Revance and Teoxane Announce the FDA Approval of RHA Redensity Eye for Undereye Hollowing

Aug 26th, 2026

On August 20, Revance and Teoxane announced the FDA approval of RHA Redensity Eye from the Teoxane RHA Collection for the correction of moderate to severe tissue volume deficiencies in the undereye region, also referred to as "infraorbital hollows", in adults aged 22 years or older.¹

According to the company, the rheological profile of RHA Redensity Eye is uniquely optimized to deliver the highest dynamic strength and stretch of any hyaluronic acid (HA) filler for undereye treatment on the market.^4-5

Powered by the Teoxane RHA Collection's proprietary Preserved Network Technology (PNT), a gentle, heatless, homogenous manufacturing process that helps preserve the natural structure of HA, RHA Redensity Eye is designed to adapt to the delicate dynamics of the undereye area with results lasting up to 12 months.^1,4,6-9Additionally, the undereye region is an area of critical aesthetic consideration for patients on GLP-1 therapies as it is a common area for exhibiting fat loss.¹⁰

"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 in 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," said Nadeem Moiz, CEO of Revance. "We remain committed to delivering innovative, clinically proven solutions that give both patients and practitioners the confidence to achieve natural-looking results."

The approval is supported by positive results from the 52-week U.S. pivotal clinical study, which evaluated the safety and effectiveness of RHA Redensity Eye in a prospective, randomized, evaluator-blinded, multicenter, no-treatment-controlled study in patients with moderate to severe tissue volume deficiencies in the infraorbital region.^1,11 In that study, 93% of patients showed aesthetic improvement at 3 months.¹¹Additionally, the study achieved results lasting up to 12 months without any touch-ups.^1,12-14

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

RHA Redensity Eye is also the first hyaluronic acid gel to demonstrate effectiveness using patient-reported outcomes as a co-primary endpoint in a U.S. clinical study for the infraorbital region.¹ RHA Redensity Eye exhibited a favorable safety profile with no late-onset or serious treatment-related adverse events (TRAEs), no TRAEs deemed to be a granuloma or delayed inflammatory response, and no events of vascular occlusion.¹

"The FDA approval of RHA Redensity Eye for the infraorbital region marks a meaningful step forward for patients and practitioners alike," said board-certified dermatologist and principal investigator on the RHA Redensity Eye clinical trial, Dr. Joely Kaufman-Janette. "As a practitioner, there has long been a need for a filler that meets the unique demands of the undereye area. I'm looking forward to offering my patients a meaningful new option for one of the most requested areas of the face."

References:

RHA Redensity® Eye Instructions for Use (IFU), P170002S050D.
Bhojani-Lynch et al. Aesthet Surg J Open Forum. 2025:7:ojaf069.
Hwang CJ. J Cutan Aesthet Surg. 2016;9(2):73–79.
Faivre et al. Dermatol Surg. 2021;47(5):e159–e167.
Data on File. RDRE 2016. Geneva, Switzerland, Teoxane S.A.
Data on File. TEO-® -2004. Geneva, Switzerland, Teoxane S.A., 2025.
Monheit et al. Dermatol Surg. 2020;46(12):1521-1529.
Kaufman-Janette et al. J Cosmet Dermatol. 2019;18(5):1244-1253.
Vantou et al. Unraveling the Key Characteristics of the Preserved Network Technology (PNT): Manufacturing the Dynamic RHA® Fillers.
Jafar et al. Aesthet Surg J Open Forum. 2024; 22:6:ojae069.
Clinical Study TEO-RHA-1902.Geneva, Switzerland, Teoxane S.A., 2025.
Fabi et al. Aesthet Surg J. 2021;41(11):NP1675–NP1685.
Biesman et al. Aesthet Surg J. 2024;44(9):1001-1013.
Biesman et al. Aesthet Surg J. 2024;44(9):976–986.