Evolus Reports Premarket Approval Application Submission to the US FDA for Evolysse Dermal Filler Products
Shots:
- Evolus has submitted a PMA application to the US FDA for Evolysse Lift and Evolysse Smooth dermal filler products addressing nasolabial fold (NLF). The decision is anticipated during H2’25
- The application was based on a US NLF pivotal trial involving 140 patients to receive Evolysse Lift or Evolysse Smooth (arm 1) and Restylane-L (arm 2) for 12mos.
- The study reached its 1EP, depicting an NLF severity score difference of -0.3 (Evolysse Lift) & -0.2 (Evolysse Smooth) with a mean grade change in NLF severity at 6wks. to 12mos. (Evolysse Lift) as well as 6mos. & 9mos. (Evolysse Smooth)
Ref: Evolus | Image: Evolus
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
