Evolus announces results from European head-to-head filler trial
Evolus Inc, provided its data presented at IMCAS during its Earnings conference call on March 7.
Evolus remains on track for the global commercial launch of the first-generation Cold HA Technology in 2025. The filler line will be branded Evolysse in the US and Estyme in the UK and Europe. The Estyme Lift filler will be positioned as the most versatile and highest volume filler in the product line. Lift is CE Marked in Europe and will be filed with the FDA in the summer of 2024 with approval expected in 2025.
The European Lift study was blinded, randomized, nine months in duration, and enrolled 45 patients. The study was a split face design, in which each patient received Estyme Lift on one side and the control, Restylane-L, on the other side. Using a validated five-point scale, the change in Nasolabial Fold (NLF) severity from baseline was measured. The primary endpoint of non-inferiority was met at four weeks, with the results favouring Estyme Lift, and at three and six months, Estyme Lift achieved statistical superiority over Restylane-L. The safety profiles were similar and there were no treatment-related serious adverse events.
“The Evolysse/Estyme product line is the first filler made with the proprietary Cold-HA manufacturing process which is designed to better preserve the natural structure of the HA molecule, the building block for the entire line of fillers,” said Dr Rui Avelar, chief medical officer and head of research and development. “These clinical data are supportive of the robustness of the technology platform, and we look forward to the anticipated European approval for the four Estyme products later this year, as well as the first two US approvals in the Evolysse line in 2025.”
In 2023 Evolus entered into two agreements with Symatese to be the exclusive distributor of a novel dermal filler line in late-stage development, the first agreement for the United States under the brand name Evolysse and the second agreement for the United Kingdom and Europe under the brand name Estyme. As a result of these agreements, the company has increased its addressable market by 78% to approximately £4.8 billion ($6 billion).