Merz Aesthetics, the world’s largest dedicated medical aesthetics business, announced that it has submitted Premarket Approval (PMA) applications to the U.S. Food and Drug Administration (FDA) for Belotero® Volume Lidocaine and Belotero® Intense Lidocaine. The milestone is an important step toward expanding access to advanced hyaluronic acid (HA) options for patients and health care professionals in the U.S.
The Belotero portfolio of HA treatments is manufactured using a highly innovative patented Dual Cross-Linking Technology that leads to a Cohesive Polydensified Matrix (CPM)® gel. Belotero Volume Lidocaine is designed to restore facial volume, and Belotero Intense Lidocaine is designed for lip enhancement.
“We are advancing solutions to help patients achieve safe, natural-looking outcomes that work with the body by combining rigorous clinical evidence with cutting-edge technology,” said Dr. Samantha Kerr, Chief Scientific Officer, Merz Aesthetics. “These submissions are a key milestone as we continue to support our customers and innovate in the HA filler space.”
The PMA applications are supported by two pivotal multicenter, randomized, comparator-controlled, evaluator-blinded clinical studies that evaluated the safety and effectiveness of Belotero Volume Lidocaine and Belotero Intense Lidocaine. Merz Aesthetics anticipates that the FDA’s review will follow the standard PMA review process, with approval anticipated in 2026.
“These submissions will expand our U.S. product range with an all-important broad hyaluronic acid treatment portfolio that today’s patients are requesting,” said Patrick Urban, President, North America, Merz Aesthetics. “They dovetail well with our focus on expanding access to innovative aesthetic solutions that meet the evolving needs of providers and patients alike.”
About Merz Aesthetics
Merz Aesthetics is a medical aesthetics business with a long history of empowering health care professionals, patients and employees to live every day with confidence. We aim to help people around the world look, feel and live like the best versions of themselves — however they define it. Clinically proven, its product portfolio includes injectables, devices and skin care treatments designed to meet each patient’s needs with high standards of safety and efficacy. Being family owned for more than 115 years, Merz Aesthetics is known for building unique connections with customers who feel like family. Merz Aesthetics’ global headquarters is in Raleigh, N.C., USA, with a commercial presence in 90 countries worldwide. It is also a part of Merz Group, which was founded in 1908 and is based in Frankfurt, Germany. Learn more at merzaesthetics.com.
About Belotero
Belotero Intense Lidocaine and Belotero Volume Lidocaine are not yet approved by the U.S. Food and Drug Administration.
© 2025 Merz North America, Inc. All rights reserved. BELOTERO, MERZ and MERZ AESTHETICS are trademarks and/or registered trademarks of Merz Pharma GmbH & Co. KGaA in the U.S. and/or certain other countries. Cohesive Polydensified Matrix CPM is a trademark and/or registered trademark of Merz Pharma GmbH & Co. KGaA in the European Union and/or certain countries.
Media Contact:
Merz Aesthetics
6501 Six Forks Road
Raleigh, NC 27615
919-302-3296
Media@merz.com