Galderma’s wrinkle treatment, RelabotulinumtoxinA, reduced wrinkles in participants with minimal side effects in two phase III clinical studies.
Galderma announced topline results from two phase III clinical studies demonstrating that RelabotulinumtoxinA, a novel liquid formulation botulinum toxin A, improves both glabellar and lateral canthal lines with a rapid onset of action and a long duration up to 6 months.
RelabotulinumtoxinA is a highly-active, complex-free liquid botulinum toxin A with a proprietary strain and manufactured using a unique process.
RelabotulinumtoxinA is designed as a liquid, avoiding the traditional requirement to reconstitute from powder, eliminating variability, errors and risks associated with reconstitution, which would be expected to improve the consistency of results.
The READY (Relabotulinumtoxin Aesthetic Development Study) phase III clinical program is composed of four phase III clinical trials which enrolled more than 1,900 participants.
Both studies met their primary endpoints with significantly higher response than placebo after one month for both frown lines and crow’s feet.
Results showed rapid onset of action with median response within 2 days with 39% seeing results on Day 1 for frown lines and 34% on Day 1 for crow’s feet.
The results also lasted up to six months after treatment with high satisfaction from treated participants in the study.
In both studies, RelabotulinumtoxinA was well tolerated and all treatment-related adverse events were mild-to-moderate, non-serious and transient, according to Galderma.
“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 that offers consistency in results for frown lines and crow’s feet, which can have a significant impact on patients’ self-esteem and well-being,” said Baldo Scassellati Sforzolini, MD, global head of research and development for Galderma. “We are looking forward to submitting the data to U.S. and global authorities as part of the next step in bringing this potential, new treatment to patients.”