Evolus Reports Positive Pivotal Trial Results for Evolysse™ Fillers at 2024 SCALE Meeting

Evolus, Inc., a performance beauty company, has announced promising results from its U.S. pivotal nasolabial fold (NLF) study for its dermal fillers, Evolysse™ Lift and Evolysse™ Smooth. The data were shared at the 2024 SCALE Meeting in Nashville, marking a significant milestone for the company.

David Moatazedi, President and CEO of Evolus, emphasized the importance of the study's results in the context of their forthcoming Premarket Approval (PMA) application for the U.S. market launch of these dermal fillers. According to Moatazedi, the Evolysse™ line complements their existing neurotoxin product, Jeuveau®, which has been the fastest-growing neurotoxin in the U.S. over the past three years.

Dr. Rui Avelar, Chief Medical Officer and Head of R&D at Evolus, noted that the positive results from this pivotal trial mirrored the success of an earlier European trial, reinforcing confidence in the PMA submission. Dr. Steven Dayan, who participated as an investigator in the trial, highlighted the precision and effectiveness of the Evolysse™ HA filler line, manufactured using a novel “Cold Technology” process that preserves the natural structure of the HA molecule.

The U.S. NLF pivotal study was a multicenter, blinded, split-face, controlled, non-inferiority design involving 140 patients. Participants were randomized to receive either Evolysse™ Lift or Evolysse™ Smooth in one NLF and Restylane-L in the other, allowing for direct comparison within the same patient. The primary endpoint of the study, assessed at six months, measured changes in NLF severity through a blinded independent photographic review panel using a validated 5-point nasolabial scale.

The results were compelling. The Evolysse™ Lift filler met the primary endpoint of non-inferiority and demonstrated superiority over Restylane-L, with a mean NLF severity score difference of -0.3 and a p-value of 0.03. Additionally, secondary endpoints showed statistically significant improvements in NLF severity at all timepoints from six weeks to 12 months.

Similarly, the Evolysse™ Smooth filler met its primary endpoint of non-inferiority and demonstrated superiority as well, with a mean NLF severity score difference of -0.2 and a p-value of 0.02. Secondary endpoints revealed statistically significant improvements in NLF severity at six and nine months.

The safety profiles for both Evolysse™ dermal filler products were comparable to Restylane-L, with no treatment-related serious adverse events reported. Evolus is on schedule to submit PMA applications for Evolysse™ Lift and Evolysse™ Smooth to the FDA within the next 90 days. The Evolysse™ Lift is anticipated to be the most versatile and widely used filler in the product line, while the Evolysse™ Smooth offers a softer alternative, expanding treatment options.

Evolus, Inc. continues to advance its mission of evolving the aesthetic neurotoxin market. The company's flagship product, Jeuveau®, is the first and only neurotoxin dedicated exclusively to aesthetics and is manufactured using Hi-Pure™ technology. With the planned addition of the Evolysse™ line, Evolus aims to further solidify its position in the aesthetics industry and expand its market reach.