The HA filler is designed to deliver natural-looking results with high HA content, consistent gel distribution, and a predictable injection force and swelling profile.
Waldencast plc has received approval from the US Food and Drug Administration (FDA) for Obagi saypha MagIQ, an injectable hyaluronic acid (HA) gel. The approval marks the entry of the Obagi Medical brand into the US HA dermal filler market.
The company plans to launch Obagi saypha MagIQ in the US in 2026. The launch will utilize Obagi Medical’s existing network of aesthetic professionals to create synergies between its skincare and new injectable offerings.
“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,” says Michel Brousset, co-founder and chief executive officer of Waldencast, in a release. “…The launch of this product is a catalyst for our growth as we focus on delivering synergistic skincare and injectable offerings under the trusted Obagi Medical brand.”
Developed by Croma-Pharma GmbH, Obagi saypha MagIQ uses proprietary MACRO Core Technology to create a stable 3D HA matrix. The technology is designed to provide natural-looking results with high HA content upon injection, consistent gel distribution, and a predictable injection force and swelling profile, according to the company. Additional products from the saypha line, including Obagi saypha ChIQ, are pending FDA approval.
Clinical Study and Product Profile
The FDA approval was supported by a pivotal study on the treatment of nasolabial folds. The multicenter, split-face trial included 270 patients who were followed for 48 weeks. The study met its primary and key secondary endpoints of non-inferiority to the control, with similar safety profiles reported for both treatments. The trial also included a high representation of Fitzpatrick Skin Types I, V, and VI.
“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 with precision and confidence across all skin types and tones,” says Dr Suzan Obagi, chief medical director of Obagi Medical, in a release.
Dr Jeremy Green, an investigator for the NLF pivotal study, also commented on the product’s performance. “Obagi saypha MagIQ demonstrated impressive safety, efficacy, and versatility in the trial, with smooth and consistent injection properties,” says Green, in a release. “This product allows practitioners to achieve precise, natural-looking results while delivering high patient satisfaction with its effectiveness and longevity.”
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