Galderma’s phase III trial demonstrates efficacy of RelabotulinumtoxinA

Galderma has announced positive topline results from the phase III ‘READY-3’ clinical trial investigating the use of RelabotulinumtoxinA for the treatment of glabellar lines and lateral canthal lines, either alone or simultaneously.

1,900 people enrolled to participate in the READY clinical trial, composed of four phase III trials. READY-3 was a randomised, double-blind, placebo-controlled trial designed to assess the safety and efficacy, of RelabotulinumtoxinA in patients with moderate to severe frown lines or crow’s feet.

The trial met its co-primary endpoints, with patients and investigators reporting at least a two-grade improvement in line severity after single-area treatment of frown lines (71%), or crow’s feet (45%), and simultaneous treatment (72% frown lines and 55% crow’s feet), compared to placebo at one month (p<0.001).1

The median time of return to base line severity on both investigator- and patient-assessed scales was approximately six months after single-area (24-25 weeks) or simultaneous treatment (25-27 weeks), reinforcing previous results demonstrating the long duration of effect of RelabotulinumtoxinA.

Dr Vince Bertucci, past president of the American Society for Dermatologic Surgery (ASDS), says; “Patients often want their aesthetic look to last longer or to receive treatment on multiple facial areas simultaneously, and practitioners want to deliver consistent results for their patients.”

He continues; “Previous RelabotulinumtoxinA data proved it to be a convenient-to-use solution that rapidly and effectively improves frown lines and crow’s feet when treated individually. This new READY-3 trial data demonstrates its ability to be a durable solution when applied to both areas simultaneously, making it convenient for both aesthetics professionals and patients to achieve and maintain lasting desired outcomes.”

Data from the READY-1 and READY-2 studies will be presented at the TOXINS 2024 conference. RelabotulinumtoxinA is currently under investigation by Galderma and is not approved for any indication in any jurisdiction.

References

1. Bertucci V, et al. Efficacy and Safety of a Novel Formulation Liquid Botulinum Toxin, RelabotulinumtoxinA, when used for Combination Treatment of Glabellar and Lateral Canthal Lines. Abstract presented at TOXINS 2024.

UPDATE: 

Galderma has announced it will be sharing the latest updates from across its broad and unparalleled portfolio at the IMCAS World Congress 2024 in Paris February 1-3. Galderma’s events and activities at the congress will include three educational symposia, several ‘Meet the Expert’ sessions from across Galderma programs, ten research posters, interactive booth activities and more.