FDA approves RHA Redensity Eye as first hyaluronic acid filler specifically indicated for under-eye hollows
The approval provides clinicians with a dedicated injectable treatment for moderate to severe infraorbital hollowing in adults aged 22 years and older, expanding aesthetic treatment options for the under-eye region.
The US Food and Drug Administration (FDA) has approved RHA Redensity® Eye for the correction of moderate to severe tissue volume deficiencies in the infraorbital region (under-eye hollows) in adults aged 22 years and older, making it the first hyaluronic acid filler specifically approved for this indication.
The approval gives aesthetic practitioners a treatment developed specifically for the anatomically complex under-eye area, supported by clinical data demonstrating effectiveness lasting up to 12 months.
Field | Content |
Alert Type | Drug Approval |
Drug Name | RHA Redensity® Eye |
Indication | Injection into the sub-dermis and supraperiosteum for the correction of moderate to severe tissue volume deficiencies in the infraorbital region (under-eye hollows) in adults aged 22 years and older. (FDA Access Data) |
Therapy Area(s) | Aesthetic Medicine; Dermatology; Medical Devices |
Geography | United States (FDA) |
What Happened | On 20 August 2026, the FDA approved RHA Redensity® Eye, a hyaluronic acid dermal filler from Teoxane and Revance, for the correction of moderate to severe infraorbital tissue volume deficiencies in adults aged 22 years and older. The approval expands the RHA Collection with the first hyaluronic acid filler specifically indicated for under-eye hollows and was supported by a 52-week multicentre pivotal clinical study evaluating safety and effectiveness. (Revance) |
Why It Matters | The infraorbital region is one of the most technically challenging areas for injectable aesthetic treatments because of its delicate anatomy. A product specifically evaluated and authorised for this indication provides clinicians with an additional treatment option supported by clinical evidence for this patient population, although treatment outcomes remain dependent on appropriate patient selection and injection technique. (Revance) |
Supporting Context | In the pivotal study, 93% of treated patients demonstrated aesthetic improvement at three months, with results lasting up to 12 months without touch-ups. The study also reported no serious treatment-related adverse events, granulomas or vascular occlusion events related to treatment. (Revance) |
Key Takeaway | FDA approval establishes RHA Redensity® Eye as the first hyaluronic acid filler specifically indicated for correction of under-eye hollows, expanding evidence-based treatment options in facial aesthetics. (Revance) |
What to Watch | Commercial rollout in the US, adoption by aesthetic practitioners, and real-world experience following broader clinical use in the under-eye region. (Revance) |
Primary Source | |
Relevant Date | 20 August 2026 |
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