Evolus Announces Positive Data from Pivotal Trial for First Two Evolysse Dermal Filler Products at 2024 SCALE Meeting

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.