FDA Reviews sPMA to Expand SKINVIVE by Juvéderm for Neck Line Treatment

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Allergan Aesthetics, and AbbVie company, announced today that the US FDA has accepted for review its supplemental premarket approval (sPMA) application for SKINVIVE by Juvéderm.¹

Currently approved in the US for enhancing cheek smoothness in adults aged 21 and older,² the application's approval would expand its scope to also include the treatment of neck lines and improvement of overall neck appearance in adults.

The move reflects growing demand among patients and providers for comprehensive lower face and neck solutions that do not require surgery. According to Allergan Aesthetics, millions of individuals actively seek professional treatments to improve their neck appearance, and neck lines consistently rank among the top aesthetic concerns.³

The FDA’s decision to review the application is backed by data from a multicenter, randomized controlled trial evaluating SKINVIVE’s efficacy and safety in adults with moderate to severe horizontal neck lines.⁴ The evaluator-blinded study met all its primary and secondary endpoints.

Based on investigator ratings, 80% of patients treated with SKINVIVE demonstrated at least a 1-grade improvement in horizontal neck lines after 1 month after treatment. Nearly 90% of participants reported visible improvement in their neck's appearance, as measured by the Global Aesthetic Improvement Scale.

Furthermore, patients receiving treatment with SKINVIVE reported being significantly less bothered by their neck’s appearance post-treatment. These assessments were captured using the FACE-Q questionnaire, a validated tool measuring patient satisfaction with aesthetic outcomes. In contrast, patients in the control group did not report significant changes.

No serious adverse events were reported. Treatment-emergent side effects were generally mild in nature and were consistent with the known safety profile of hyaluronic acid-based injectables.

The findings will be submitted for peer-reviewed publication and presentation at an upcoming medical conference.¹

"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, PhD, senior vice president, aesthetics R&D, AbbVie, in a news release.¹ "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, a board-certified dermatologist and clinical investigator involved in the trial, emphasized the real-world relevance of the treatment.

"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," Downie said.¹ "SKINVIVE by Juvéderm may offer another tool for patients exploring their aesthetics treatment journey beyond the face."

If approved, this would mark the first FDA-approved hyaluronic acid-based injectable aimed specifically at improving the appearance of horizontal neck lines.

References

1. US Food and Drug Administration accepts for review Allergan Aesthetics premarket approval application for SKINVIVE by JUVÉDERM for the improvement of neck appearance. News release. AbbVie. June 30, 2025. Accessed June 30, 2025. https://news.abbvie.com/2025-06-30-U-S-Food-and-Drug-Administration-Accepts-for-Review-Allergan-Aesthetics-Premarket-Approval-Application-for-SKINVIVE-by-JUVEDERM-R-for-the-Improvement-of-Neck-Appearance
2. SKINVIVE by JUVÉDERM receives US FDA approval. News release. AbbVie. May 15, 2023. Accessed June 30, 2025. https://news.abbvie.com/2023-05-15-SKINVIVE-TM-by-JUVEDERM-R-Receives-U-S-FDA-Approval
3. Data on File. REF-138623. Allergan Aesthetics, an AbbVie company.
4. Data on File. ABVRRTI81230. Allergan Aesthetics, an AbbVie company.