Evolus has submitted the final module of its PMA application to the FDA for Evolysse Sculpt, an injectable HA gel for mid-face volume restoration.
Evolus Inc has submitted the final module of its Premarket Approval application to the U.S. Food and Drug Administration for Evolysse Sculpt, an injectable hyaluronic acid gel designed for mid-face volume restoration.
Product Designed for Mid-Face Volume
According to the company, Evolysse Sculpt is its most structured injectable gel product. “This submission represents an important milestone in expanding our Evolysse collection of injectable HA gels,” said Dr Rui Avelar, chief medical officer and Head of R&D. “Sculpt is our most structured product, manufactured using a novel technology and designed to address mid-face volume loss, a high-value segment in facial aesthetics.”
FDA Approval Anticipated in 2026
Evolus expects the FDA will follow its standard PMA process, with approval anticipated in the second half of 2026. The company states that the submission reflects its preparedness to meet regulatory standards and its goal to expand its aesthetic injectable portfolio.
U.S. Pivotal Study Data Supports Submission
The PMA application is backed by data from a U.S. study evaluating safety and effectiveness in a multi-center, double-blinded, controlled, non-inferiority trial. The study followed 304 patients for 24 months after initial treatment, comparing Evolysse Sculpt with Restylane-Lyft.
Evolysse Sculpt Positioned as Flagship Product
Evolysse Sculpt is expected to serve as the lead product in the Evolysse collection. Developed by Symatese using Cold-X technology, it is designed to preserve the HA molecule’s natural structure, aiming for long-lasting, natural-looking results. The product targets the high-value mid-face filler market and will be among the limited number of fillers with an indication for that area.
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