#United States #London #FDA Approval #Croma-Pharma #Obagi saypha

Croma-Pharma GmbH Celebrates FDA Approval of Obagi saypha® MagIQ™

Croma-Pharma GmbH has reached a significant milestone by announcing the FDA approval of the Obagi saypha® MagIQ™ injectable hyaluronic acid (HA) gel. This product represents the latest innovation in the Obagi saypha® collection and marks the first intradermal filler approved for commercial use in the U.S. market.

Scheduled for a commercial launch in 2026, the approval underscores Croma's strategic commitment to expanding its global footprint. With this launch, the company plans to introduce a series of products to the U.S. market, including saypha® ChIQ™ and additional innovations pending further regulatory approvals.

Andreas Prinz, the CEO of Croma-Pharma GmbH, expressed the company's pride in bringing this advanced HA technology to the U.S. through a partnership with Waldencast plc and the Obagi Medical brand. “This milestone reinforces our legacy of innovation and scientific excellence in aesthetic medicine,” Prinz stated. With over 110 million syringes produced and a presence in more than 80 markets, Croma aims to deliver high-performing products that cater to the needs of healthcare professionals and patients alike.

The Obagi saypha® MagIQ™ gel's development was supported by a pivotal U.S. study that focused on the correction of nasolabial folds (NLF). The trial involved 270 patients and confirmed the product's non-inferiority compared to FDA-approved control products, thereby meeting key performance endpoints. This comprehensive trial included participants across all Fitzpatrick skin types, assuring its effectiveness and safety on a broad demographic.

“This FDA approval validates the safety and efficacy of our saypha® filler technology and is the result of our commitment to providing scientifically-backed aesthetic solutions for medical practitioners,” Prinz added. He believes that this approval sets a solid foundation for long-term success in the competitive U.S. aesthetic market.

This launch signifies a new chapter for both Croma-Pharma and Obagi Medical, merging Croma's European HA innovations with the well-established reputation of Obagi in the U.S. skincare segment. As Croma continues its global expansion, the company is focused on innovating its portfolio, which includes HA fillers, biostimulators, PDO threads, and botulinum toxin, all aimed at equipping aesthetic physicians with comprehensive treatment tools.

About Croma-Pharma GmbH

Croma-Pharma GmbH is a family-owned company with a global presence in minimally invasive aesthetics, headquartered in Leobendorf, Austria. The company specializes in the production of hyaluronic acid injections and offers an impressive aesthetic portfolio that includes fillers, botulinum toxin, PDO threads, PRP, and skincare solutions across more than 80 countries.

About Waldencast

Waldencast is dedicated to creating a top-tier global beauty and wellness platform by developing, acquiring, and scaling purposeful and high-growth brands. The company's strategy focuses on fostering operational efficiencies whilst maintaining each brand's unique identity. The collaboration with Obagi Medical and Milk Makeup marks a significant step towards realizing Waldencast’s vision for the beauty industry.

About Obagi Medical

With over 35 years of expertise, Obagi Medical is known for its advanced skincare solutions designed to tackle a variety of skin issues, including hyperpigmentation and signs of aging. As one of the U.S.'s fastest-growing skincare brands, Obagi Medical continues to empower individuals in achieving their skincare goals through revolutionary products and clinically backed innovations.