FDA Reviews sPMA Application for Hyaluronic Acid Injectable to Improve Neck Appearance

The U.S. Food and Drug Administration (FDA) has accepted for review a supplemental premarket approval (sPMA) application for SKINVIVE by JUVÉDERM® (Allergan Aesthetics, an AbbVie company), expanding its potential use to include treatment of horizontal neck lines in adults. The product is currently approved in the United States for improving cheek skin smoothness in individuals aged 21 and older.

SKINVIVE by JUVÉDERM® is an intradermal injectable formulation of hyaluronic acid, a naturally occurring glycosaminoglycan involved in skin hydration and structural support. The sPMA submission is based on results from a multicenter, evaluator-blinded, randomized controlled trial evaluating the product’s safety and efficacy for moderate to severe horizontal neck lines.

According to a press release, the study met all primary and secondary endpoints. At 1-month post-treatment, 80% of participants receiving SKINVIVE by JUVÉDERM® achieved at least a 1-grade improvement in horizontal neck lines based on investigator assessment. Nearly 90% of treated patients also reported improved neck appearance on the Global Aesthetic Improvement Scale. Patient-reported outcomes using the FACE-Q instrument indicated a significant reduction in dissatisfaction with neck appearance among treated individuals compared with controls. Treatment-emergent adverse events were mild and aligned with the product’s known safety profile.

Aesthetic concerns related to the neck are increasingly common, with many patients seeking minimally invasive solutions. If approved, SKINVIVE by JUVÉDERM® would represent the first hyaluronic acid–based injectable in the U.S. specifically indicated for reducing neck lines.

"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."

The product is part of Allergan Aesthetics’ broader portfolio, which includes botulinum toxin and topical skincare products. The company indicated that further clinical data from the neck treatment study will be submitted for peer-reviewed publication and presented at an upcoming medical conference.

The FDA’s review of the sPMA is ongoing, with no projected timeline for a decision disclosed.