Evolus Announces Positive Data from Pivotal Trial for First Two Evolysse™ Dermal Filler Products at 2024 SCALE Meeting
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Evolus -
Evolus dermal filler, Evolysse™ Smooth, met primary endpoint of non-inferiority and demonstrated superiority to Restylane-L at 6 months; Secondary endpoints for improvement in nasolabial fold severity showed statistically significant differences compared to Restylane-L at 6 and 9 months - The safety profiles were similar between the two Evolysse™ dermal filler products and Restylane-L and there were no treatment-related serious adverse events
- On track to submit Premarket Approval (PMA) applications for the first two Evolysse™ dermal filler products with the FDA within the next 90 days
“Achieving positive topline results in our NLF study is a pivotal step supporting the upcoming submission of our Premarket Approval application for the
“Built on the earlier success of the European head-to-head trial, the consistency of results from this pivotal trial for Evolysse™ Lift and Smooth were impressive when compared to the previously shared European nasolabial fold data,” said Dr.
“As an investigator in this pivotal trial, I had first-hand experience in treating patients with the new Evolysse™ HA filler line that is manufactured using a novel “Cold Technology” process which is aimed at preserving the natural structure of the HA molecule,” said Dr.
Study Design
The
The 6-month primary endpoint measured the change in NLF severity from baseline and was assessed by a blinded independent photographic review panel using a validated 5-point nasolabial scale.
Results
The Evolysse™ Lift vs Restylane-L arm met the primary endpoint of non-inferiority and demonstrated superiority, with a mean NLF severity score difference of -0.3 (95% CI: -0.500, -0.032, non-inferiority margin 0.5) and corresponding p-value of 0.03. As a secondary endpoint, the mean grade change in the NLF severity, as assessed by the blinded, live evaluator demonstrated a statistically significant difference (p<0.05) at all timepoints from 6 weeks to 12 months between Evolysse™ Lift and the control.
The Evolysse™ Smooth vs Restylane-L arm also met the primary endpoint of non-inferiority and demonstrated superiority, with a mean NLF severity score difference of -0.2 (95% CI: -0.416, -0.019, non-inferiority margin 0.5) and corresponding p-value of 0.02. As a secondary endpoint, the mean grade change in the NLF severity, as assessed by the blinded, live evaluator demonstrated a statistically significant difference (p<0.05) at 6 and 9 months between Evolysse™ Smooth and the control.
The safety profiles were similar between the two Evolysse™ dermal filler products compared to their respective controls and there were no treatment-related serious adverse events.
1 Measured by comparing year-over-year revenue growth of each aesthetic neurotoxin on the market for the entirety of each comparable year.
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The forward-looking statements included herein are based on our current expectations, assumptions, estimates and projections, which we believe to be reasonable, and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements. These risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond our control, include, but are not limited to, uncertainties associated with our ability to comply with the terms and conditions in the Medytox Settlement Agreements, our ability to fund our future operations or obtain financing to fund our operations, unfavorable global economic conditions and the impact on consumer discretionary spending, uncertainties related to customer and consumer adoption of Jeuveau® and Evolysse™, the efficiency and operability of our digital platform, competition and market dynamics, our ability to successfully launch and commercialize our products in new markets, including the Evolysse™ dermal filler product line in the
Jeuveau® and Nuceiva®, are registered trademarks and Evolysse™ is a trademark of
Hi-Pure™ is a trademark of Daewoong Pharmaceutical Co, Ltd.
Estyme® is a trademark of Symatese Aesthetics S.A.S.
Restylane® is a trademark of
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