The U.S. Food and Drug Administration (FDA) has accepted for review a supplemental premarket approval application from Allergan Aesthetics, an AbbVie company, for the product SKINVIVE by JUVÉDERM. The application seeks to expand the indication of this injectable hyaluronic acid treatment to reduce neck lines, thereby improving neck appearance.
Currently approved in the United States for enhancing cheek skin smoothness in adults over 21, SKINVIVE by JUVÉDERM could become the first hyaluronic acid injectable aimed specifically at reducing neck lines if approved. Darin Messina, Ph.D., senior vice president of aesthetics research and development at AbbVie, remarked that "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."
The application is backed by a clinical study that successfully met all primary and secondary endpoints concerning adults with moderate to severe horizontal neck lines. According to the study's findings, 80% of patients treated with SKINVIVE by JUVÉDERM experienced at least a one-grade improvement in their neck lines within one month. Additionally, nearly 90% reported improvements as per the Global Aesthetic Improvement Scale.
Jeanine Downie, MD, FAAD, board-certified dermatologist and clinical investigator noted that "patients express frustration about the visible changes in their neck due to aging and sun exposure," adding that "SKINVIVE by JUVÉDERM may offer another tool for patients exploring their aesthetics treatment journey beyond the face."
SKINVIVE by JUVÉDERM is designed as an intradermal injection for improving facial skin smoothness but includes specific safety information regarding its use. Patients are advised against using it if they have certain allergies or medical conditions such as severe reactions or multiple allergies.
Allergan Aesthetics markets a range of aesthetic products including BOTOX Cosmetic and SkinMedica. Their portfolio reflects ongoing efforts to innovate within aesthetic treatments.
For further details on potential side effects or precautions associated with SKINVIVE by JUVÉDERM or BOTOX Cosmetic treatments, consumers are encouraged to consult healthcare providers or visit relevant websites.