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SKINVIVE by JUVÉDERM® is currently approved in the U.S. as the first and only hyaluronic acid microdroplet injectable indicated to improve cheek skin smoothness.
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If approved, SKINVIVE by JUVÉDERM® will be the first hyaluronic acid injectable treatment option aiming to reduce neck lines.
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The application for indication expansion is supported by a clinical study that met all primary and secondary endpoints assessing SKINVIVE by JUVÉDERM® in adults with neck lines seeking improvement in neck appearance.1
IRVINE, Calif., June 30, 2025 /PRNewswire/ -- Allergan Aesthetics, an AbbVie company (NYSE: ABBV), today announced that the U.S. Food and Drug Administration (FDA) accepted for review the supplemental premarket approval (sPMA) application for SKINVIVE by JUVÉDERM® to reduce neck lines for the improvement of neck appearance. SKINVIVE by JUVÉDERM® is currently approved in the U.S. to improve skin smoothness of the cheeks in adults over the age of 21.
"SKINVIVE by JUVÉDERM® is an injectable version of hyaluronic acid, a naturally occurring molecule found in the skin and important for skin hydration," said Darin Messina, Ph.D., senior vice president, aesthetics R&D, AbbVie. "The submission of SKINVIVE by JUVÉDERM® to treat neck lines 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®."
Neck appearance is a top concern among people seeking aesthetic treatment, with millions of consumers considering professionally administered treatments to address their neck concerns.2 SKINVIVE by JUVÉDERM® could offer the first hyaluronic acid injectable that aims to reduce neck lines to improve neck appearance.
The sPMA submission is supported by data from a multicenter, evaluator-blinded, randomized controlled study evaluating the safety and effectiveness of SKINVIVE by JUVÉDERM® in adults with moderate to severe horizontal neck lines seeking improvement in neck appearance.1 All primary and secondary endpoints were met.1 Based on investigator assessment of horizontal neck lines, 80% of patients treated with SKINVIVE by JUVÉDERM® achieved at least a 1-grade improvement at month 1.1,3 Nearly 90% of patients treated with SKINVIVE by JUVÉDERM® reported improvement in neck appearance at month 1 as assessed by the Global Aesthetic Improvement Scale.1 Patients treated with SKINVIVE by JUVÉDERM® reported being significantly less bothered with the overall appearance of their neck following treatment as measured by the FACE-Q questionnaire, while patients in the control group demonstrated no significant change.1 Treatment-emergent adverse events for SKINVIVE by JUVÉDERM® were mild in severity and consistent with known safety profile.1 Additional data from the clinical study will be submitted for presentation at a future medical congress and for publication.
"Patients express frustration about the visible changes in their neck due to aging and sun exposure and seek non-surgical treatment options to address them," said Jeanine Downie, MD, FAAD, board-certified dermatologist and clinical investigator. "SKINVIVE by JUVÉDERM® may offer another tool for patients exploring their aesthetics treatment journey beyond the face."
About Allergan Aesthetics
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.allerganaesthetics.com
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio.
References
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Data on File. ABVRRTI81230. Allergan Aesthetics, an AbbVie company.
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Data on File. REF-138623. Allergan Aesthetics, an AbbVie company.
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Jones et al. Dermatol Surg. 2016 Sep 26;42(Suppl 1): S235–S242