The FDA has approved RHA Redensity Eye for correction of moderate to severe tissue volume deficiencies in the infraorbital region in adults ages 22 and older.
Revance and Teoxane announced FDA approval of RHA Redensity Eye for correction of moderate to severe tissue volume deficiencies in the undereye region, or infraorbital hollows, in adults ages 22 and older. The hyaluronic acid filler is designed for the undereye area, with results lasting up to 12 months.
Clinical Study Results
The approval is supported by results from a 52-week U.S. pivotal clinical study evaluating the safety and effectiveness of RHA Redensity Eye. The prospective, randomized, evaluator-blinded, multicenter, no-treatment controlled study enrolled patients with moderate to severe tissue volume deficiencies in the infraorbital region.
According to the companies, 93% of patients showed aesthetic improvement at three months. Results lasted up to 12 months without touch-ups.
RHA Redensity Eye was 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, according to the announcement.
Safety Findings
The study reported no late-onset or serious treatment-related adverse events, no treatment-related adverse events considered to be granulomas or delayed inflammatory responses, and no vascular occlusion events.
The most commonly reported side effects associated with the Teoxane RHA Collection included injection-site redness, swelling, pain, tenderness, firmness, lumps or bumps, bruising, discoloration, and itching.
Unintentional injection into a blood vessel is a rare but potentially serious risk of dermal filler treatment. Reported complications of facial injections can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring.
Filler Properties and Undereye Use
RHA Redensity Eye is manufactured using Teoxane’s Preserved Network Technology, a heatless manufacturing process intended to preserve the structure of hyaluronic acid. The filler is designed to adapt to movement in the undereye area.
“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 U.S. approval is a meaningful milestone, not just commercially, but as a confirmation that our technology and precision formulation matters.”
The companies also noted that the undereye region can exhibit fat loss in patients receiving GLP-1 therapies.
New Option for the Infraorbital Region
“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.”
RHA Redensity Eye joins the Teoxane RHA Collection of hyaluronic acid fillers. The product is indicated specifically for correction of moderate to severe tissue volume deficiencies in the infraorbital region in adults ages 22 and older.
Photo: ID 182830140 © Viacheslav Iacobchuk | Dreamstime.com
