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Evolus Announces Submission of Premarket Approval Application to the U.S. Food and Drug Administration for First Two Evolysse™ Dermal Filler Products
NEWPORT BEACH, Calif.--(BUSINESS WIRE)-- Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio of
About this update from Evolus, Inc. Common Stock
[{"type":"text","content":" NEWPORT BEACH, Calif.--(BUSINESS WIRE)--\nEvolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio of consumer brands, today 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).\n\n\n“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.”\n\n\nEvolus 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.\n\n\nThe 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.\n\n\nBoth 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. More information on the study is available here.\n\n\nThe 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.\n\n\nAbout Evolus, Inc.\n\n\nEvolus (NASDAQ: EOLS) is a global performance beauty company evolving the aesthetic neurotoxin market for the next generation of beauty consumers through its unique, customer-ce...