Evolus Announces Results from European Head-to-Head Filler Trial
- Evolysse™/Estyme® Lift demonstrated statistical superiority over Restylane-L in improving nasolabial fold severity
- The European Lift study achieved the primary endpoint of non-inferiority
- Evolysse™/Estyme® Lift will be launched globally in 2025 under different brand names
- The filler line is positioned as versatile and high-volume, with CE Mark in Europe and FDA filing expected in 2024
- The study showed no serious adverse events with similar safety profiles
- The proprietary Cold-HA manufacturing process preserves the natural structure of the HA molecule
- None.
Insights
From a medical research standpoint, the announcement from Evolus regarding the statistical superiority of their dermal filler product over Restylane-L is significant. It indicates that the Evolysse™/Estyme® Lift product has potentially improved efficacy in treating nasolabial fold severity, a common aesthetic concern. The proprietary Cold-HA manufacturing process mentioned could represent a substantial advancement in filler technology by preserving the natural structure of hyaluronic acid (HA), which is crucial for maintaining skin hydration and elasticity.
The study's design, being blinded and randomized with a split-face approach, adds credibility to the results. However, it is essential to note that the sample size of 45 patients might be considered small and further research with larger populations may be necessary to confirm these findings. The safety profile being similar to Restylane-L is also encouraging, as it suggests no increased risk associated with the new product.
From a market perspective, the introduction of Evolus's new product line could disrupt the current aesthetic market dynamics. The claim of the Evolysse™/Estyme® Lift being the most versatile and highest volume filler in their product line could attract a significant customer base, especially if the product delivers on its promise of longevity and stable outcomes.
The strategic distribution agreements with Symatese to become the exclusive distributor in the United States and Europe are critical moves that expand Evolus's addressable market by 78% to approximately $6 billion. This expansion could substantially impact Evolus's market share and revenue growth, particularly if the Evolysse™/Estyme® Lift gains FDA approval and is successfully commercialized in 2025. The company's forward-looking statements about the global commercial launch and FDA filing timeline demonstrate confidence in their product and strategic planning.
Analyzing the financial implications, Evolus's announcement is poised to have a positive impact on the company's stock market performance, contingent upon successful commercialization and market adoption. The data's inclusion in the upcoming earnings call suggests that the company views this as a significant milestone with potential to influence investor sentiment. The exclusive distribution agreements and the expansion of the addressable market are likely to be viewed favorably by investors, as they represent growth opportunities.
However, investors should be mindful of the risks involved, including the possibility of delays or issues in obtaining FDA approval, challenges in market penetration against established competitors and the need for substantial marketing efforts to promote the new product line. It will be vital for investors to monitor the company's progress towards these goals and evaluate the potential return on investment based on the product's performance in clinical trials and its subsequent market reception.
- 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
- The European Lift study met the primary endpoint of non-inferiority
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
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
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About Evolus, Inc.
Evolus (Nasdaq: EOLS) is a performance beauty company evolving the aesthetic neurotoxin market for the next generation of beauty consumers through its unique, customer-centric business model and innovative digital platform. Our mission is to become a global, multi-product aesthetics company based on our flagship product, Jeuveau® (prabotulinumtoxinA-xvfs), globally licensed under the brand name Nuceiva®. The product is manufactured in a state-of-the-art facility using Hi-Pure™ technology. Evolus is expanding its product portfolio having entered into a definitive agreement to be the exclusive
Jeuveau®, Nuceiva®, and Evolysse™ are trademarks of Evolus, Inc.
Hi-Pure™ is a trademark of Daewoong Pharmaceutical Co, Ltd.
Estyme® is a trademark of Symatese Aesthetics S.A.S.
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Investors:
Nareg Sagherian, Vice President, Head of Global Investor Relations and Corporate Communications
Phone: (248) 202-9267
Email: ir@evolus.com
Media:
Email: media@evolus.com
Source: Evolus
FAQ
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