Evolus, a performance beauty company specializing in developing a diverse portfolio of consumer brands, has announced the submission of the final module of its premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its Evolysse™ Lift and Evolysse™ Smooth dermal filler products intended for nasolabial folds (NLF).
Dr. Rui Avelar, MD, Chief Medical Officer and Head of R&D, expressed satisfaction with reaching this milestone: “We are pleased to have submitted the final module of the PMA application. This submission marks a significant milestone for Evolus, and we look forward to collaborating closely with the FDA during the thorough review process.”
Evolus anticipates that the FDA’s review process will follow the standard timeline, with potential approval expected in the latter half of 2025. The submission underscores Evolus’ commitment to launching these dermal filler products and its preparedness to meet rigorous regulatory standards.
The PMA application includes findings from a pivotal U.S. study evaluating the safety and efficacy of both products in a multicenter, blinded, split-face, controlled trial over a 12-month follow-up period. The study enrolled 140 patients, evenly split across two investigational groups. Patients were randomly assigned to receive either Evolysse™ Lift or Evolysse™ Smooth in one NLF, with Restylane-L used as a control in the opposite NLF. This design allowed each patient to experience one of the Evolysse™ fillers and the control simultaneously.
Both Evolysse™ Lift and Evolysse™ Smooth met their primary endpoint of non-inferiority and demonstrated superiority over Restylane-L at the 6-month mark. Further details on the study are available [here](link to study if provided).
Evolysse™ Lift is positioned as the most versatile option for treating facial wrinkles and folds, particularly NLFs, expected to be the flagship product in the line. Evolysse™ Smooth, offering a softer formulation alternative to Evolysse™ Lift, will cater to specific patient preferences in aesthetic treatments.
