FDA Accepts Review of SKINVIVE by Juvéderm for Neck Line Treatment Expansion
Key Insights
Allergan Aesthetics (search) has received FDA acceptance for review of its supplemental premarket approval application to expand SKINVIVE by Juvéderm (search)'s indication from cheek smoothness to include neck line treatment.
A multicenter randomized controlled trial demonstrated that 80% of patients achieved at least a 1-grade improvement in horizontal neck lines (search) at one month, with nearly 90% reporting visible neck appearance improvement.
If approved, SKINVIVE would become the first FDA-approved hyaluronic acid-based injectable specifically targeting horizontal neck lines (search), addressing a top aesthetic concern among millions of patients.
Allergan Aesthetics (search), an AbbVie (search) company, announced that the U.S. Food and Drug Administration has accepted for review its supplemental premarket approval (sPMA) application for SKINVIVE by Juvéderm (search) to expand its indication to include neck line treatment. Currently approved for enhancing cheek smoothness in adults aged 21 and older, the potential expansion would make SKINVIVE the first hyaluronic acid injectable specifically targeting horizontal neck lines (search).
The FDA's acceptance follows growing demand for comprehensive lower face and neck solutions that avoid surgical intervention. According to Allergan Aesthetics (search), millions of individuals actively seek professional treatments to improve their neck appearance, with neck lines (search) consistently ranking among the top aesthetic concerns.
Clinical Trial Results Support Expansion
The sPMA application is backed by data from a multicenter, evaluator-blinded, randomized controlled trial evaluating SKINVIVE's efficacy and safety in adults with moderate to severe horizontal neck lines (search). The study met all primary and secondary endpoints.
Based on investigator ratings, 80% of patients treated with SKINVIVE demonstrated at least a 1-grade improvement in horizontal neck lines (search) after one month of treatment. Nearly 90% of participants reported visible improvement in their neck's appearance, as measured by the Global Aesthetic Improvement Scale.
Patient-reported outcomes showed significant improvements in satisfaction. Patients receiving SKINVIVE treatment reported being significantly less bothered by their neck's appearance post-treatment, as captured using the FACE-Q questionnaire, a validated tool measuring patient satisfaction with aesthetic outcomes. In contrast, patients in the control group did not report significant changes.
Safety Profile Remains Consistent
The clinical trial reported no serious adverse events. Treatment-emergent side effects were generally mild in nature and consistent with the known safety profile of hyaluronic acid-based injectables. The findings will be submitted for peer-reviewed publication and presentation at an upcoming medical conference.
"SKINVIVE by Juvéderm (search) is an injectable version of hyaluronic acid, a naturally occurring molecule found in the skin and important for skin hydration," said Darin Messina, PhD, senior vice president, aesthetics R&D, AbbVie (search). "The submission of SKINVIVE by Juvéderm to treat neck lines (search) demonstrates our continued focus on developing new indications for comprehensive lower face and neck treatment as part of our market-leading portfolio of products, including BOTOX Cosmetic and SkinMedica (search)."
Addressing Unmet Clinical Need
Jeanine Downie, MD, FAAD, a board-certified dermatologist and clinical investigator involved in the trial, emphasized the real-world relevance of the treatment. "Patients express frustration about the visible changes in their neck due to aging (search) and sun exposure and seek non-surgical treatment options to address them," Downie said. "SKINVIVE by Juvéderm (search) may offer another tool for patients exploring their aesthetics treatment journey beyond the face."
The potential approval would address a significant gap in aesthetic treatment options. Currently, SKINVIVE by Juvéderm (search) is approved as the first and only hyaluronic acid microdroplet injectable indicated to improve cheek skin smoothness. The neck indication expansion would provide practitioners with a new tool for comprehensive facial and neck rejuvenation approaches.
Market Impact and Future Implications
If approved, this expansion would mark a significant milestone in aesthetic medicine, providing the first FDA-approved hyaluronic acid-based injectable aimed specifically at improving the appearance of horizontal neck lines (search). The development reflects the broader trend toward non-surgical aesthetic treatments that address multiple areas of concern in a single treatment paradigm.
The move aligns with Allergan Aesthetics (search)' strategy to develop comprehensive treatment solutions within its aesthetics portfolio, which includes established products like BOTOX Cosmetic and SkinMedica (search) skincare products. The company continues to focus on expanding indications for existing products while maintaining safety and efficacy standards.