Swiss skincare company Galderma has reported positive data from a Phase III clinical trial of RelabotulinumtoxinA (Relfydess) for treating moderate-to-severe frown lines and crow’s feet.
The multicentre, open-label READY-4 trial assessed the safety of RelabotulinumtoxinA for the long-term treatment of moderate-to-severe frown lines and crow’s feet.
Go deeper with GlobalData
The study involved more than 900 participants, who received treatments at a minimum of 12 weeks apart, with up to four cycles over a 12-month period.
The trial met all its primary and secondary endpoints, while the results also confirmed the long-term safety of repeated RelabotulinumtoxinA injections, matching with the safety profile observed in the previous Phase III READY-1, READY-2 and READY-3 trials.
Treatment-related, treatment-emergent adverse events were reported by 18% of participants, with all events considered mild or moderate in severity.
Efficacy was also sustained throughout the trial, with most participants achieving little to no wrinkle severity one month after treatment.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataThis outcome was maintained across all treatment cycles throughout the year.
In addition, participant satisfaction with the treatment remained high, with at least 84% expressing satisfaction one month after treatment.
RelabotulinumtoxinA is a ready-to-use liquid neuromodulator that uses PEARL Technology to maintain molecule integrity.
The product received a positive decision after completing its European decentralised procedure earlier this year, while approvals for it in the US are currently being finalised.
Galderma global research and development head Baldo Scassellati Sforzolini said: “As RelabotulinumtoxinA is the first neuromodulator to be developed and manufactured by Galderma, we’re proud to be able to share more data from our READY clinical programme.
“These READY-4 data demonstrate RelabotulinumtoxinA’s consistent safety and efficacy profile with repeated injections over a year, supporting its potential to be a safe, effective, and durable treatment for both frown lines and crow’s feet.”
In July last year, Galderma announced positive results from the Phase III trial of nemolizumab, its drug candidate for prurigo nodularis.
