08:44 AM EDT, 08/25/2025 (MT Newswires) -- Evolus ( EOLS ) said Monday that its pivotal study of Evolysse Sculpt showed statistical superiority to Restylane-Lyft in effectiveness for mid-face volume deficit.

The injectable hyaluronic acid gel product, designed to restore mid-face volume, met its primary endpoint of non-inferiority, as well as the secondary endpoint of percent of cheeks demonstrating a clinically meaningful improvement after six months, the company said.

The safety profile was similar between the two products and there were no treatment-related serious adverse events, Evolus ( EOLS ) said.

Evolus ( EOLS ) said it has submitted a premarket approval application to the US Food and Drug Administration for Evolysse Sculpt and expects approval in H2 of next year.

Shares of Evolus ( EOLS ) were up nearly 3% in recent Monday premarket activity.