Evolus has reported that its mid-face filler Evolysse Sculpt outperformed Restylane-Lyft in a pivotal U.S. trial.
Evolus Inc has reported positive topline results from a pivotal U.S. clinical trial evaluating Evolysse Sculpt, an injectable hyaluronic acid gel intended for mid-face volume restoration. The company said the product met its primary and secondary endpoints and showed statistical superiority to Restylane-Lyft.
Study Design
The randomized, double-blinded study enrolled 304 patients across multiple centers. Subjects received either Evolysse Sculpt or Restylane-Lyft and were monitored for 24 months. The primary endpoint, assessed at 6 months, measured the change in mid-face volume using a validated five-point photo-numeric scale evaluated by a blinded live assessor.
Results
Evolysse Sculpt demonstrated a statistically significant improvement in mid-face volume over Restylane-Lyft, with a mean score difference of -0.26 (95% CI [ -0.45, -0.07]; p < 0.001), meeting the study’s criteria for non-inferiority and achieving statistical superiority.
The secondary endpoint, which measured the percentage of cheeks with at least a one-point improvement, also favored Evolysse Sculpt. The product showed a 90.9% responder rate compared to 83.3% for Restylane-Lyft (p = 0.015). The safety profile was comparable between the two groups, and no treatment-related serious adverse events were reported.
FDA Submission and Timeline
Evolus has submitted a Premarket Approval application to the U.S. Food and Drug Administration. The company expects a standard review process, with potential approval in the second half of 2026.
“Achieving positive topline results in our mid-face study is an important milestone for Evolus as we expand beyond Jeuveau with the Evolysse line,” said David Moatazedi, president and chief executive officer.
Physician and R&D Commentary
“The Evolysse Sculpt study in patients seeking cheek augmentation demonstrated high patient satisfaction and a similar safety profile to the control,” said Rui Avelar, MD, chief medical officer and head of R&D. “We are pleased to have recently submitted our Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) and look forward to the next phase of bringing this innovative product to patients and practitioners in the U.S.”
“As an investigator in this pivotal study, I was impressed by the durability of results and high levels of patient satisfaction achieved with Evolysse Sculpt,” said Gilly Munavalli, MD, MHS. “The product handled exceptionally well during injection, delivering the lift and contouring in the mid-face we seek in daily practice.”
Product Details
Evolysse Sculpt is manufactured by Symatese using Cold-X technology, which is designed to preserve the natural structure of the hyaluronic acid molecule. Evolus plans to position it as the lead product in its Evolysse collection.
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