Revance to Present Clinical Data on DaxibotulinumtoxinA for Injection and Hyaluronic Acid Filler Injection Technique at the 2021 American Society for Dermatologic Surgery (ASDS) Virtual Annual Meeting
- Two presentations highlighting data on DaxibotulinumtoxinA for Injection, including one oral presentation showcasing new data on clinical immunogenicity from the SAKURA Phase 3 program, and one abstract on injection technique for midface volumization with hyaluronic acid based fillers -
“We look forward to sharing a breadth of data at this year’s ASDS Virtual Annual Meeting, including new data on DaxibotulinumtoxinA for Injection in glabellar lines and a novel injection technique for midface volumization with hyaluronic acid fillers,” said
The first oral presentation will report on new data from the SAKURA Phase 3 trials evaluating the immunogenic potential of DaxibotulinumtoxinA for Injection in the treatment of glabellar lines, with repeated drug administration. A second oral presentation presents a new pooled responder analysis from the SAKURA 1 and 2 glabellar lines studies and introduces a novel method of visualizing the results.
An e-poster presents an optimized injection technique for midface volumization, appropriate for dynamic Hyaluronic Acid based fillers.
- Title: Clinical Immunogenicity of DaxibotulinumtoxinA for Injection in Glabellar Lines Including Subjects With Multiple Exposures: Pooled Data from the SAKURA Phase 3 Trials
Authors and Affiliations:
Shannon Humphrey, University of British Columbiaand Humphrey Cosmetic Dermatology, Vancouver, British Columbia, Canada; Jeffrey S. Dover, SkinCare Physicians, Chestnut Hill, MA; Ronald R. Bowsher, Amanda Clancy, B2S Life Sciences, Franklin, IN; Yan Liu, Conor J. Gallagher, Revance Therapeutics, Inc., Nashville, TN
- Title: Visualizing the Elimination of Glabellar Lines Following Treatment With DaxibotulinumtoxinA for Injection
Authors and Affiliations:
Shannon Humphrey, University of British Columbiaand Humphrey Cosmetic Dermatology, Vancouver, British Columbia, Canada; Sabrina Fabi, Cosmetic Laser Dermatology, San Diego, CA; Derek Jones, Skin Careand Laser Physicians of Beverly Hills, Beverly Hills, CA; Todd Gross, Yan Liu, Roman Rubio, Revance Therapeutics, Inc., Nashville, TN
- Title: Midface volumization: A multilayering injection technique for soft tissue hyaluronic acid fillers designed for dynamic facial movement
Authors and Affiliations:
Hassan Galadari, College of Medicine and Health Sciences, United Arab Emirates University, Al Ain, UAE; Susan H. Weinkle, Private practice, Bradenton, FLand University of South Florida, Tampa, FL; Jay Mashburn, Revance Therapeutics, Inc., Nashville, TN
The above presentations will be live for the duration of the ASDS virtual conference and also available on-demand for 60 days post-meeting. Complete abstracts, details on presentation times and changes to dates can be found on the ASDS website. Please check www.asds.net for the latest information.
Revance 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
“Revance Therapeutics” and the Revance logo are registered trademarks of
Resilient Hyaluronic Acid® and RHA® are trademarks of
BOTOX® is a registered trademark of
Any statements in this press release that are not statements of historical fact, including statements related to novel injection technique; our ability to set a new standard in facial aesthetic treatments; innovation in facial aesthetic treatments; our product pipeline growth; the potential benefits of DaxibotulinumtoxinA for Injection and the RHA® Collection of dermal fillers; differentiation of our products; development of a biosimilar to BOTOX®; and statements about our business strategy, timeline and other goals, plans and prospects, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements will ever be achieved or occur.
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties relate, but are not limited to: the results, timing, costs, and completion of our research and development activities and regulatory approvals, including our ability to obtain a Type A meeting with the FDA, remediate deficiencies identified by the FDA, obtain FDA approval of the BLA for DaxibotulinumtoxinA for Injection for the treatment of glabellar lines, including as a result of observations made by the FDA during the site inspection or other reasons; the timing of capital expenditures; the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, end user demand for our products and services, the aesthetics market, commercialization efforts, business operations, regulatory meetings and approvals, clinical trials and other aspects of our business and on the market; our ability and the ability of our partners to manufacture supplies for our product candidates and to acquire supplies of the RHA® Collection of dermal fillers; the uncertain clinical development process; the risk that clinical trials may not have an effective design or generate positive results or that positive results would assure regulatory approval or commercial success; the applicability of clinical study results to actual outcomes; the rate and degree of economic benefit, safety, efficacy, commercial acceptance, market, competition and/or size and growth potential of the RHA® Collection of dermal fillers, OPUL™ and our drug product candidates, if approved; our ability to continue to successfully commercialize the RHA® Collection of dermal fillers and OPUL™ and our ability to successfully commercialize DaxibotulinumtoxinA for Injection, if approved, and the timing and cost of commercialization activities; the proper training and administration of our products by physicians and medical staff; our ability to expand sales and marketing capabilities; the status of commercial collaborations; changes in and failures to comply with privacy and data protection laws; our ability to effectively manage our expanded operations in connection with the acquisition of