Galderma has announced new Phase III data from the READY-4 clinical trial, showcasing the long-term safety and efficacy of RelabotulinumtoxinA (Relfydess™) for treating frown lines and crow’s feet after repeated injections. The study met its primary and secondary endpoints, revealing that fewer than 20% of participants experienced treatment-related adverse events, all classified as mild or moderate. Efficacy and patient satisfaction were consistently maintained throughout multiple treatments. The data were presented at the 2024 American Society for Dermatologic Surgery (ASDS) Annual Meeting in Florida.
Developed with PEARL™ Technology, RelabotulinumtoxinA is the first ready-to-use liquid neuromodulator designed to preserve molecular integrity for optimal effectiveness. Previous results from the READY clinical trial program indicated that up to 39% of patients experienced effects from day one, with 75% maintaining improvements for six months.
Dr. Biao He, CEO of Galderma, stated, “These READY-4 data reinforce RelabotulinumtoxinA’s safety and efficacy profile with repeated injections, highlighting its potential as a durable treatment for frown lines and crow’s feet.”
The READY-4 trial involved over 900 participants and was designed to assess the long-term safety of RelabotulinumtoxinA, with injections administered at least 12 weeks apart over 12 months. The results confirmed the safety profile seen in earlier Phase III trials, with mild to moderate adverse events reported by 18% of participants across treatment cycles.
Efficacy was also sustained, with most participants achieving none or mild wrinkle severity at one month, and high treatment satisfaction rates (≥84%) were reported.
Dr. Kenneth Beer, a clinical trial investigator, noted, “These findings add to the substantial evidence supporting the benefits of RelabotulinumtoxinA, which addresses and surpasses current treatment limitations for both physicians and patients.”
Additional data presented at ASDS included findings from the Phase III READY-3 study, which demonstrated significant improvements in frown lines and crow’s feet with long-lasting effects, and a post-hoc analysis showing consistent efficacy across diverse skin types and ethnicities.
Galderma has recently completed its European decentralized procedure for RelabotulinumtoxinA, leading to a positive decision, and is finalizing national approvals. The product received marketing authorization in Australia earlier this year, with plans for global regulatory applications continuing.
In an update on ongoing legal matters, Galderma concluded its arbitration with Ipsen concerning distribution rights for Azzalure® and Dysport® under their 2007 agreement. The ICC tribunal reaffirmed Galderma’s exclusive distribution rights in several countries but denied monetary compensation related to the timing of those rights. Galderma and Ipsen remain committed to growing sales of Azzalure® and Dysport® within their partnership.
