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New Galderma Phase IIIb Data Reinforce Rapid Onset and Long-lasting Aesthetic Improvement with RelabotulinumtoxinA

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
´º½ºÀÏÀÚ: 2025-02-18

ZUG, SWITZERLAND -- Galderma (SWX:GALD), the pure-play dermatology category leader, announced 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 molecule[3,4,5]. 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].

“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 period[1,7].

· Results supported a fast onset of aesthetic improvement at Day 1 (40%; subject-reported) and a duration of effect through 6 months[1].
· 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 12[1].
· 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 time[1].
· 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 events[1].

“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

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.



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