Waldencast plc announced that the U.S. Food and Drug Administration (FDA) has approved Obagi® saypha® MagIQ™ injectable hyaluronic acid (HA) gel, marking a significant milestone for the company. This approval represents Waldencast's official entry into the U.S. HA dermal filler market through its Obagi Medical brand. This strategic expansion is expected to double Obagi Medical’s total addressable market to approximately $4.2 billion by 2029.
Obagi® saypha® MagIQ™ is the first product in the Obagi® saypha® collection and utilizes proprietary MACRO Core Technology, developed by Croma-Pharma GmbH. This technology creates a stable 3D HA matrix designed to provide natural-looking results with consistent gel distribution and predictable injection force. The product's safety and efficacy were demonstrated in a 270-patient U.S. Nasolabial Fold pivotal study, which met primary and key secondary endpoints of non-inferiority to control fillers.
Waldencast plans to launch Obagi® saypha® MagIQ™ in the U.S. market in 2026, leveraging Obagi Medical’s established network of practices and aesthetic professionals. This launch is expected to create synergies with the brand’s fast-growing skincare business and drive enhanced value for both providers and patients, reinforcing Obagi Medical's leadership in medical-grade beauty and aesthetics.
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