One dose of RelabotulinumtoxinA significantly improves both frown lines and crow’s feet, when treated alone or simultaneously, and the results last for six months, according to research presented at the TOXINS 2024 International Conference in Berlin.
RelabotulinumtoxinA is a ready-to-use liquid botulinum toxin A which avoids the need to reconstitute from powder and eliminates variability, errors, and risks associated with such reconstitution. RelabotulinumtoxinA is currently under investigation by Galderma and is not approved for any indication in any jurisdiction.
The new data is part of the READY phase III clinical trial program. This program is composed of four phase III trials which enrolled more than 1,900 participants.
In READY-3, a phase III randomized, double-blind, placebo-controlled trial designed to assess the safety and efficacy, as measured by aesthetic improvement, of RelabotulinumtoxinA in patients with moderate to severe frown lines or crow’s feet, RelabotulinumtoxinA was administered as a single-area treatment or simultaneously on both frown lines and crow’s feet and compared to placebo.
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.
Investigator-reported response rates at one month were high, with 94-96% reporting none or mild frown lines when treated alone or simultaneously with crow’s feet, compared to placebo, and 79-84% reporting none or mild crow’s feet when treated alone or simultaneously with frown lines, compared to placebo, the study found. The median time of return to baseline 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.
Patient satisfaction was also high, with up to 91% reporting satisfaction with simultaneous treatment at one month. RelabotulinumtoxinA was well tolerated with low rates of treatment-related adverse events reported (4-9% compared to 5% for placebo); there were no serious treatment-related adverse events.
“These results build on those previously seen in the READY-1 and READY-2 trials, further reinforcing RelabotulinumtoxinA’s ability to provide long-lasting improvement for frown lines and crow’s feet when treated simultaneously,” says Baldo Scassellati Sforzolini, MD, PhD, the Global Head of R & D at Galderma, in a news release.
These results further reinforce the positive safety, efficacy, and long duration of effect data observed in the READY-1 and READY-2 trials, which – together with recent phase IIIB results – also demonstrated RelabotulinumtoxinA’s rapid onset of action on frown lines and crow’s feet as early as day 1.
Data from the READY-1 and READY-2 studies will also be presented at the TOXINS 2024 conference, highlighting that:
Both studies met their primary endpoints, with significantly higher responses than placebo after one month for both frown lines and crow’s feet.
Results showed rapid onset of action, with over a third of patients seeing results on day 1 for frown lines (39%) and crow’s feet (34%), and demonstrated long duration of effect for six months.
At the conference, Galderma will also present from the phase IV STAR study on Alluzience (abobotulinumtoxinA solution) for the treatment of frown lines.
In 81% of the treatment sessions, the investigators preferred Alluzience over onabotulinumtoxinA. The majority of patients maintained aesthetic improvement in frown lines and reported high satisfaction, including a natural and refreshed look, throughout six months.
In addition, results from a phase IV non-interventional study investigating the real-world use of Dysport (abobotulinumtoxinA) for the treatment of frown lines in 250 patients in China reinforced the long-term duration results and provided further evidence of Dysport use in clinical practice.
