- First results from the phase IIIb RELAX clinical trial reinforce the high and sustained efficacy of single treatment of RelabotulinumtoxinA (RelfydessTM) for moderate to severe frown lines (glabellar lines) beyond 6 months
- These results reinforce RelabotulinumtoxinA’s 6-month clinical effect and rapid onset from Day 1 demonstrated in the phase III READY clinical trial program1,2
- Data also show high and sustained patient satisfaction with treatment outcomes and appearance beyond 6 months1
- Developed and manufactured by Galderma, RelabotulinumtoxinA is the first and only ready-to-use liquid neuromodulator developed using PEARLTM Technology that is optimized for simple volumetric dosing to increase ease-of-use3,4,5
ZUG, Switzerland -- (BUSINESS WIRE) --
Galderma (SWX:GALD), the pure-play dermatology category leader, announced today results from its new phase IIIb RELAX clinical trial demonstrating the rapid onset and the long-lasting duration of aesthetic efficacy, as well as high patient satisfaction and increased confidence, using a single-dose of RelabotulinumtoxinA (Relfydess) to treat frown lines (glabellar lines)1. Galderma’s analysis was presented at the International Master Course on Aging Science (IMCAS) 2025 annual congress, held in Paris from January 30 to February 1, 2025.
Developed and manufactured by Galderma, RelabotulinumtoxinA 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 molecule3,4,5. Previously announced data from the phase III READY clinical trial program demonstrated rapid onset as soon as Day 1 (reported by up to 39% of subjects) and long-lasting efficacy for 6 months (maintained by up to 75% of subjects) when using RelabotulinumtoxinA to treat frown lines and crow’s feet (lateral canthal lines) 2,6.
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“We are proud to share our latest RelabotulinumtoxinA data, which reaffirms the sustained clinical effect and patient satisfaction observed in our READY clinical trial program. These findings, together with our proprietary PEARL Technology, reinforce RelabotulinumtoxinA as a safe, effective, and innovative treatment option, and uphold Galderma’s position at the forefront of aesthetic advancements.” BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D. GLOBAL HEAD OF R&D GALDERMA |
RELAX is a phase IIIb, multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the long-lasting efficacy and satisfaction of RelabotulinumtoxinA in 132 adults with moderate-to-severe frown lines over a 12-month period1,7.
- Results supported a fast onset of aesthetic improvement at Day 1 (40%; subject-reported) and a duration of effect through 6 months1.
- Subject satisfaction with treatment and appearance was also high, with 92% of subjects satisfied with treatment outcome at Month 1, 69% satisfied at Month 6, and 60% still satisfied at Month 121.
- Furthermore, at both Month 6 and at Month 12, more than 50% of subjects reported that they had increased self-confidence and looked great for their age, highlighting sustained benefits of RelabotulinumtoxinA over time1.
- Investigators reported high rates of ≥1-grade improvement from baseline, with the highest responder rates at Month 1 (98%), and improvement in GL severity maintained through Month 6 (57%) and Month 9 (28%). RelabotulinumtoxinA continues to be well tolerated with no treatment-related serious adverse events1.
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“I’m excited to see the continued benefits of RelabotulinumtoxinA highlighted in the RELAX study, in my practice. With onset from Day 1 coupled with sustained efficacy and high satisfaction for 6 months, healthcare professionals will be able to address a real need from patients, by offering them the fast acting and long-lasting results they desire, in an easy-to-use liquid formulation, with two treatments a year.” GLYNIS ABLON, M.D., F.A.A.D. ASSOCIATE CLINICAL PROFESSOR UNIVERSITY OF CALIFORNIA, LOS ANGELES
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Following the successful completion of the European Decentralized Procedure, resulting in a positive decision for the use of Relfydess (RelabotulinumtoxinA), Galderma already received national approvals in 14 European countries, as well as a marketing authorization from Australia’s Therapeutic Goods Administration and the Medicines and Healthcare products Regulatory Agency in the UK.
More details on Galderma’s scientific presentations at IMCAS can be found here.
About RelabotulinumtoxinA
Pioneered by Galderma, RelabotulinumtoxinA is the first and only ready-to-use liquid neuromodulator created with PEARL Technology that is designed to preserve molecule integrity4,5. PEARL 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 6 Months3,4,5,6. RelabotulinumtoxinA is optimized for simple volumetric dosing, without reconstitution, to increase ease-of-use and help ensure consistent dose/volume every time4,5. 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 Galderma
Galderma (SIX: GALD) is the 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:
1 Prather HB, et al. Efficacy and safety of a novel formulation liquid botulinum toxin, RelabotulinumtoxinA, when used for combination treatment of glabellar and lateral canthal lines. E-poster presented at: ASDS 2024; October 17-20, 2024; Orlando, FL
2 Ibrahim SF, et al. RelaBoNT-A treatment of glabellar lines and lateral canthal lines across different ethnicity and race: Pooled data from three phase III studies. E-poster presented at: ASDS 2024; October 17-20, 2024; Orlando, FL
3 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
4 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
5 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
6 Based on a literature search conducted in May 2023 across PuBMED, clinicaltrials.gov, and euDRACT
7 Galderma. Data on file. Clinical Study Report for Protocol QM111: RELAX. Galderma Laboratories