Evolus (EOLS) announced the publication of U.S. pivotal study results for Evolysse Form and Evolysse Smooth injectable hyaluronic acid gels in the Aesthetic Surgery Journal. The study evaluated the long-term safety and effectiveness of the Cold-X crosslinked hyaluronic acid gels for correcting moderate to severe dynamic facial wrinkles and folds. Both products met the primary endpoint of non-inferiority and demonstrated statistical superiority to Restylane-L. Evolus previously received EU Medical Device Regulation approval for four hyaluronic acid gels under the brand name Estyme, with a broader European launch on track for the second half of 2025.
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