September 10, 2025: Croma-Pharma GmbH, a global leader in minimally invasive aesthetic medicine, announced today that the U.S. Food and Drug Administration (FDA) has approved Obagi saypha® MagIQ™ injectable hyaluronic acid (HA) gel – the first intradermal filler product in the Obagi saypha® collection – for commercial use in the U.S. market.
Developed by Croma-Pharma and brought to the U.S. through its strategic partner Waldencast plc under the Obagi Medical brand, this FDA approval marks a significant milestone in Croma’s global expansion strategy. The commercial launch is planned for 2026 and represents the beginning of a multi-product U.S. rollout that will also include saypha® ChIQ™ and additional innovations, pending further regulatory clearance.
“We are extremely proud to bring our advanced HA technology to the United States through our collaboration with Waldencast and Obagi Medical,” said Andreas Prinz, Chief Executive Officer of Croma-Pharma GmbH. “This milestone reinforces our legacy of innovation and scientific excellence in aesthetic medicine. With more than 110 million syringes produced and a presence in over 80 markets, Croma is committed to delivering high-performing products that meet the expectations of healthcare professionals and patients worldwide.”
Obagi saypha® MagIQ™ is powered by Croma’s U.S. pivotal study for nasolabial fold (NLF) correction including 270 patients and confirming non-inferiority versus the FDA approved control product, meeting the primary performance endpoint with key secondary endpoints further reinforcing its effectiveness and safety profile. The trial included all Fitzpatrick Skin Types demonstrating the product’s effectiveness and safety across a representative population.
“This FDA approval validates the safety and performance of our saypha® filler technology and is the result of our commitment to deliver scientific data based aesthetic solutions for medical doctors” added Prinz. “We believe this will lay the foundation for long-term success in the world’s most significant aesthetic market.”,” added Prinz.
This launch marks a new chapter in the relationship between Croma-Pharma and Obagi Medical, bringing together a legacy of European HA innovation with one of the most trusted names in U.S. medical-grade skincare.
As Croma continues to expand its presence globally, the company remains focused on portfolio innovation across HA fillers, biostimulators, PDO threads, and botulinum toxin – empowering aesthetic physicians with the tools they need to deliver holistic treatment outcomes.
Leave a Reply to 2025 Medical Aesthetics Year In Review: New Indications, Approvals and Entrants into the Market – Christensen Consulting, LLCCancel reply