Performance Beauty Company Submits Premarket Approval Application for Dermal Filler Products

Evolus, Inc. submitted the final module of its permarket approval (PMA) application to the US Food and Drug Administration for dermal filler products.

Evolysse Lift and Evolysse Smooth dermal fillers are for the nasolabial fold (NLF). 

Evolus expects the FDA’s review process to adhere to the standard timeline and approval is anticipated in the second half of 2025. The company says they are committed to bringing their dermal filler products to the market. 

“We are pleased to have submitted the final module of the PMA application,” said Dr. Rui Avelar, MD, Chief Medical Officer and Head of R&D. “This submission is a key fundamental milestone for Evolus and we look forward to our continued collaboration with the Agency in the upcoming thorough review process.” 

The application process includes from the US pivotal study, which evaluates the safety and effectiveness of the products in a multicenter, blinded, split face, controlled, non-inferiority designed trial. 

Patients were followed for 12 months from initial treatment, with a total of 140 patients enrolled and divided evenly across two investigational arms. There was a randomization of patients receiving Evolysse Lift or Evolysse Smooth in one NLF and Restylane-L in the contralateral NLF. The spilt face design allows each patient to experience one of the Evolysse fillers and the control at the same time. 

Both products met their primary endpoint at 6 months. 

The Evolysse Lift filler is anticipated to be positioned as the most versatile for treating facial wrinkles and folds and be the highest use filler in the product line, the company said in a press release. The Evolysse Smooth filler is an alternative softer formulation option.