Evolus Submits Premarket Approval Application to FDA for two Evolysse Dermal Filler Products

Evolus Submits Premarket Approval Application to FDA for two Evolysse Dermal Filler Products

By, Admin 27 June 2024

Overview

Evolus, Inc, a performance beauty company with a focus on building an aesthetic portfolio of consumer brands, announced that it has submitted the final module of its premarket approval (PMA) application to the US Food and Drug Administration (FDA) for the Evolysse Lift and Evolysse smooth dermal filler products for the nasolabial fold (NLF).

Statement from R&D Expert

  • “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.”

Anticipated Approval: 2025

  • 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.

Contents pf PMA Application

  • The PMA application includes results from the US 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.

Primary Endpoint

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.

Evolysse Lift Filler

  • 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.

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