Pharmaceutical company Galderma has released the results of its two phase III studies for its liquid formulation of botulinumtoxinA (relabotulinumtoxinA).
The results, which were announced at the Vegas Cosmetic Surgery & Aesthetic Dermatology meeting, demonstrated that relabotulinumtoxinA improves both glabellar and lateral canthal lines. The READY phase III clinical programme comprised of four phase III clinical trials, which enrolled more than 1,900 participants.
The first trial, READY-1, investigated the treatment of moderate-to-severe glabellar lines in 300 participants who were followed for six months. Participant satisfaction was also high for relabotulinumtoxinA vs placebo. At month one, 97% of participants were satisfied with the outcome of treatment and 86% remained satisfied at month six. Treated participants were also highly satisfied with how natural they looked (97% at month one, 88% at month six). The second study, READY-2 investigated the treatment of moderate-to-severe lateral canthal lines.
In both studies, the toxin was well tolerated with only 3.6% of participants in READY-1 experiencing a treatment-related adverse event; the most common was a headache. In READY-2, adverse events occurred in 6.1% and the most common was injection-site bruising.
Dr Baldo Scassellati Sforzolini, global head of research and development at Galderma, said, “We developed this innovative neuromodulator to respond directly to the needs of healthcare professionals and the expectations of patients who are looking for a safe, effective, long-lasting treatment. We wanted to offer consistency in results for frown lines and crow’s feet, which can have a significant impact on patients’ self-esteem and wellbeing.”