Revance Therapeutics Inc, a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, presented three oral presentations and two ePosters at the American Society for Dermatologic Surgery (ASDS) Virtual Annual Meeting, held October 9-11, 2020.

Presented data showcased novel findings from the SAKURA Phase 3 program evaluating DaxibotulinumtoxinA for Injection for the treatment of moderate or severe glabellar (frown) lines, as well as a 4-week interim analysis from the Phase 2a open-label study for the treatment of moderate to severe lateral canthal lines (LCL), commonly known as crow’s feet lines, according to the company in a news release.

“These data underscore the potential of DaxibotulinumtoxinA for Injection to set a new standard in facial aesthetics treatments and advance our mission of transforming the patient experience.

“The data from the LCL study were used to optimize our Phase 2 open-label upper facial lines study, which we expect to report results from in the fourth quarter of 2020. Additionally, these findings support our overarching scientific platform as we continue to establish a new category of long-lasting neuromodulator products for our prestige aesthetics portfolio.”

— Roman Rubio, Senior Vice President of Clinical Development at Revance

The first presentation reported on the efficacy, duration, and safety of DaxibotulinumtoxinA for Injection in females across multiple age cohorts following the treatment of glabellar lines in the SAKURA program. This subgroup analysis demonstrated that the efficacy and duration of DaxibotulinumtoxinA for Injection for the treatment of glabellar lines is similarly high in adult females independent of age.

The second presentation highlighted details from the SAKURA program in which DaxibotulinumtoxinA for Injection treated subjects showed substantial and progressive improvement in the severity of glabellar lines at rest following repeated treatment.

The final presentation covered 4-week interim data from the Phase 2a open-label study in crow’s feet. Data demonstrated that following treatment of LCLs with DaxibotulinumtoxinA for Injection, 88% of subjects achieved a score of none or mild at Week 4 in at least one treatment group. DaxibotulinumtoxinA for Injection appeared to be well tolerated at all dose levels.

Oral Presentations

  • DaxibotulinumtoxinA for Injection Demonstrates Consistent Efficacy, Duration, and Safety in Females Independent of Age: Subgroup Analysis from a Large, Phase 3 Program
    Friday, October 9, 2020, 9:36 a.m. – 9:39 a.m. ET during the Session #1: Oral Abstracts.
    Presenter: Glynis Ablon, M.D., FAAD, Dermatologist at Ablon Skin Institute and Research Center, Manhattan Beach, CA, and Associate Clinical Professor at University of California, Los Angeles, CA, USA
  • DaxibotulinumtoxinA for Injection–treated subjects show progressive improvement in static glabellar lines with repeated treatment
    Friday, October 9, 2020, 9:42 a.m. – 9:45 a.m. ET during the Session #1: Oral Abstracts.
    Presenter: Richard Glogau, M.D., Dermatologist at Glogau Dermatology, San Francisco, CA, and Clinical Professor of Dermatology University of California, San Francisco, CA, USA
  • DaxibotulinumtoxinA for Injection for Lateral Canthal Lines: A 4-week Interim Analysis
    Friday, October 9, 2020, 9:39 a.m. – 9:42 a.m. ET during the Session #1: Oral Abstracts.
    Presenter: Terrence Keaney, M.D., FAAD, Dermatologist at SkinDC Cosmetic Center, Arlington, VA, Assistant Clinical Faculty of Dermatology at George Washington University and Howard University, and Director of the Laser and Lipoatrophy Clinic at the Veterans Affairs Hospital, Washington, D.C.

ePosters:

  • Rheological Evaluation of the Dynamic Properties of Hyaluronic Acid-based Dermal Fillers
    Authors: Vince Bertucci, Conor Gallagher, Jimmy Faivre, Kevin Legent, Mélanie Gallet, Elodie Tremblais, François Bourdon
    Affiliations: University of Toronto, Toronto, Ontario, Canada and private practice, Woodbridge, Ontario, Canada; Revance Therapeutics, Inc., Newark, California; Teoxane, Geneva, Switzerland
  • Evaluation of the Impact of Hyaluronic Acid (HA) Filler Manufacturing Technologies on HA Chain Degradation
    Authors: Jay Mashburn, Jimmy Faivre, François Bourdon
    Affiliations: Revance Therapeutics, Inc., Newark, California; Teoxane, Geneva, Switzerland

Revance is anticipating the U.S. Food and Drug Administration (FDA) approval of DaxibotulinumtoxinA for Injection in glabellar (frown) lines in the fourth quarter of this year and is generating additional data in facial aesthetics, including three Phase 2 open-label trials in lateral canthal (crow’s feet), upper facial lines and forehead lines.

The open-label Phase 2 trial of DaxibotulinumtoxinA for Injection for the treatment of upper facial lines – glabellar (frown), lateral canthal (crow’s feet), and forehead lines combined – completed enrollment in February 2020, and the company expects to report topline results in the fourth quarter of 2020, it notes in the release.

[Source(s): Revance Therapeutics Inc, Business Wire]


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