ICYMI: FDA Clears RHA Redensity Eye for Infraorbital Hollowing

The US Food and Drug Administration (FDA) has approved RHA Redensity Eye, part of the Teoxane RHA Collection, for the correction of moderate to severe tissue volume deficiencies in the infraorbital region, or undereye hollows, in adults aged 22 years and older, according to Revance and Teoxane’s announcement yesterday.¹

HA Formulation for the Periorbital Region

The hyaluronic acid (HA) filler is designed for use in the anatomically complex and highly expressive periorbital region. According to the companies, its rheological profile is optimized for the dynamics of the undereye area, with characteristics including spreadability, stretch, and a soft profile. The product uses the Teoxane RHA Collection’s proprietary Preserved Network Technology (PNT), a heatless manufacturing process intended to preserve the natural structure of HA.

"The FDA approval of RHA Redensity Eye for the infraorbital region is the latest advancement in what has been a defining period for the Teoxane RHA Collection. Following the launch of the Teoxane RHA Collection with mepivacaine in August 2025 and RHA Dynamic Volume March 2026, we are continuing to expand our portfolio into the areas patients care about most, and the infraorbital region is one of the most delicate and sought-after in facial rejuvenation," Nadeem Moiz, CEO of Revance, said in the press release. "We remain committed to delivering innovative, clinically proven solutions that give both patients and practitioners the confidence to achieve natural-looking results."¹

Efficacy and Safety Profile

The approval was supported by a 52-week US pivotal clinical study evaluating the safety and effectiveness of RHA Redensity Eye in patients with moderate to severe infraorbital tissue volume deficiencies.² The prospective, randomized, evaluator-blinded, multicenter study included a no-treatment control group. At 3 months, 93% of patients demonstrated aesthetic improvement. The data also showed that treatment results lasted for up to 12 months without touch-ups.

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RHA Redensity Eye was also the first HA gel to demonstrate effectiveness using patient-reported outcomes as a co-primary endpoint in a US clinical study for the infraorbital region, according to the press release. The product demonstrated a favorable safety profile in the pivotal study. No late-onset or serious treatment-related adverse events were reported, and no treatment-related events were considered granulomas or delayed inflammatory responses. There were also no reported cases of vascular occlusion.

"Treating the periorbital area is not straightforward," said Valérie Taupin, CEO and founder of Teoxane. "The properties of RHA Redensity Eye provides an answer for it. Its spreadability, stretch, and soft profile are exactly what this anatomy requires. This US approval is a meaningful milestone, not just commercially, but as a confirmation that our technology and precision formulation matters."¹

Addressing Unique Anatomical Challenges and Trends

The companies noted that the infraorbital region can present particular challenges for aesthetic treatment because of its anatomy and movement. The filler was developed to adapt to these characteristics while addressing volume deficiencies in the area. The approval also comes as clinicians increasingly encounter patients receiving glucagon-like peptide-1 (GLP-1) therapies. As the companies noted, the undereye region is one area where fat loss may be apparent in patients receiving these therapies.

RHA Redensity Eye is part of the broader Teoxane RHA Collection of resilient HA fillers. Revance distributes the collection with mepivacaine in the US. Other approved products in the collection have indications addressing dynamic facial wrinkles and folds, lip fullness, cheek augmentation, and age-related midface contour deficiencies.

“Hollowing under the eyes is one of the most common concerns that brings patients to my office. This has been a tricky area to treat properly, as for a long time, we have had limited options that were specifically designed to address this unique area. RHA Redensity Eye fills a genuine gap in how we treat this area, and the strength of the clinical data behind it gives me confidence that this new indication will be well-received by my patients,” board-certified dermatologist, director of Skin Associates of South Florida and the Skin Research Institute in Miami, Florida, and principal investigator of the RHA Redensity Eye clinical trial, Joely Kaufman-Janette, MD, said in an exclusive statement to Dermatology Times.

References

1. Revance and Teoxane Announce the FDA Approval of RHA Redensity® Eye for Undereye Hollowing. News release. PR Newswire. Published August 20, 2026. Accessed August 21, 2026. https://www.prnewswire.com/news-releases/revance-and-teoxane-announce-the-fda-approval-of-rha-redensity-eye-for-undereye-hollowing-302855805.html

2. Clinical Study TEO-RHA-1902. Geneva, Switzerland, Teoxane S.A., 2025.