Evolus’ Evolysse Lift and Smooth fillers met the primary endpoint of non-inferiority and demonstrated superiority to Restylane-L at six months for the treatment of nasolabial folds, according to topline results from a U.S. pivotal nasolabial fold (NLF) study of dermal filler products.
Data were presented at the 2024 SCALE Meeting in Nashville.
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 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.
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 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 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 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 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.
“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,” says Steven Dayan, MD, a Chicago facial plastic surgeon, in a news release. “Clinically, I found the product to be precise and I could treat patients to optimal correction. I was also struck by the fact that despite using the same amount of product between the treatment and control, there seems to be more of a difference in the correction when looking at the Evolysse treatment arm.”
