GALDERMA
Galderma today announced that it has completed its European decentralized procedure (DCP), resulting in a positive decision for RelfydessTM (RelabotulinumtoxinA – previously referred to as QM1114). RelfydessTM is indicated for the temporary improvement in the appearance of moderate-to-severe glabellar lines (frown lines) at maximum frown and lateral canthal lines (crow’s feet) seen at maximum smile, alone or in combination, in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient.9 Following the successful completion of the DCP, national approvals in the 16 concerned countries are now under finalization. RelfydessTM also received a marketing authorization in Australia earlier this year.
RelfydessTM is developed and manufactured by Galderma. It is the first and only ready-to-use liquid neuromodulator created with PEARL™ Technology that is designed to preserve molecule integrity to deliver a highly active, innovative, complex-free molecule, with up to 39% of patients seeing effects from day one and up to 75% of patients maintaining improvements for six months for frown lines and crow’s feet.3,4,7,8 It is optimized for simple volumetric dosing, without reconstitution, to increase ease of use and help ensure consistent dose/volume.1,10
“With RelfydessTM, Galderma is introducing a highly differentiated and innovative neuromodulator, reinforcing our leadership and strong growth in this field, and our commitment to developing and delivering the broadest portfolio in Injectable Aesthetics. As per the decentralized European approach, our teams are now finalizing the approval procedures at the country level, so we’re ready to launch in multiple markets early next year.”
FLEMMING ØRNSKOV, M.D., MPH, CHIEF EXECUTIVE OFFICER GALDERMA
|
This positive decision, and the previous Therapeutic Goods Administration approval in Australia, were based on results from the phase III READY (RElabotulinumtoxin Aesthetic Development StudY) clinical trial program, which enrolled more than 1,900 participants. Results showed:3,4,7,8
-
Improvement in both frown lines and crow’s feet versus placebo:
- In READY-1 and READY-2, treatment with RelfydessTM demonstrated a 96.3% none-or-mild responder rate for frown lines and 87.2% for crow’s feet, after one month, vs 4.5% and 11.9% for placebo, respectively.
-
Onset of action as soon as day one:
- In READY-1 and READY-2, 39% of patients reported improvements for frown lines and 34% reported improvements for crow’s feet from day one.
-
Sustained results for six months:
- In READY-1 and READY-2, up to 75% of patients maintained improvements for six months.
- At month one, up to 96% achieved none-or-mild frown lines and crow’s feet, which was sustained for six months in almost a quarter of patients.
- Patient satisfaction was maintained for six months following treatment.
“With the growing need for new innovations in the neuromodulator space, I’m excited that, with RelfydessTM, we have a new treatment that delivers both fast and sustained results in a simple and convenient formulation, so we can achieve the desired outcomes for our patients quickly, effectively, and without compromise.”
DR. SACHIN SHRIDHARANI LEAD INVESTIGATOR OF READY-1 TRIAL PLASTIC SURGEON AND FOUNDER OF LUXURGERY
|
Regulatory applications for Relfydess™ for the treatment of frown lines and crow’s feet will continue to be submitted and assessed by additional authorities globally.
About RelfydessTM (RelabotulinumtoxinA)
Pioneered by Galderma, RelfydessTM is the first and only ready-to-use liquid neuromodulator created with PEARLTM Technology that is designed to preserve molecule integrity.1,2 PEARLTM Technology is designed to deliver a highly active, innovative, complex-free molecule, with up to 39% of patients seeing effects from day one and up to 75% of patients maintaining improvements for six months.1-4,7,8 RelfydessTM is optimized for simple volumetric dosing, without reconstitution, to increase ease-of-use and help ensure consistent dose/volume every time.1,10 It was entirely developed and manufactured by Galderma to expand its neuromodulator portfolio as part of the broadest Injectable Aesthetics portfolio on the market.
About the READY clinical trial program
The READY (RElabotulinumtoxin Aesthetic Development StudY) phase III clinical program is composed of four phase III clinical trials which enrolled more than 1,900 participants.3-6 The READY trials investigated the safety, efficacy, rapidity of onset and/or durability of RelfydessTM for six months on:
- Frown lines (READY-1).3
- Crow’s feet (READY-2).4
- Frown lines and crow’s feet when treated alone or simultaneously (READY-3).5
- Frown lines and crow’s feet when treated alone or simultaneously with up to four repeated injections over 52 weeks (READY-4).6
About Galderma
Galderma (SIX: GALD) is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.
References:
- Sundberg AL and Stahl U. Relabotulinum toxin - a novel, high purity BoNT-A1 in liquid formulation. Presented at: TOXINS 2021; Jan 16-17, 2021; virtual meeting
- Do M, et al. Purification process of a complex-free highly purified botulinum neurotoxin type A1 (BoNT-A1) - relabotulinumtoxinA. Presented at: TOXINS 2022; July 27-30, 2022; New Orleans, LA
- Galderma. Data on file. Clinical Study Report for Protocol 43QM1602: READY-1. Galderma Laboratories; 2021
- Galderma. Data on file. Clinical Study Report for Protocol 43QM1901: READY-2. Galderma Laboratories; 2021
- Galderma. Data on file. Clinical Study Report for Protocol 43QM1902: READY-3. Galderma Laboratories; 2021
- Galderma. Data on file. Clinical Study Report for Protocol 43AM1903: READY-4. Galderma Laboratories; 2021
- Shridharani SM, et al. Efficacy and Safety of RelabotulinumtoxinA, a New Ready-to-Use Liquid Formulation Botulinum Toxin: Results From the READY-1 Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial in Glabellar Lines. Aesthetic Surgery Journal. 2024; sjae131
- Ablon G, et al. Treatment of Lateral Canthal Lines with RelabotulinumtoxinA, an Investigational Liquid Botulinum Toxin: Clinical Efficacy and Safety Results from the READY-2 Phase III Trial. Abstract presented at TOXINS 2024; Jan 17-20, 2024, Berlin
- Relfydess® EU Summary of Product Characteristics
- Persson C, et al. Patient and Investigator Treatment Experience with Ready-to-Use AbobotulinumtoxinA Solution Versus Powder BotulinumtoxinA for Treatment of Glabellar Lines. Abstract presented at TOXINS 2024; Jan 17-20, 2024, Berlin
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240729848736/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
SII Begins Mass Production of the World’s Smallest (1.0 × 0.8 × 0.32mm) Tuning-Fork Crystal Resonator “SC-10S”9.12.2025 03:00:00 CET | Press release
Achieving Both a 33% Reduction in Mounting Area and Low ESR Seiko Instruments Inc. (President: Yoichi Endo; Headquarters: Chiba City, Chiba Prefecture; hereinafter “SII”) will begin mass production of the “SC-10S” (32.768kHz), the world’s smallest* tuning-fork crystal resonator measuring 1.0 × 0.8mm, starting in April 2026. *Based on SII research as of November 2025. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251202800779/en/ Product Image-1 [Background of Development] SII has already been mass-producing the “SC-12S” (32.768kHz), one of the world’s smallest tuning-fork crystal resonators at 1.2 × 1.0mm. As wearable devices such as smart rings and smartwatches, as well as IoT devices, continue to become smaller, the electronic components built into these devices are increasingly required to support high-density mounting, low power consumption, and high performance. To meet these needs, SII leveraged its proprietary photol
Verimatrix: Signing of an Agreement for the Sale of XTD Assets (Code and Application Protection) to Guardsquare8.12.2025 17:45:00 CET | Press release
Sale of XTD assets (mobile application protection) including a portfolio of patents and a team of experts for an initial offer of $8.5m, the final price will be adjusted at the closing.Verimatrix refocuses on Anti-Piracy (video protection), the group's core business representing approximately 90% of its total revenue Regulatory News: VERIMATRIX (Euronext Paris: VMX, FR0010291245), a leading provider of user security solutions for a safer connected world, announces the signing of an agreement with Belgium-based Guardsquare, the leading provider of mobile application security, for the sale of its Extended Threat Defense (XTD) assets. Guardsquare, the creators of the open-source optimization tool, ProGuard, offers the most complete mobile application security platform on the market spanning automated testing and multi-layered protection, real time threat monitoring, and app attestation. Guardsquare’s 975+ customers are located in more than 95 countries and represent all major industries.
WNBA Champion Sabrina Ionescu Becomes Global Brand Ambassador for Ant International8.12.2025 17:00:00 CET | Press release
Four-time WNBA All-Star Sabrina Ionescu today becomes a new Global Brand Ambassador for Ant International, a leading global provider of digital payments, digitisation, and financial technology. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251208536426/en/ The partnership is built on a shared commitment to creating a more inclusive and sustainable world through empowering underserved communities and youth groups with sports and technology innovation. It marks an important step in Ant International’s journey to foster growth and expand access to financial tools through innovative technology. Ionescu serves as the first Ant International global brand ambassador from North America. “Sabrina embodies the spirit of perseverance and the passion for excellence that is driving young talents and small businesses around the world to uplift their communities,” said Douglas Feagin, President of Ant International. “As a legend in a spor
SABCS 2025: REVEAL GENOMICS Presents Major Advance in Predicting Brain Metastasis in HER2+ Breast Cancer8.12.2025 16:20:00 CET | Press release
The new HER2DX central nervous system (CNS) progression score predicts risk of brain progression in advanced HER2+ breast cancer, addressing a major unmet need in identifying patients at the highest risk of CNS involvement. During SABCS 2025, the company presents a total of 7 studies with 1,300 tumor samples analyzed, covering HER2-positive, ER-negative, and triple-negative breast cancer (TNBC), representing one of the largest and most comprehensive genomic data contributions to the symposium. New clinical evidence includes superior pCR prediction compared with TILs, demonstration of real-time genomic testing feasibility in an international trial, and validation of RNA-based ERBB2 assessment to accelerate clinical decision-making. REVEAL GENOMICS, S.L., a Barcelona-based biotechnology company focused on advancing precision oncology through biomarker innovation, announced today the presentation of seven studies at the upcoming San Antonio Breast Cancer Symposium (SABCS) 2025, held Decem
NetApp Advances EMEA & LATAM Presence with Appointment of Willem Hendrickx as Customer Demand for AI Accelerates8.12.2025 16:15:00 CET | Press release
A leader in driving enterprise transformation, Hendrickx brings nearly three decades of experience, strengthening global partner ecosystems and customer relationships across regions NetApp (NASDAQ: NTAP), the intelligent data infrastructure company, today announced the appointment of Willem Hendrickxas Senior Vice President and General Manager, EMEA & LATAM, effective January 5, 2026. Hendrickxwill lead NetApp’s business strategy, go-to-market execution, and partner engagement across Europe, the Middle East, Africa, and Latin America. Reporting to NetApp President César Cernuda, Hendrickx brings a deep regional knowledge and track record of building high-performing teams, further enabling the acceleration of NetApp’s international footprint by helping global customers navigate the evolving demands of hybrid cloud and AI-driven data infrastructure. Hendrickx holds a Master’s degree in Applied Economics from KU Leuven and is based in Brussels, Belgium. “Willem joins NetApp at a pivotal t
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom