U.S. FDA Accepts Allergan Aesthetics’ Premarket Approval Application For SKINVIVE By JUVÉDERM® To Improve Neck Appearance

Allergan Aesthetics, an AbbVie company, has announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental premarket approval (sPMA) application for SKINVIVE by JUVÉDERM®. The application seeks approval for the product to reduce neck lines and enhance the appearance of the neck. Currently, SKINVIVE by JUVÉDERM® is approved in the U.S. to improve the smoothness of the cheeks in adults over the age of 21.

Improving neck appearance has become a growing concern for individuals seeking aesthetic treatments, with many exploring professional options to address visible neck lines. If approved, SKINVIVE by JUVÉDERM® could become the first hyaluronic acid-based injectable treatment specifically targeting neck lines.

The sPMA submission is backed by data from a multicenter, randomized, evaluator-blinded clinical study. The trial involved adults with moderate to severe horizontal neck lines who were seeking cosmetic improvement. The study met all its primary and secondary endpoints. According to investigators, 80% of patients treated with SKINVIVE by JUVÉDERM® showed at least a one-grade improvement in neck lines by the end of the first month. Additionally, nearly 90% of participants reported improved neck appearance as evaluated by the Global Aesthetic Improvement Scale.

Darin Messina, Ph.D., senior vice president, aesthetics R&D, AbbVie, stated, "SKINVIVE by JUVÉDERM® is an injectable version of hyaluronic acid, a naturally occurring molecule found in the skin and important for skin hydration. 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®."

Jeanine Downie, MD, FAAD, board-certified dermatologist and clinical investigator, mentioned, "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. SKINVIVE by JUVÉDERM® may offer another tool for patients exploring their aesthetic treatment journey beyond the face.”

Patients also reported feeling significantly less self-conscious about the appearance of their necks after treatment, based on results from the FACE-Q questionnaire. In contrast, the control group did not report any significant changes. Adverse events observed in the treatment group were mild and consistent with the known safety profile of the product. Further findings from this clinical study are expected to be presented at an upcoming medical conference and submitted for publication.