NEWARK, Calif.--(BUSINESS WIRE)--Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company developing next-generation neuromodulators for use in treating aesthetic and therapeutic conditions, today announced podium and poster presentations of its SAKURA 3 Phase 3 open-label, long-term safety study of DaxibotulinumtoxinA for Injection (DAXI) for the treatment of glabellar (frown) lines at the 17th Aesthetics & Anti-Aging Medical World Congress (AMWC). The leading international conference was held April 4 - 6 in Monte-Carlo, Monaco. SAKURA 3 was the culmination of the largest aesthetic clinical program of an aesthetic neuromodulator, which consistently demonstrated unprecedented efficacy, safety and duration across 65 sites and 3,800 treatments. The SAKURA 3 trial was specifically designed to evaluate the long-term safety of DAXI following both single and repeat treatment administration in adults 18 years of age and over.
“I was excited to present the SAKURA 3 study data on DAXI at the largest aesthetics meeting in the world, with more than 2,000 people in attendance,” said cosmetic dermatologic surgeon Sabrina Guillen-Fabi, MD, of Cosmetic Laser Dermatology in San Diego, Calif. “Colleagues were impressed with the consistent and predictable response rates, the safety profile and, most importantly, the duration of effect.”
SAKURA 3 Podium Presentation
Results of a large open-label safety study of DaxibotulinumtoxinA for Injection in glabellar lines (Session: Botulinum Toxin: From Fundamental to Expert Practice).
Presenter: Dr. Sabrina Guillen-Fabi
SAKURA 3 Poster Presentation
Results of a large open-label safety study of DaxibotulinumtoxinA for Injection in glabellar lines
Sabrina Guillen-Fabi, MD, Jeremy B Green, MD, Yan Liu, Roman G Rubio, Conor J Gallagher
SAKURA 1 and 2 Pivotal Phase 3 Trial Poster Presentation
Pooled results from two Phase 3 pivotal studies of DaxibotulinumtoxinA for Injection in glabellar lines
Joely Kaufmann-Janette, MD, Nowell Solish, MD, Yan Liu, Roman G Rubio, Conor J Gallagher
"We were delighted to have Dr. Sabrina Guillen-Fabi share the exceptional results from the SAKURA 3 trial with a worldwide audience of aesthetic and anti-aging experts," said Dan Browne, president and chief executive officer at Revance. “We will continue to share these results at aesthetics conferences and through major medical journals while we await potential U.S. regulatory approval next year. Revance plans to launch DAXI as not only a premium product, but the first major innovation in neuromodulators in 30 years, delivering enduring frown line reduction with just two treatments a year.”
About Revance Therapeutics, Inc.
Revance Therapeutics is an emerging Silicon Valley biotechnology leader developing neuromodulators for the treatment of aesthetic and therapeutic conditions. Revance uses a unique proprietary peptide excipient technology to create novel, differentiated therapies. The company’s lead compound, DaxibotulinumtoxinA for Injection (DAXI), is in clinical development for a broad range of aesthetic and therapeutic indications, including glabellar lines, cervical dystonia, plantar fasciitis, upper limb spasticity and chronic migraine. DAXI has the potential to be the first long-acting neuromodulator. The company is advancing a robust pipeline of injectable and topical formulations of daxibotulinumtoxinA. More information on Revance may be found at www.revance.com.
"Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.
This press release contains forward-looking statements, including statements related to Revance Therapeutics' current and anticipated future clinical development and potential commercialization of our investigational drug product candidates, including DAXI; statements about our business strategy, timeline and other goals and market for our anticipated products, plans and prospects; including our pre-commercialization plans and commercial potential of our client candidates; and statements about the benefits of, and our ability to obtain regulatory approval with respect to our drug product candidates and our excipient peptide and other technologies.
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, or that positive results would assure regulatory approval or commercial success of our product candidates; our ability to obtain and maintain regulatory approval of our drug product candidates; 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; 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 other risks. 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 "Risk Factors" of our annual report on Form 10-K filed February 28, 2019. These forward-looking statements speak only as of the date hereof. Revance disclaims any obligation to update these forward-looking statements.