FDA Approves RHA Redensity Eye for Undereye Hollowing in Adults 22 and Older
核心洞察
Revance and Teoxane (搜索) announced FDA approval of RHA Redensity Eye (搜索) for correcting moderate to severe tissue volume deficiencies in the infraorbital region in adults aged 22 or older.
The approval is supported by a 52-week pivotal study in which 93% of patients showed aesthetic improvement at 3 months, with results lasting up to 12 months without touch-ups.
RHA Redensity Eye (搜索) is the first hyaluronic acid gel to use patient-reported outcomes as a co-primary endpoint in a U.S. clinical study for the infraorbital region.
Revance and Teoxane (搜索) announced FDA approval of RHA Redensity Eye (搜索) 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 (搜索)," in adults aged 22 years or older. The infraorbital region is anatomically complex and one of the most expressive areas of the face, making proper filler selection critical to achieving natural-looking results.
The rheological profile of RHA Redensity Eye (搜索) is uniquely optimized to deliver the highest dynamic strength and stretch of any hyaluronic acid (HA) filler for undereye treatment on the market. Powered by the Teoxane (搜索) 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.
Clinical Evidence Supporting Approval
The approval is supported by positive results from a 52-week U.S. pivotal clinical study, in which the safety and effectiveness of RHA Redensity Eye (搜索) were evaluated in a prospective, randomized, evaluator-blinded, multicenter, no-treatment controlled study in patients with moderate to severe tissue volume deficiencies in the infraorbital region. In that study, 93% of patients showed aesthetic improvement at 3 months, and the study achieved results lasting up to 12 months without any touch-ups.
RHA Redensity Eye (搜索) 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. The product 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.
Expanding the Teoxane RHA Collection Portfolio
"The FDA approval of RHA Redensity Eye (搜索) for the infraorbital region is the latest advancement in what has been a defining period for the Teoxane (搜索) 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," said Nadeem Moiz, CEO of Revance.
"Treating the periorbital area is not straightforward," said Madame Valérie Taupin, CEO and Founder of Teoxane (搜索). "The properties of RHA Redensity Eye (搜索) provides 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 matters."
Clinical Significance for Patients and Practitioners
"The FDA approval of RHA Redensity Eye (搜索) 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."
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. The Teoxane (搜索) RHA Collection includes hyaluronic acid fillers with lidocaine and mepivacaine; Revance will only distribute the Teoxane RHA Collection with mepivacaine. The long-term efficacy and safety outcomes of RHA with lidocaine are applicable to RHA with mepivacaine, and mepivacaine has shown no significant impact on gel properties, including rheology and degradation profile.