First results from the phase III READY-4 trial demonstrate the long-term safety of repeated injections of RelabotulinumtoxinA for both frown lines and crow’s feet, with efficacy and patient satisfaction maintained across multiple treatments1
These results were presented alongside additional data from the phase III READY clinical trial program showing RelabotulinumtoxinA’s long duration of effect for six months for frown lines and crow’s feet2,3
Data presented add to the body of evidence demonstrating the safety and efficacy of RelabotulinumtoxinA, including its onset of action as early as day one4,5
Developed and manufactured by Galderma, RelabotulinumtoxinA is the first and only ready-to-use liquid neuromodulator developed using PEARL Technology that is optimized for simple volumetric dosing to increase ease-of-use6-8
Further update on neuromodulators: the International Chamber of Commerce (ICC) reaffirmed the scope of Galderma’s exclusive distribution rights with respect to Azzalure and Dysport and Galderma’s rights to commercialize these products in additional countries in Eastern Europe and Central Asia, following the completion of arbitration proceedings in October 2024
ZUG, Switzerland--(BUSINESS WIRE)--Galderma today announced new phase III data from the READY-4 clinical trial, demonstrating the long-term safety of RelabotulinumtoxinA (Relfydess™) for frown lines and crow’s feet after repeated injections.1 The READY-4 study met its primary and secondary endpoints, with less than one in five participants experiencing treatment-related treatment-emergent adverse events (TEAEs), and all events deemed mild or moderate.1 Efficacy and patient satisfaction were also maintained across multiple treatments.1 The data were presented at the American Society for Dermatologic Surgery (ASDS) 2024 Annual Meeting, held in Florida from October 17-20.
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.6-8 Previously announced data from the READY clinical trial program have demonstrated that up to 39% of patients see effects from day one and up to 75% of patients maintain improvements for six months for frown lines and crow’s feet when treated with RelabotulinumtoxinA.4,5,9
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“As RelabotulinumtoxinA is the first neuromodulator to be developed and manufactured by Galderma, we’re proud to be able to share more data from our READY clinical program. These READY-4 data demonstrate RelabotulinumtoxinA’s consistent safety and efficacy profile with repeated injections over a year, supporting its potential to be a safe, effective, and durable treatment for both frown lines and crow's feet.”
BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D. GLOBAL HEAD OF R&D GALDERMA
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