Baldo Scassellati Sforzolini, MD, PhD, MBA, Galderma’s global head of research, recently presented data on RelabotulinumtoxinA, a neuromodulator effective for six months in wrinkle treatment. The READY-4 trial confirms its safety and efficacy, with PEARL Technology ensuring consistent results across diverse patient groups. Here, Sforzolini shares his findings.
Plastic Surgery Practice: How does the safety profile of RelabotulinumtoxinA in the READY-4 trial compare with previous neuromodulators used for frown lines and crow’s feet?
Baldo Scassellati Sforzolini, MD, PhD, MBA: These 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 treatments. These data build on the results from the READY-1-3 studies, in which RelabotulinumtoxinA also demonstrated a favorable safety profile and a low incidence of treatment-related adverse events.
As the first neuromodulator developed and manufactured by Galderma, RelabotulinumtoxinA adds to the growing body of evidence supporting its safety and efficacy. We are proud to contribute to the latest innovations in aesthetics, reaffirming our commitment to bringing the best advancements to the market.
PSP: What factors ensure RelabotulinumtoxinA’s six-month efficacy in the READY trial? How does its day-one onset enhance patient outcomes?
Sforzolini: In the neuromodulator space, patients seek fast and sustained results, and healthcare professionals look for longer-lasting, more convenient, and ready-to-use solutions. RelabotulinumtoxinA is optimized for simple volumetric dosing, without reconstitution, to increase ease of use and help ensure consistent dosing. It is the first and only ready-to-use liquid neuromodulator created with PEARL™ Technology, designed to preserve molecule integrity to deliver fast and sustained results for frown lines and crow’s feet.
In READY-1 and READY-2, 39% of patients reported improvements for frown lines and 34% reported improvements for crow’s feet from day one. In READY-1, 75% of patients maintained improvements for six months, as measured by a Kaplan-Meier analysis of the time to return to baseline on both the investigator and subject scales. At month one, up to 96% achieved no or mild frown lines and crow’s feet, which was sustained for six months in almost a quarter of patients.
PSP: Could you explain the role of PEARL Technology in preserving the molecule integrity of RelabotulinumtoxinA?
Sforzolini: Precipitation-free Extraction and Activity-Preserving Refined Liquid (PEARL™) Technology is a pioneering approach proprietary to Galderma and has been over 15 years in the making, designed to preserve the power and natural form of the core molecule.
This advanced technology, with a unique multi-step purification process, eliminates precipitation and freeze-drying steps associated with traditional methods, keeping the core molecule in a liquid state throughout. It is designed to carefully remove complexing proteins and impurities while preserving RelabotulinumtoxinA’s potency and natural structure, aiming to optimize both activity and purity to produce a highly active formulation containing only the essentials.
PSP: What were the key findings from the post-hoc analysis showing RelabotulinumtoxinA’s efficacy across diverse populations in the READY-1, -2, and -3 studies?
Sforzolini: Pooled data from a post-hoc analysis of the READY-1, -2, and -3 studies showed similarly high rates of improvement for both frown lines and crow’s feet following treatment with RelabotulinumtoxinA across different skin types, ethnicities, and races. The treatment was also well tolerated in all subgroups.
These data add to the robust body of evidence demonstrating the efficacy and safety of RelabotulinumtoxinA, reinforcing its effectiveness across diverse populations and highlighting its potential to advance the neuromodulator space by addressing and surpassing current treatment limitations.
References:
- Galderma. Data on file. Clinical Study Report for Protocol 43QM1602: READY-1. Galderma Laboratories; 2021Galderma.
- Data on file. Clinical Study Report for Protocol 43QM1901: READY-2. Galderma Laboratories; 2021
- Shridharani SM, et al. Efficacy and Safety of RelabotulinumtoxinA, a New Ready-to-Use Liquid Formulation Botulinum Toxin: Results From the READY-1 Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial in Glabellar Lines. Aesthetic Surgery Journal. 2024; sjae131
- Ablon G, et al. Treatment of Lateral Canthal Lines with RelabotulinumtoxinA, an Investigational Liquid Botulinum Toxin: Clinical Efficacy and Safety Results from the READY-2 Phase III Trial. Abstract presented at TOXINS 2024; Jan 17-20, 2024, Berlin
