FDA Approves RHA Dynamic Volume for Midface Contour Enhancement in Adults
核心洞察
The FDA has approved RHA Dynamic Volume (搜索), a hyaluronic acid dermal filler, for cheek augmentation and correction of age-related midface contour deficiencies (搜索) in adults 22 years and older.
A 52-week Phase III clinical trial demonstrated that RHA Dynamic Volume (搜索) showed comparable effectiveness to Juvéderm Voluma XC (搜索), with patients requiring fewer treatment sessions and touch-ups to achieve similar outcomes.
Over 94% of participants reported natural-looking and feeling results at rest and in motion up to one year post-treatment, with no perception of restricted facial movement.
Revance and Teoxane (搜索) announced the FDA approval of RHA Dynamic Volume (搜索) from the Teoxane RHA Collection for cheek augmentation and correction of age-related midface contour deficiencies (搜索) in adults aged 22 years or older. The product, formerly known as RHA 4 Mepi, will formally launch under its new name in Q1 2026.
Clinical Trial Results Support Approval
The approval is supported by positive results from a comprehensive 52-week Phase III clinical trial program. The study evaluated RHA Dynamic Volume (搜索)'s efficacy and safety in a prospective, randomized, between-subjects, double-blinded, multicenter head-to-head comparison with Juvéderm Voluma XC (搜索) in patients with moderate to severe midface volume deficiency (搜索).
Results demonstrated that RHA Dynamic Volume (搜索) showed comparable effectiveness to Voluma, with patients treated with RHA Dynamic Volume requiring fewer treatment sessions and touch-ups to achieve similar outcomes. More than 94% of participants reported natural-looking and feeling results at rest and in motion up to one year post-treatment. Patients also reported no perception of restricted facial movement, confirming the filler's adaptability to dynamic facial expressions.
Advanced Technology and Treatment Approach
RHA Dynamic Volume (搜索) is powered by Preserved Network Technology (PNT), a gentle, heatless, homogenous crosslinking process that helps preserve the natural structure of hyaluronic acid. The product is designed to provide dynamic contour enhancement and structural support, delivering lasting volume with high dynamic strength and stretch while maintaining structural integrity.
During the clinical trial program, 75% of subjects were treated in both superficial fat and deep fat to achieve balanced volume restoration, utilizing a contemporary treatment approach that aims to optimize outcomes by addressing midface volume loss comprehensively with efficient use of product.
Safety Profile and Multilayering Technique
RHA Dynamic Volume (搜索) exhibited a favorable safety profile with no late-onset or serious treatment-related adverse events, and no treatment-related adverse events deemed to be a granuloma or delayed inflammatory response.
The approval introduces the Teoxane (搜索) MLT Multilayering Technique to the U.S. market, a tailored injection approach designed for midface volume restoration using RHA Dynamic Volume (搜索) as a single, adaptable gel. This technique involves strategically placing the filler into the subcutaneous and supraperiosteal layers to restore volume, redefine contours, and harmonize facial proportions according to each patient's anatomy and aging pattern.
Industry Impact and Expert Commentary
"We are incredibly proud of the approval for midface with RHA Dynamic Volume (搜索). This news marks the second major advancement from the Teoxane (搜索) RHA Collection in the past few months, following the evolution of the Teoxane RHA Collection through the introduction of the local anesthetic Mepivacaine in late August," said Nadeem Moiz, CEO of Revance. "The new midface indication enables us to meet more patient needs than ever before."
Dr. Steven Dayan, double board-certified facial plastic surgeon and Clinical Assistant Professor at University of Illinois, commented, "The approval of RHA Dynamic Volume (搜索) for midface is an exciting advancement for the entire industry. The results we discovered during the study were incredibly profound, and I'm excited to be able to offer a tailored treatment option for my patients."
Sandra Chennoufi, Chief Scientific Officer of Teoxane (搜索), noted that "This study marks the U.S. introduction of a midface contouring approach that has been supported by more than a decade of post-marketing surveillance in Europe."
Product Specifications and Availability
RHA Dynamic Volume (搜索) provides deep structural support while allowing for natural tissue integration and facial expressiveness due to its unique rheological profile, combining high projection capacity with dynamic adaptability. The product is indicated for correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds, and for cheek augmentation and/or correction of age-related midface contour deficiencies (搜索) in adults 22 or older.
The most commonly reported side effects include injection-site redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. The product is available by prescription only and will be distributed exclusively by Revance in the United States.