Waldencast Says Obagi Saypha MagIQ Injectable Hyaluronic Acid Gel Approved In U.S.

(RTTNews) - Waldencast plc (WALD) Wednesday said that the U.S. Food and Drug Administration (FDA) has approved Obagi saypha MagIQ injectable hyaluronic acid gel, the first product in the Obagi saypha collection under the Obagi Medical brand.

Waldencast plans to launch Obagi saypha MagIQ in the U.S. in 2026.

Obagi saypha MagIQ, developed by Croma-Pharma GmbH, utilizes proprietary MACRO Core Technology to provide natural-looking results.

In the U.S. Nasolabial Fold (NLF) pivotal study, patients were randomized to receive either Obagi saypha MagIQ or placebo. The study met its primary goal of non-inferiority to the control.

"This approval marks Waldencasts entry into the U.S. HA dermal filler market through Obagi Medical and reinforces the Companys ambition to become a multi-product innovator in aesthetics, doubling Obagi Medicals total addressable market to approximately $4.2 billion by 2029," the company said in a statement.