Galderma's RelabotulinumtoxinA Smooths Glabellar, Lateral Canthal Lines

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. 

Galderma’s novel liquid formulation botulinumtoxinA (RelabotulinumtoxinA) performed well for the treatment of glabellar lines and lateral canthal lines, according to new research presented at the Vegas Cosmetic Surgery & Aesthetic Dermatology meeting.

RelabotulinumtoxinA is a ready-to-use liquid botulinum toxin A with a proprietary strain and manufactured via 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. 

Topline results from two phase III clinical studies (NCT04249583, NCT04249687) demonstrating that RelabotulinumtoxinA improves both glabellar and lateral canthal lines with a rapid onset of action and a long duration up to six months.

Both studies met their primary endpoint, demonstrating a significant ≥2-grade composite improvement (as assessed by both subject and investigator) in glabellar line severity and lateral canthal line severity vs. placebo at Month 1, with rapid onset of action and up to six-month duration of action. 

The first clinical study, READY-1, was a multicenter, randomized, double-blind, placebo-controlled, phase III trial of RelabotulinumtoxinA for the treatment of moderate-to-severe glabellar lines (frown lines) in 300 participants followed for six months.1 Results from READY-1 showed that RelabotulinumtoxinA significantly reduced glabellar line severity and was well tolerated.

READY-1 met its primary endpoint for participants with moderate-to-severe glabellar lines – the response to RelabotulinumtoxinA was significantly higher than placebo after one month (82.9% vs. 0%; P<0.001).

In the trial, RelabotulinumtoxinA 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 >24 weeks (end of study).

Participant satisfaction with treatment was high for RelabotulinumtoxinA vs. placebo. At Month 1, 97 percent of participants were satisfied with the outcome of treatment and 86 percent 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 RelabotulinumtoxinA 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 RelabotulinumtoxinA 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).

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 percent 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 percent of treated participants (5.5%, placebo) and the most common was injection-site bruising.