Evolus Reports Positive Data From Pivotal Study Of Evolysse Sculpt For Mid-facial Volume Restoration

rttnews
2025.08.25 13:38
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Evolus, Inc. announced positive topline results from a pivotal U.S. study of Evolysse Sculpt, an injectable hyaluronic acid gel for mid-face volume restoration. The study achieved its primary goal of non-inferiority compared to Galderma's Restylane and demonstrated statistical superiority with a mean mid-face volume deficit severity score difference of -0.26. Evolus has submitted a PMA application for Evolysse Sculpt, with approval anticipated in the second half of 2026.

Evolus, Inc. (EOLS), a performance beauty company, Monday announced positive topline results from a U.S. pivotal study of Evolysse Sculpt, an injectable hyaluronic acid (HA) gel product designed to restore mid-face volume.

The study met its primary goal of non-inferiority compared to Galderma's Restylane. The study also showed statistical superiority versus Restylane with a mean mid-face volume deficit severity score difference of -0.26.

Evolus has already submitted a PMA application for Evolysse Sculpt with approval expected in the second half of 2026.

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