RelabotulinumtoxinA Shows Long-Term Safety and Efficacy in Phase III Trial for Facial Lines
核心洞察
Galderma's RelabotulinumtoxinA (Relfydess™) demonstrates sustained safety and efficacy in treating frown lines (搜索) and crow's feet with repeated injections over 12 months.
The Phase III READY-4 trial met its primary and secondary endpoints, showing high patient satisfaction and a low incidence of mild to moderate adverse events.
Data supports RelabotulinumtoxinA as a durable treatment option, with many patients maintaining improvements and satisfaction throughout multiple treatment cycles.
Galderma announced positive Phase III results from the READY-4 clinical trial, evaluating RelabotulinumtoxinA (Relfydess™) for treating moderate-to-severe frown lines (搜索) and crow’s feet (搜索). The study, presented at the American Society for Dermatologic Surgery (ASDS) 2024 Annual Meeting, demonstrated the long-term safety and maintained efficacy of the neuromodulator with repeated injections.
The READY-4 trial, a multicenter, open-label study, involved over 900 participants receiving up to four injection cycles over 12 months, spaced at least 12 weeks apart. The study met its primary and secondary endpoints, with less than 20% of participants experiencing treatment-related adverse events, all of which were mild to moderate. Efficacy was sustained, with most participants achieving none-or-mild wrinkle severity one month post-treatment, maintained across multiple cycles. Patient satisfaction remained high, with ≥84% satisfaction reported one month after each treatment.
Consistent Safety Profile
The safety profile of RelabotulinumtoxinA in the READY-4 trial was consistent with previous Phase III READY-1, -2, and -3 trials. Treatment-emergent adverse events (TEAEs) were mild to moderate, reported by 18% of participants, with similar occurrence across treatment cycles (11%, 7%, 7%, and 10% in cycles one, two, three, and four, respectively).
Sustained Efficacy and Patient Satisfaction
Efficacy was maintained throughout the 12-month study, with most participants achieving none-or-mild wrinkle severity one month after treatment. High treatment satisfaction was also reported, with ≥84% of participants satisfied at one month post-treatment.
Expert Commentary
"These data add to the already extensive evidence base showcasing the potential benefits of RelabotulinumtoxinA," said Dr. Kenneth Beer, READY-4 clinical trial investigator. "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."
About RelabotulinumtoxinA
RelabotulinumtoxinA, pioneered by Galderma, is the first ready-to-use liquid neuromodulator created with PEARL™ Technology, designed to preserve molecule integrity. This technology aims to deliver a highly active, innovative, complex-free molecule. Clinical data has shown effects as early as day one in up to 39% of patients, with up to 75% maintaining improvements for six months. The formulation is optimized for simple volumetric dosing without reconstitution, enhancing ease of use and ensuring consistent dose/volume.
Additional Data Presented at ASDS
Additional data presented at ASDS included:
- READY-3 study data demonstrating significant improvement in both frown lines and crow’s feet, whether treated alone or simultaneously, with long duration of effect, a favorable safety profile, and high patient satisfaction.
- Pooled data from READY-1, -2, and -3 studies showing similarly high rates of improvement for both frown lines and crow’s feet across different skin types, ethnicities, and races, affirming its efficacy and safety across diverse populations.
Galderma's Broader Portfolio
RelabotulinumtoxinA expands Galderma's neuromodulator portfolio as part of its Injectable Aesthetics offerings. Galderma is working to launch RelabotulinumtoxinA in approved markets in the first half of 2025.