Evolus, Inc. announced that it has submitted the final module of its premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the Evolysse? Lift and Evolysse? Smooth dermal filler products for the nasolabial fold.

Evolus anticipates that the FDA?s review process will adhere to the standard timeline, with approval expected in the second half of 2025. The submission underscores Evolus? commitment to bringing the dermal filler products to market and its readiness to meet regulatory requirements.

The PMA application includes results from the U.S. pivotal study, which evaluated 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. 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. Both the Evolysse? Lift and Evolysse?

Smooth dermal filler products met their primary endpoint of non-inferiority and demonstrated superiority to Restylane-L at 6 months. The Evolysse? Lift filler will be positioned as the most versatile for treating facial wrinkles and folds (such as NLFs) and is expected to be the highest use filler in the product line.

The Evolysse? Smooth filler will be positioned as an alternative softer formulation option to Evolysse? Lift.