New HA Filler Obagi® saypha® MagIQ™ Approved by FDA
The US Food and Drug Administration (FDA) has approved Obagi® saypha® MagIQ™, an injectable hyaluronic acid (HA) gel, marking the first product in the Obagi® saypha® collection under the Obagi Medical brand, Waldencast plc announced.
The approval introduces Waldencast plc into the US HA dermal filler market and is expected to significantly expand Obagi Medical’s aesthetics portfolio.
Developed by Croma-Pharma GmbH, Obagi® saypha® MagIQ™ incorporates proprietary MACRO Core Technology, which creates a stable 3D HA matrix, the company says. The technology is designed to provide natural-looking outcomes, consistent gel distribution, and a predictable injection force and swelling profile. Waldencast said it plans to commercially launch the product in 2026, leveraging Obagi Medical’s established practice network. Additional products in the saypha® line, including Obagi® saypha® ChIQ™, are pending FDA review.
The U.S. Nasolabial Fold (NLF) study enrolled 270 patients in a randomized, evaluator-blinded, split-face, active-controlled, multicenter noninferiority trial. Patients were followed for 48 weeks, with the 24-week primary endpoint measuring changes in NLF severity using a validated 5-point scale. Obagi® saypha® MagIQ™ met both primary and key secondary endpoints, demonstrating noninferiority to the control with comparable safety outcomes. The study included a broad representation of Fitzpatrick skin types I, V, and VI.
“Obagi® saypha® MagIQ™ demonstrated impressive safety, efficacy, and versatility in the trial, with smooth and consistent injection properties," investigator Jeremy Green, MD, said in a press release. "This product allows practitioners to achieve precise, natural-looking results while delivering high patient satisfaction with its effectiveness and longevity.”
Michel Brousset, co-founder and CEO of Waldencast, said the apprvoal 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."
Suzan Obagi, MD, chief medical director of Obagi Medical, said it reflects a commitment to bringing high-quality, science-backed aesthetic products to market,.
“With the introduction of its MACRO Core Technology, Obagi® saypha® MagIQ™ offers a differentiated approach to the dermal filler category," Dr. Obagi said, "providing healthcare practitioners with new options to address the unique needs of their patients across all skin types and tones.”