As of Sept. 10, the FDA has approved Obagi saypha MagIQ, a hyaluronic acid gel injectable. The injectable stands out as the first product in the Obagi Medical brand collection, and since Waldencast’s acquisition of the Obagi brand in 2022, this approval indicates the company's entry into the U.S. HA dermal filler market.
As of Sept. 10, the FDA has approved Obagi saypha MagIQ, a hyaluronic acid gel injectable. The injectable stands out as the first product in the Obagi Medical brand collection, and since Waldencast’s acquisition of the Obagi brand in 2022, this approval indicates the company's entry into the U.S. HA dermal filler market.
The global dermal filler market, reports predict, is projected to grow from 5 billion in 2025 to 8 billion by 2032 [1]. Looming in the shadow with this entry to the HA filler market, Waldencast plans to leverage Obagi Medical’s network of aesthetic professionals, who this filler pertains to, to unify the brand's medical-grade skin care products, per a Sept. 10 press release.
The commercial launch for this filler is planned for 2026, and Obagi is also seeking approval for its saypha ChIQ.
“This milestone represents an exciting advancement in our long-term strategy to become the world’s leading dermatological megabrand at the crossroads of skincare and medical aesthetics with the addition of a comprehensive integrated aesthetic solution that builds upon Obagi Medical’s efficacious skincare products,” said Michel Brousset, co-founder and CEO of Waldencast.
Obagi saypha MagIQ was developed by Croma-Pharma GmbH. Croma-Pharma, based in Austria, manufactures hyaluronic acid products and other aesthetic mechanisms. Applying Macro Core Technology, Obagi HA filler creates a 3D HA matrix, the release states, to provide natural-looking results with consistent gel distribution and a predictable injection force.
“With the introduction of its Macro Core Technology, Obagi saypha MagIQ offers a differentiated approach to the dermal filler category, providing healthcare practitioners with new options to address the unique needs of their patients,” said Suzan Obagi, MD, chief medical director of Obagi Medical.
To discover the filler's safety profile and move on to seeking FDA approval, Obagi conducted a U.S. Nasolabial Fold study. The study included 270 patients, who were followed for 48 weeks from initial treatment. The study concluded that the product met primary and secondary endpoints of non-inferiority, with representation of Fitzpatrick Skin Types I, V and VI.
Dermatologist Jeremy Green, MD was an investigator for the NLF study, who declared that the Obagi saypha MagIQ demonstrated smooth and consistent injection properties. “This product allows practitioners to achieve precise, natural-looking results while delivering high patient satisfaction with its effectiveness and longevity,” he said.
References:
1- https://www.fortunebusinessinsights.com/industry-reports/dermal-fillers-market-100939
