Evolus, Inc. announced positive topline results from a U.S. pivotal nasolabial fold (NLF) study of dermal filler products Evolysse? Lift and Smooth. Data were presented at the 2024 SCALE Meeting on May 17, 2024, in Nashville.

Study Design: The U.S. NLF pivotal study was a multicenter, blinded, split face, controlled, non-inferiority design. Patients were followed for 12 months from initial treatment. A total of 140 patients were enrolled and divided evenly across two investigational arms. Patients were randomized to receive Evolysse?

Lift or Evolysse? Smooth in one NLF and Restylane-L in the contralateral NLF. This split face design allowed each individual patient to experience one of the Evolysse?

fillers and the control at the same time. 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.

Evolus remains on track to submit Premarket Approval (PMA) applications for the first two Evolysse? dermal filler products with the FDA within the next 90 days. The Evolysse?

Lift filler will be positioned as the most versatile and highest use filler in the product line. The Evolysse? Smooth filler is a softer product than Lift, providing additional versatility.