Galderma is officially launching its ready-to-use liquid toxin relabotulinumtoxinA (Relfydess) in Europe.

The launch took place at the IMCAS World Congress 2025 in Paris, France. RelabotulinumtoxinA is approved in 14 European countries for relaxing glabellar and canthal lines. It is the first neuromodulator to receive simultaneous approval for these two indications in Europe.

The neuromodulator also has marketing authorization from Australia’s Therapeutic Goods Administration and the Medicines and Healthcare Products Regulatory Agency in the UK. In the U.S., Galderma received a Complete Response Letter related to its Biologics License Application for relabotulinumtoxinA from the federal Food and Drug Administration that pointed out certain deficiencies isolated to items related to Chemistry, Manufacturing, and Controls (“CMC”) processes. Galderma is currently working with the FDA to resolve the relevant issues.

The European launch is further supported by new data from the Phase IIIb RELAX clinical trial that was presented at IMCAS. The study reinforced the fast, high, and sustained efficacy of a single treatment of relabotulinumtoxinA for moderate to severe glabellar lines beyond 6 months.

Specifically, relabotulinumtoxinA had a fast onset of action, with results visible at Day 1. In addition, nearly 70% of patients achieved high and sustained satisfaction with treatment outcomes and appearance beyond 6 months, and 60% were still satisfied with the results at 12 months.

Furthermore, at both Month 6 and Month 12, more than 50% of subjects reported that they had increased self-confidence and looked great for their age, the study showed.

Ready-to-use Toxin

No reconstitution is necessary with relabotulinumtoxinA, allowing for more consistent results. The neuromodulator was created with PEARL Technology to preserve molecule integrity and deliver a highly active, innovative, complex-free molecule.

Christian Merkel, MD, a dermatologist in Munich, Germany, was the first physician to use relabotulinumtoxinA in late 2024. “What do patients want? Fast onset and sustained results,” he says at a media briefing.

The toxin is optimized for simple volumetric dosing to increase ease of use. There is also no need to count units with relabotulinumtoxinA, which allows the provider to spend more time with the patient, he says.

“We go beyond by hitting on all the targets and needs that patients are looking for,“ says Gerry Muhle, Galderma’s Head of Global Product Strategy.

The new data backs up results from the Phase III READY clinical trial program, which demonstrated rapid onset as soon as Day 1 (reported by up to 39% of subjects) and long-lasting efficacy for 6 months (maintained by up to 75% of subjects) when using RelabotulinumtoxinA to treat frown lines and lateral canthal lines.