Nashville, Tennessee, August 20, 2026
Revance and Teoxane have announced FDA approval for RHA Redensity® Eye, a hyaluronic acid (HA) dermal filler designed for the correction of moderate to severe tissue volume deficiencies in the infraorbital region, commonly known as undereye hollows, in adults aged 22 years and older. The approval expands the Teoxane RHA® Collection into one of the most delicate and clinically challenging areas of facial aesthetics. The product is designed to provide natural-looking results lasting up to 12 months, according to the companies.
FDA Approval Expands Undereye Treatment Options
The RHA Redensity Eye FDA approval is supported by data from a 52-week U.S. pivotal clinical study evaluating patients with moderate to severe infraorbital tissue volume deficiencies. The prospective, randomized, evaluator-blinded, multicenter study compared treatment with a no-treatment control. According to the reported results, 93% of patients demonstrated aesthetic improvement at three months, while treatment effects were reported to last for up to 12 months without touch-ups. The companies said the product also represents the first hyaluronic acid gel to demonstrate effectiveness using patient-reported outcomes as a co-primary endpoint in a U.S. clinical study focused on the infraorbital region. The clinical evaluation reported a favorable safety profile, with no late-onset or serious treatment-related adverse events, granuloma or delayed inflammatory response, or vascular occlusion events observed in the study.
Hyaluronic Acid Technology Targets Delicate Anatomy
RHA Redensity Eye is based on the Teoxane RHA Collection’s Preserved Network Technology (PNT), described as a gentle, heatless and homogeneous manufacturing process intended to preserve the natural structure of hyaluronic acid. The formulation is designed around the dynamic characteristics of the undereye area, with properties intended to support flexibility and tissue adaptation. The companies highlighted the product’s rheological profile, including its dynamic strength and stretch, as key characteristics for treatment of the anatomically complex infraorbital region. The approval also arrives as demand for facial rejuvenation continues to expand across different patient populations. Revance noted that the undereye area can be particularly relevant for patients receiving GLP-1 therapies, where facial fat loss may contribute to changes in the appearance of the region. RHA Redensity Eye adds another targeted option to the company’s growing aesthetics portfolio, alongside other products in the RHA Collection used for facial wrinkles, folds and volume deficiencies.
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Safety Profile and Broader Aesthetic Portfolio
As with other dermal fillers, patient safety and appropriate administration remain important considerations. The product information states that RHA injectable gels should not be used in patients with certain severe allergies or bleeding disorders, and the products are intended for administration by appropriately trained healthcare professionals. Reported side effects associated with RHA fillers include injection-site redness, swelling, tenderness, firmness, lumps or bumps, bruising, discoloration, pain and itching. Rare but serious complications can occur if filler is unintentionally injected into a blood vessel, including vision abnormalities, blindness, stroke, skin necrosis and other tissue damage. The FDA approval strengthens Revance’s aesthetics and skincare portfolio while supporting Teoxane’s strategy of advancing hyaluronic acid-based technologies for facial aesthetic applications. Revance develops and distributes products spanning aesthetics, skincare and therapeutics, while Teoxane specializes in hyaluronic acid solutions and aesthetic treatments. The companies said the new approval represents an important milestone for expanding treatment options for the highly sought-after undereye region.
Source: Revance press relese
