Injection, then followed for up to 36 weeks.