The U.S. Food and Drug Administration (FDA) will 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.
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 one. Nearly 90% of patients treated with Skinvive by Juvéderm reported improvement in neck appearance at Month one 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 the 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,” says Clinical InvestigatorJeanine Downie, MD, Director of Image Dermatology PC in Montclair, NJ, and Assistant Attending at Mountainside and Overlook Hospitals. “Skinvive by Juvéderm may offer another tool for patients exploring their aesthetics treatment journey beyond the face.”
