Positive results in two phase III studies for a novel liquid formulation botulinumtoxin A (Relabotulinumtoxin A) for the treatment of glabellar lines (frown) and lateral canthal lines (crow’s feet).
Galderma announced topline results from two phase III clinical studies (NCT04249583, NCT04249687) demonstrating that Relabotulinumtoxin A, 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 six months.
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. READY-1 met its primary endpoint for participants with moderate-to-severe glabellar lines – the response to Relabotulinumtoxin A was significantly higher than placebo after one month (82.9% vs. 0%; P<0.001). In the trial, relabotulinumtoxin a had a rapid onset of effect (median 2 days, 39% of participants reported an effect on day 1) and the effects were long-lasting, persisting for up to six months. the median time to return to baseline severity was greater than 4 weeks (end of study).
Participant satisfaction with treatment was high for Relabotulinumtoxin A vs. placebo. At Month 1, 97% of participants were satisfied with the outcome of treatment and 86% remained satisfied at Month 6. Treated participants were also highly satisfied with how natural they looked (97% at Month 1, 88% at Month 6).
The second study, READY-2, was a multicenter randomized,double-blind, placebo-controlled, phase III trial of Relabotulinumtoxin A for the treatment of moderate-to-severe lateral canthal lines (crow’s feet). Results from the six-month study, involving 303 participants, showed that treatment with Relabotulinumtoxin A improved lateral canthal lines, with high participant satisfaction and a rapid onset of effect.READY-2 met its primary endpoint with the response among those participants receiving treatment significantly higher than placebo (51.8% vs. 1.4%, P<0.001). The onset of effect was rapid (median 2 days, 34% of participants reported onset of effect by day 1) and the effect was long-lasting, up to six months. the median time to return to baseline severity was 173 days (24.7 weeks).
Safety and tolerability profile :In both studies, RelabotulinumtoxinA was well tolerated. All treatment-related adverse events were mild-to-moderate, non-serious and transient. In READY-1, 3.6% of treated participants (0%, placebo) experienced a treatment-related adverse event; the most common was headache. In READY-2, treatment-related adverse events occurred in 6.1% of treated participants (5.5%, placebo) and the most common was injection-site bruising.
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