Evolus reports positive trial results for Evolysse Sculpt dermal filler

Evolus Inc. (NASDAQ: EOLS) announced that its Evolysse Sculpt injectable hyaluronic acid gel met the primary endpoint in a pivotal U.S. trial for mid-face volume restoration. The study demonstrated the product's non-inferiority and statistical superiority compared to Restylane-Lyft.

The multicenter, double-blinded study enrolled 304 patients who were randomized to receive either Evolysse Sculpt or Restylane-Lyft. The primary endpoint measured mean grade change in mid-face volume deficit at six months using a validated 5-point scale.

Evolysse Sculpt showed a mean mid-face volume deficit severity score difference of -0.26 compared to the control, with a p-value of less than 0.001. The product achieved a 90.9% responder rate versus 83.3% for Restylane-Lyft in patients showing clinically meaningful improvement.

The safety profile was similar between both treatments, with no treatment-related serious adverse events reported during the study period. Patients were followed for 24 months from initial treatment.

The company submitted a Premarket Approval application to the U.S. Food and Drug Administration on August 20. Evolus expects FDA approval in the second half of 2026, following the standard PMA review timeline.

Evolysse Sculpt is designed using Cold-X technology intended to preserve the natural structure of the hyaluronic acid molecule. The product is manufactured by Symatese and represents Evolus's expansion beyond its Jeuveau neurotoxin product.

The information is based on a company press release statement.

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