- Evolus dermal filler, Evolysse™ Lift, 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 all measured timepoints for the entire 12-month study period
- 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
NEWPORT BEACH, Calif.--(BUSINESS WIRE)-- Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio of consumer brands, today 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.
“Achieving positive topline results in our NLF study is a pivotal step supporting the upcoming submission of our Premarket Approval application for the U.S. launch of our dermal filler lines. Complementing our flagship neurotoxin Jeuveau® – the fastest growing neurotoxin in the U.S. for the past three years1 – our Evolysse™ line of dermal fillers expands our total addressable market by 78%,” said David Moatazedi, President and Chief Executive Officer.
“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. Rui Avelar, MD, Chief Medical Officer and Head of R&D. “The R&D team remains on track to complete and submit the PMA to the FDA within the next 90 days and this data increases our confidence in the submission.”
“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. Steven Dayan, MD. “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.”
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