Obagi Medical Expands Into Fillers Following FDA Approval

As of this morning, the US FDA has approved Obagi saypha MagIQ, an injectable hyaluronic acid (HA) gel developed by Croma-Pharma GmbH and distributed under the Obagi Medical brand, part of Waldencast plc. This marks Waldencast’s entry into the US HA dermal filler market and the first product in the Obagi saypha collection to receive approval in the US.¹

Technology and Product Features

Obagi saypha MagIQ employs Croma-Pharma’s proprietary MACRO Core Technology. The company stated this creates a stable 3D HA matrix designed to deliver consistent gel distribution, predictable injection force, and a favorable swelling profile. The product also offers high HA content per injection, which may enhance outcomes for both patients and practitioners seeking natural-looking results.

According to a news release from the company, this approval is part of a larger rollout strategy that includes potential additional products from the saypha line, such as Obagi saypha ChIQ, which is currently under FDA review.

Clinical Evidence

The pivotal US trial for Obagi saypha MagIQ focused on the treatment of nasolabial folds (NLFs). The randomized, evaluator-blinded, active-controlled, multicenter trial enrolled 270 patients. Participants were followed for 48 weeks after treatment, with the primary endpoint assessed at 24 weeks using a validated 5-point nasolabial fold severity scale.²

The study met its primary and key secondary endpoints, demonstrating non-inferiority to the control filler, while maintaining similar safety profiles. Investigators noted that the trial included one of the highest reported representations of Fitzpatrick Skin Types I, V, and VI in HA filler studies, an important consideration for assessing outcomes across diverse skin types.

Jeremy Green, MD, investigator for the US NLF pivotal study commented in the release, “Obagi saypha MagIQ demonstrated impressive safety, efficacy, and versatility in the trial, with 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. I look forward to utilizing it in my practice in the near future.”

Perspectives from Development Partners

Croma-Pharma, the developer of the product, brings more than 4 decades of experience in HA-based technologies. The company reports having produced over 110 million syringes and conducted one of the largest clinical trial programs for injectable HA products.

“This milestone represents an exciting advancement in our long-term strategy to become the world’s leading dermatological megabrand at the crossroads of skin care and medical aesthetics with the addition of a comprehensive integrated aesthetic solution that builds upon Obagi Medical’s efficacious skin care products and strengthens our leadership in medical-grade beauty and aesthetics,” said Michel Brousset, co-founder and chief executive officer of Waldencast, in the release. “Obagi saypha MagIQ sets a new standard in HA dermal fillers in the US, offering our professionals and patients proven innovation with a well-established safety profile. 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.”

Suzan Obagi, MD, Chief Medical Director of Obagi Medical, highlighted that the FDA approval reflects the company’s focus on science-driven innovation and patient safety. She underscored that the product’s MACRO Core Technology offers a distinctive approach to addressing patient needs with precision across all skin types and tones.

Outlook

The entry of Obagi saypha MagIQ into the US filler market positions Obagi Medical to extend its reach from topical skin health solutions into injectables. If future planned products in the saypha line gain approval, Obagi Medical may further solidify its position as a comprehensive aesthetics brand.

As the aesthetics market continues to expand, the FDA approval of Obagi saypha MagIQ represents both a clinical and commercial milestone, providing dermatologists and aesthetic practitioners with another FDA-approved option for treating patients seeking dermal filler solutions.

Market Expansion and Goals

With this approval, Waldencast projects that Obagi Medical’s total addressable market will double to approximately $4.2 billion by 2029. The company plans to introduce Obagi saypha MagIQ in the US alongside other skin care innovations in 2026, leveraging its existing network of practices and aesthetic professionals. The addition of an injectable product line is intended to complement Obagi’s established portfolio of medical-grade skin care and broaden its offerings in aesthetics.

References

1. Waldencast announces FDA approval of Obagi saypha magiuq injectable hyaluronic acid gel under the Obagi medical brand. News release. Waldencast. Published September 10, 2025. Accessed September 10, 2025. https://ir.waldencast.com/news-releases/news-release-details/waldencast-announces-fda-approval-obagir-sayphar-magiqtm
2. Frank K, Downie J, Gold M, et al. Multicenter, randomized split-face trial of a crosslinked hyaluronic acid filler with lidocaine for nasolabial fold correction. Aesthet Surg J. 2025. doi:10.1093/asj/sjaf137