Evolus announces submission of PMA to U.S. FDA for two Evolysse products

Evolus 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, NLF. 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.