Evolus receives nod from EU for hyaluronic acid injectables, anticipates US approval

Key takeaways:

• Branded as Estyme in the EU and Evolysse in the U.S., the hyaluronic acid injectables have received the EU’s Medical Device Regulation certification.
• The product will now be on the market for select physicians.

Four injectable hyaluronic acid gels used as dermal filler have received the EU Medical Device Regulation certification, making the products commercially available in the European Union, Evolus Inc. announced in a press release.

The EU’s Medical Device Regulation (MDR) process ensures that products adhere to strict safety, efficacy and quality standards before hitting the market.

Branded as Estyme in the EU and Evolysse in the U.S., the company will introduce Estyme to select physician partners across Europe through a limited experience program. A larger European launch is expected in the second half of 2025, according to the release.

“The MDR CE mark certification for Estyme is a critical milestone in our strategic path to expand our product portfolio and reflects our commitment to delivering high-quality gels that adhere to the most rigorous regulatory standards,” David Moatazedi, MBA, president and CEO of Evolus, said in the press release. “With Estyme, we are bringing a new level of excellence to the dermal filler category, as we grow our product portfolio to meet growing consumer demand for premium, cash-pay aesthetic treatments.”

According to the release, the company anticipates U.S. approval and launch in the beginning of 2025.