Premarket approval application for Skinvive by Juvederm for neck lines reduction under USFDA review: Abbvie Allergan Aesthetics
Irvine: AbbVie's Allergan Aesthetics has announced that the U.S. Food and Drug Administration (FDA) has 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. SKINVIVE by JUVÉDERM could offer 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. All primary and secondary endpoints were met. 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. 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. 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. Treatment-emergent adverse events for SKINVIVE by JUVÉDERM were mild in severity and consistent with known safety profile. 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."
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