- Glabellar injection of DAXXIFY™ demonstrated a positive effect on eyebrow position -
- DAXXIFY™ demonstrated a high response rate and duration of effect ≥24 weeks across all age and race subgroups -
NASHVILLE, Tenn., September 19, 2022--(BUSINESS WIRE)--Revance Therapeutics, Inc. (Nasdaq: RVNC), a commercial stage biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced the publication of two peer-reviewed articles in Aesthetic Surgery Journal, the official journal of The Aesthetic Society. The publications reported the impact of DAXXIFY™ (DaxibotulinumtoxinA-lanm) for injection on brow position and frontalis muscle activity from a post-hoc analysis of patients in the Phase 2a forehead line (FHL) study and the SAKURA open-label safety (OLS) study as well as presenting the efficacy and safety of DAXXIFY™ analyzed by age and race based on a subgroup analysis of the SAKURA glabellar lines clinical trials.
"The newly released publications in the Aesthetic Surgery Journal showcase Revance’s commitment to generating novel data that helps healthcare providers more fully understand the clinical performance of DAXXIFY™," said Conor Gallagher, PhD, Vice President of Medical Affairs and Scientific Innovation at Revance. "This data demonstrates that treatment of frown lines with DAXXIFY™ results in an overall positive change in eyebrow position even with a modest reduction in forehead muscle activity."
Dr. Gallagher further stated, "The subgroup analysis displays a consistent duration of effect across adult patients of all ages and skin types, bolstering Revance’s commitment to advancing scientific research in a range of ethnic and diverse backgrounds."
The first publication evaluated the impact of glabellar injection of DAXXIFY™ on eyebrow position and frontalis activity. A post hoc analysis of patients from the Phase 2a FHL and SAKURA OLS studies, who received a single dose of DAXXIFY™ 40 Units to the glabella, showed a positive reduction in dynamic frontalis activity while maintaining or slightly lifting the eyebrows. Two weeks after treatment with DAXXIFY™ in glabellar lines, mild eyebrow elevation (at rest) was observed in the lateral, mid and medial brow regions. Further, a reduction in forehead skin compression (reflective of a reduction in frontalis muscle activity) was observed two weeks post DAXXIFY™ injection in glabellar lines with the greatest reduction in activity in the lower half of the frontalis.
A separate publication evaluated the efficacy and safety of DAXXIFY™ in the treatment of glabellar lines across age and race based on a subgroup-analysis of patients treated in the Phase 3 SAKURA clinical program. DAXXIFY™ demonstrated long-lasting efficacy in all subgroups, consistent with the overall population results of the SAKURA clinical trials. The analysis included 2,785 patients with moderate to severe glabellar lines who received their first dose of DAXXIFY™ (40 Units) in SAKURA 1, 2, or 3 and were evaluated for glabellar line severity for ≤36 weeks. Efficacy and safety were analyzed by age (18-45, >45-55, and >55 years) and race (Asian, Black/African American, and White). The proportion of patients achieving none or mild glabellar line severity at maximum frown based on Investigator Global Assessment–Frown Wrinkle Severity (IGA-FWS) rating after DAXXIFY™ treatment was high in all age and race subgroups (>96% at Week 4). Glabellar line severity of none or mild by composite IGA-FWS and Patient Frown Wrinkle Severity (PFWS) rating was maintained for a median of 24.0 weeks in all age subgroups, and 27.0, 25.3, and 24.0 weeks in the Asian, Black/African American, and White subgroups, respectively. The safety profile of DAXXIFY™ was consistent across the three main age (18-45, >45-55, and >55 years) and race subgroups, with headache and injection site reactions being the most commonly reported treatment-related treatment emergent adverse events (TEAEs) and treatment-related eyelid ptosis being reported in <2% of patients.
DAXXIFY™ (DaxibotulinumtoxinA-lanm) for injection is the first and only FDA approved long-lasting peptide-formulated neuromodulator product for use in adults for the temporary improvement of moderate to severe frown lines (glabellar lines).1-7 DAXXIFY™ has the ability to deliver year-long results for patients with potentially only two treatments per year and has been proven to be effective, and generally safe and well tolerated.2,8-10* DAXXIFY™ is powered by a cell-penetrating peptide technology (Peptide Exchange Technology™), Revance's proprietary, synthetic, 35-amino-acid stabilizing excipient with a highly positive charge, and is free of human serum albumin or animal-based components.1,2,7 Manufactured exclusively in the U.S., DAXXIFY™ is the first true innovation in neuromodulator product formulation in over 30 years.
Revance has evaluated this neuromodulator formulation in other Phase 2 clinical studies in aesthetics, including the full upper face, forehead lines and crow’s feet as well as in therapeutic indications, including cervical dystonia and upper limb spasticity. Learn more at RevanceAesthetics.com.
* At least 50% of patients treated with DAXXIFY™ in SAKURA 1 and 2 had none or mild frown lines per investigator or patient assessments for 24 weeks and 23.9 weeks (6 months) or longer (respectively) after treatment.
Please see DAXXIFY™ full Prescribing Information, including Boxed Warning and Medication Guide.
Revance is a commercial stage biotechnology company setting the new standard in healthcare with innovative aesthetic and therapeutic offerings that elevate patient and physician experiences. Revance’s aesthetics portfolio of expertly created products and services, including DAXXIFY™ (DaxibotulinumtoxinA-lanm) for injection, the RHA® Collection of dermal fillers, and OPUL®, the first-of-its-kind Relational Commerce platform for aesthetic practices, deliver a differentiated and exclusive offering for the company’s elite practice partners and their consumers. Revance has also partnered with Viatris Inc. to develop a biosimilar to BOTOX®, which will compete in the existing short-acting neuromodulator marketplace. Revance’s therapeutics pipeline is currently focused on muscle movement disorders including evaluating DaxibotulinumtoxinA for Injection in two debilitating conditions, cervical dystonia and upper limb spasticity.
"Revance" and the Revance logo and OPUL are registered trademarks of Revance Therapeutics, Inc.
Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.
BOTOX® is a registered trademark of Allergan, Inc.
Any statements in this press release that are not statements of historical fact, including statements related to the potential benefits, safety, efficacy and duration of DAXXIFY™; development of a biosimilar to BOTOX® with our partner, Viatris; statements about our business strategy, timeline and other goals, plans and prospects; and the outcomes for and experiences of patients; 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: our ability to successfully commercialize DAXXIFY™ and to continue to successfully commercialize the RHA® Collection of dermal fillers and OPUL®; the results, timing, costs, and completion of our research and development activities and regulatory approvals; our ability to obtain funding for our operations; the timing of capital expenditures; the accuracy of our estimates regarding expenses, future revenues, capital requirements, our financial performance and the economics of DAXXIFY™, the RHA® Collection of dermal fillers and OPUL®; 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, inspections 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 DAXXIFY™ and 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 DAXXIFY™, the RHA® Collection of dermal fillers, OPUL® and our drug product candidates, if approved; reports of adverse events or safety concerns involving DAXXIFY™ or the RHA® Collection of dermal fillers; 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 Hint, Inc; our ability to continue obtaining and maintaining intellectual property protection for DAXXIFY™ and our drug product candidates; the cost and our ability to defend ourselves in product liability, intellectual property, class action or other lawsuits; the volatility of our stock price; 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 our periodic filings with the Securities and Exchange Commission (SEC), including factors described in the section entitled "Risks Factors" on our Form 10-K filed with the SEC on February 28, 2022 and including, without limitation, our Form 10-Q for the quarter ended June 30, 2022, filed with the SEC on August 9, 2022. The forward-looking statements in this press release speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.
Data on File. Draft DAXXIFY™ Package Insert. Newark, CA: Revance Therapeutics, Inc, 2022.
Fabi SG, Cohen JL, et al. DaxibotulinumtoxinA for Injection for the treatment of glabellar lines: efficacy results from SAKURA 3, a large, open-label, phase 3 safety study. Dermatol Surg. 2020. doi:10.1097/DSS.0000000000002531
Xeomin. Prescribing Information. Merz Pharmaceuticals GmbH; 2020.
Dysport. Prescribing Information. Ipsen Biopharmaceuticals, Ltd; 2020.
Jeuveau. Prescribing Information. Evolus, Inc; 2020.
Botox Cosmetic. Prescribing Information. Allergan, Inc; 2020.
Waugh JM, Lee J, Dake MD, Browne D. Nonclinical and clinical experiences with CPP-based self-assembling peptide systems in topical drug development. Methods Mol Biol. 2011; 683:553
Carruthers JD, Fagien S, et al. DaxibotulinumtoxinA for Injection for the treatment of glabellar lines: results from each of two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2). Plast Reconstr Surg. 2020;145(1):45-58.
Bertucci V, Solish N, 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. 2020;82(4):838-845.
Green JB, Mariwalla K, Coleman K, 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. Dermatol Surg. 2020. doi:10.1097/DSS.0000000000002463
View source version on businesswire.com: https://www.businesswire.com/news/home/20220919005178/en/
Revance Therapeutics, Inc.:
Sara J. Fahy
Revance Therapeutics, Inc.:
Jessica Serra, 626-589-1007
Gilmartin Group, LLC.:
Laurence Watts, 619-916-7620