The FDA has approved RHA Redensity Eye, from Teoxane’s RHA Collection and marketed by Revance, for treating moderate to severe volume loss in the undereye region in adults 22 and older. The filler is built on Teoxane’s Preserved Network Technology, a heatless manufacturing process designed to preserve hyaluronic acid’s natural structure, with results intended to last up to 12 months.
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Approval rests on a 52-week US pivotal study, a randomized, evaluator-blinded, multicenter trial against no-treatment controls in patients with infraorbital volume deficiency. Ninety-three percent of patients showed aesthetic improvement at three months, and the study reported no late-onset or serious treatment-related adverse events, no granuloma or delayed inflammatory reactions, and no vascular occlusion events. It’s also the first hyaluronic acid gel to use patient-reported outcomes as a co-primary endpoint in a US infraorbital trial.
Teoxane CEO Valérie Taupin said the product’s properties are “exactly what this anatomy requires.”
The undereye area is notoriously difficult to treat well, given how thin and expressive that skin is, and this approval adds to Revance and Teoxane’s rapid buildout of the RHA Collection following last year’s mepivacaine launch and this spring’s RHA Dynamic Volume approval. The release also flags undereye hollowing as an increasingly common concern among patients on GLP-1 therapies, where rapid weight loss can affect facial fat distribution, a connection aesthetic device and filler makers have started addressing more directly in product positioning.
Revance has also strengthened its regulatory leadership, naming Melissa O’Connor as Senior Vice President, Global Regulatory. O’Connor brings more than 25 years across medical devices, combination products, biologics, and human tissue-based products, most recently as a founding member and Chief Quality and Regulatory Officer at StimLabs. Reporting to COO Nick Crowe, she’ll oversee Revance’s global regulatory strategy as the company expands its pipeline and international footprint, timing that lines up with a period of active FDA submissions like the RHA Redensity Eye approval above.
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