US FDA approves Evolus’ two new anti-wrinkle gels

By Christy Santhosh

(Reuters) -Evolus said on Thursday the U.S. drug regulator has approved its two new anti-wrinkle gels, expanding the company’s product portfolio beyond its cosmetic injection Jeuveau.

Shares of the California-based company, which launched Botox rival Jeuveau in 2019, climbed 4.5% in afternoon trading.

It has been competing against Revance and AbbVie, among others, by targeting a younger demographic compared to other companies, which typically focus on people in their 40s.

Evolus expects the newly approved dermal fillers — Evolysse Form and Evolysse Smooth — to contribute 8%-10% to its total revenue for 2025.

The injectable gels contain hyaluronic acid and can improve the appearance of the face by restoring volume.

Evolus CEO David Moatazedi said aesthetic products form a $20 billion market globally, of which neurotoxins such as Jeuveau and Botox take the largest share, followed by hyaluronic acid fillers.

The U.S. Food and Drug Administration’s approval was based on a head-to-head study, where both the gels met the main goal of non-inferiority when compared to Switzerland-based Galderma’s Restylane-L.

Unlike Restylane-L or AbbVie’s Juvederm, Moatazedi said these gels were manufactured without multiple heating procedures so that the durability is retained.

The gels, according to Moatazedi, are approved for use in the nasolabial folds — which are creases that run from the sides of the nose to the corners of the mouth.

Evolus plans to launch the newly approved products in the U.S. in the second quarter of 2025.

The company said it also intends to launch a cheek filler called Evolysse Sculpt in 2026 and a lip filler known as Evolysse Lips in 2027.

Brokerage H.C. Wainwright expects Sculpt to become an “anchor product” for the Evolysse line, which sets it apart from Juvederm and Restylane.

(Reporting by Christy Santhosh in Bengaluru; Editing by Shilpi Majumdar)