08:34 AM EDT, 08/20/2025 (MT Newswires) -- Evolus ( EOLS ) said Wednesday that it has completed its premarket approval application to the US Food and Drug Administration for Evolysse Sculpt, an injectable gel designed to restore volume in the mid-face.

The company said it expects the FDA to follow its standard review process, with potential approval in the second half of 2026.

To support the application, Evolus ( EOLS ) said it conducted a US clinical trial involving 304 patients, who were monitored for 24 months to evaluate the product's safety and effectiveness.