SKINVIVE sPMA Accepted for Neck Line Treatment

Key Takeaways:

• Allergan announced that the FDA has accepted the sPMA for SKINVIVE by JUVÉDERM®  hyaluronic acid injectable for the treatment of neck lines.

• The manufacturer reports that the clinical trial met all endpoints with high patient and investigator satisfaction.

• SKINVIVE may become the first hyaluronic acid injectable approved for neck aesthetics.

The U.S. Food and Drug Administration (FDA) has accepted for review a supplemental premarket approval (sPMA) application from Allergan Aesthetics, an AbbVie company, for SKINVIVE by JUVÉDERM® for the treatment of neck lines in adults, according to a press release.

If approved, SKINVIVE would become the first hyaluronic acid injectable with an indication specifically targeting neck line improvement. The sPMA is supported by a randomized controlled trial of adults with moderate to severe horizontal neck lines. The product met all primary and secondary endpoints, according to the manufacturer. Investigator assessments show 80% of treated patients achieved at least a 1-grade improvement in neck lines by the end of month one. Almost 90% of patients reported aesthetic improvement via the Global Aesthetic Improvement Scale. Patient-reported outcomes using FACE-Q also revealed a reduction in perceived bothersomeness of neck appearance post-treatment. Adverse events aligned with SKINVIVE’s known safety profile.

“Patients express frustration about the visible changes in their neck due to aging and sun exposure and seek non-surgical treatment options,” said Jeanine Downie, MD, FAAD, in the news release. “SKINVIVE by JUVÉDERM® may offer another tool for patients exploring their aesthetics treatment journey beyond the face.”