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Evolus dermal filler product (Evolysse™/Estyme® Lift) demonstrates statistical superiority at 3 and 6 months compared to Restylane-L with respect to improvement in nasolabial fold severity
Evolus, Inc. (NASDAQ:EOLS), a performance beauty company with a focus on building an aesthetic portfolio of consumer brands, today announced that it will provide the data presented at IMCAS during its upcoming Earnings conference call on March 7th at 4:30 p.m. ET.
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 Evolysse™/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, 9 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 5-point scale, the change in Nasolabial Fold (NLF) severity from baseline was measured. The primary endpoint of non-inferiority was met at 4 weeks, with the results favoring Estyme® Lift, and at 3 and 6 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, MD, Chief Medical Officer and Head of R&D. "Lift represents one of the first Evolysse™ fillers that we will introduce in the US, and we believe this data is supportive of the performance benefits of the technology."
"As the lead investigator in the US NLF trial, I have had first-hand experience injecting Evolysse™ Lift," said Dr. Michael Kaminer, MD. "The product is extremely versatile and forgiving, with the unique property of being injectable at various depths in the skin. Post injection recovery was rapid, and the product has a nice ability to retain a 1:1 correction, providing both longevity and stable outcomes. The natural quality of the post-treatment aesthetic results with Evolysse™ Lift are impressive."
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 $6 billion.
Posted In: EOLS
