NEWARK, Calif.--(BUSINESS WIRE)--Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today announced three oral presentations and two ePosters at the American Society for Dermatologic Surgery (ASDS) Virtual Annual Meeting, October 9-11, 2020. Presented data will showcase 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.
“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,” said Roman Rubio, Senior Vice President of Clinical Development at Revance. “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.”
The first presentation will report 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 will highlight 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 will cover 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. These results were previously announced by Revance in June 2020.
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.
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.
Complete abstracts, details on presentation times and changes to presentation dates can be found on the ASDS website. The above listed dates are subject to change. Please check www.asds.net for the latest information.
About Revance Therapeutics, Inc.
Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow’s feet, as well as in three therapeutic indications - cervical dystonia, adult upper limb spasticity and plantar fasciitis. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Mylan N.V. to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team, visit us at www.revance.com.
“Revance Therapeutics” and the Revance logo are registered trademarks of Revance Therapeutics, Inc.
RHA resilient hyaluronic acid® and RHA® are trademarks of TEOXANE SA.
BOTOX® is a registered trademark of Allergan, Inc.
This press release contains forward-looking statements, including statements related to Revance’s financial outlook, milestone expectations, expected cash runway and financial performance; the planned commercial launch of our RHA® Collection of dermal fillers and the HintMD fintech platform, the process and timing of, and ability to complete, current and anticipated future clinical development of our investigational drug product candidates; the initiation, design, enrollment, submission, timing and results of our clinical studies, including the near-term milestone expectations described above; development of a biosimilar to BOTOX®; results of our non-clinical programs; statements about our business strategy, timeline and other goals and market for our anticipated products, plans and prospects, including our commercialization plans; statements about our ability to obtain, and the timing relating to, regulatory approval with respect to our drug product candidates, including with respect to the anticipated approval of DaxibotulinumtoxinA for Injection in glabellar lines and expected PDUFA date; and potential benefits of our drug product candidates and our technologies, including with respect to the RHA® line of dermal fillers and HintMD fintech platform.
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates, including our ability to receive timely approval of DaxibotulinumtoxinA for Injection; our ability to obtain funding for our operations; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; our ability to successfully commercialize our drug product candidates and the timing of commercialization activities and anticipated product launches; the rate and degree of market acceptance of our drug product candidates; our ability to develop sales and marketing capabilities; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, business operations, commercialization efforts, end user demand for our products, clinical trials and other aspects of our business. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in Revance's periodic filings with the Securities and Exchange Commission (the "SEC"), including factors described in the section entitled "Risks Factors" in the Registration Statement on Form 10Q filed with the SEC. The forward-looking statements in this press release speak only as of the date hereof. Revance disclaims any obligation to update these forward-looking statements.
“Revance Therapeutics” and the Revance logo are registered trademarks of Revance Therapeutics, Inc.
- Bertucci V, et al. “DaxibotulinumtoxinA for Injection has a prolonged duration of response in the treatment of glabellar lines: Pooled data from two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2).” J Am Acad Dermatol. 2019;82(4):838-845. doi: https://doi.org/10.1016/j.jaad.2019.06.1313
- Fabi SG, et al. “DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Efficacy Results From SAKURA 3, a Large, Open-Label, Phase 3 Safety Study.” Dermatologic Surgery. Published online August 6, 2020. doi: 10.1097/DSS.0000000000002531
- Green JB, et al. “A Large, Open-Label, Phase 3 Safety Study of DaxibotulinumtoxinA for Injection in Glabellar Lines: A Focus on Safety From the SAKURA 3 Study.” Dermatologic Surgery. Published online August 6, 2020. doi: 10.1097/DSS.0000000000002463
- Clinicaltrials.gov. “Efficacy and Safety of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines.” Available at: https://clinicaltrials.gov/ct2/show/NCT03911102?term=DaxibotulinumtoxinA.