RHA Redensity Eye Receives FDA Approval for Undereye Hollowing
The U.S. Food and Drug Administration (FDA) has approved 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.
The Teoxane RHA Collection’s proprietary Preserved Network Technology (PNT) helps preserve the natural structure of hyaluronic acid (HA), with RHA Redensity Eye results lasting up to 12 months.
Approval is supported by positive results from a 52-week U.S. pivotal clinical study, where the safety and effectiveness of RHA Redensity Eye 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. Additionally, the study achieved results lasting up to 12 months without any touch-ups.
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. 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.
