READY-4: Sustained and Safety Efficacy of RelabotulinumtoxinA

Key Takeaways:

• Long-term safety and efficacy of RelabotulinumtoxinA confirmed over 12 months in the phase III READY-4 trial.
• Efficacy maintained across multiple treatments, with high patient satisfaction reported throughout.
• These updated data were presented at the American Society for Dermatological Surgery 2024 Annual Meeting.

New results from the phase III READY-4 trial presented at the 2024 ASDS Annual Meeting demonstrate the long-term safety and sustained efficacy of Galderma’s RelabotulinumtoxinA (Relfydess™) for the treatment of moderate-to-severe frown lines and crow’s feet.

The multicenter, open-label READY-4 trial included more than 900 participants, receiving injections at least 12 weeks apart over four cycles. According to Galderma, the study results were fully consistent with previous data from the READY-1, -2, and -3 studies. The majority of patients experienced mild or no wrinkle severity at one month post-treatment, and there was consistently high patient satisfaction (84%). Safety was maintained over four treatment cycles across 12 months. The researchers reported there were mild to moderate treatment-related adverse events in 18% of participants, while efficacy remained high throughout. 

“These data add to the already extensive evidence base showcasing the potential benefits of RelabotulinumtoxinA," said Dr. Kenneth Beer, MD, a READY-4 trial investigator, dermatologist, and founder of Beer Dermatology and Cosmetic Bootcamp, in a press release. "Having demonstrated long-term safety, as well as ease of use, sustained results, and an onset of action as early as day one, RelabotulinumtoxinA has the potential to influence the neuromodulator space by addressing and going beyond current treatment limitations, for both physicians and our patients.”  

Dr. Baldo Scassellati Sforzolini, Global Head of R&D at Galderma, emphasized the significance of these results.

“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," he said in a news release from the manufacturer. 

Source: Galderma press release. Oct. 21, 2024.