FDA Clears New RHA Filler for Undereye Volume Deficiency

The FDA has approved RHA Redensity Eye, part of the Teoxane RHA Collection, for correction of moderate to severe tissue volume deficiencies in the undereye region, or infraorbital hollows, in adults aged 22 years or older, according to an announcement from Revance and Teoxane.

The hyaluronic acid (HA) filler is manufactured using Teoxane’s proprietary Preserved Network Technology, a heatless manufacturing process designed to preserve the structure of HA. According to the companies, RHA Redensity Eye is formulated with rheological properties intended for the dynamic anatomy of the infraorbital region.

Pivotal Study Supports RHA Redensity Eye Approval

The approval was supported by a 52-week, prospective, randomized, evaluator-blinded, multicenter, no-treatment controlled US pivotal study evaluating safety and effectiveness in patients with moderate to severe infraorbital tissue volume deficiencies. The companies reported that 93% of patients demonstrated aesthetic improvement at 3 months. Results were reported to last up to 12 months without touch-ups.

The companies also reported that RHA Redensity Eye showed effectiveness using patient-reported outcomes as a co-primary endpoint. There were no late-onset or serious treatment-related adverse events, and no treatment-related events were considered granulomas or delayed inflammatory responses. No vascular occlusions were observed. 

“The FDA approval of RHA Redensity Eye for the infraorbital region marks a meaningful step forward for patients and practitioners alike,” said Joely Kaufman-Janette, MD, a board-certified dermatologist and principal investigator in the clinical trial, said in the press release. “As a practitioner, there has long been a need for a filler that meets the unique demands of the undereye area.”

Source

Revance press release. August 20, 2026.