FDA Reviews Allergan's Approval Application for SKINVIVE to Enhance Neck Appearance

FDA Reviews Allergan's Approval Application for SKINVIVE

Allergan Aesthetics, now a part of AbbVie, has announced that the U.S. Food and Drug Administration (FDA) is reviewing their supplemental premarket approval (sPMA) application for SKINVIVE by JUVÉDERM®. This innovative treatment is designed to reduce neck lines and enhance the overall aesthetic of the neck area, an area of concern for many individuals seeking aesthetic enhancements.

Background of SKINVIVE by JUVÉDERM®

SKINVIVE by JUVÉDERM® is already recognized as the first and only injectable hyaluronic acid microdroplet treatment approved in the U.S. for improving the smoothness of cheek skin. If the FDA grants approval for the new application, SKINVIVE will become the first hyaluronic acid injectable specifically targeted for improving neck appearance by reducing visible neck lines.

Dr. Darin Messina, senior vice president of aesthetics RD at AbbVie, stated, "This submission reinforces our commitment to developing innovative solutions for comprehensive treatments tailored to the lower face and the neck, further complimenting our existing portfolio that includes market leaders like BOTOX Cosmetic® and SkinMedica®."

Significance of Neck Treatments

Neck aesthetics have increasingly become a focal point for many consumers, with millions seeking professional treatments to address signs of aging and sun exposure. According to market research, a substantial number of individuals are considering non-surgical options to manage visible neck aging. This growing market underscores the importance of the SKINVIVE application as a potential first-line treatment.

The FDA’s review is supported by clinical studies that met all primary and secondary endpoints. The study involved adults with moderate to severe horizontal neck lines who sought improvements in their neck area's appearance. Results showcased that 80% of participants experienced at least a one-grade improvement in their neck lines just one month after treatment with SKINVIVE. Furthermore, nearly 90% of patients reported enhanced neck appearance based on the Global Aesthetic Improvement Scale. These promising outcomes indicate that SKINVIVE by JUVÉDERM® could significantly impact the aesthetic landscape, particularly for those frustrated with age-related neck changes.

Clinical Study Outcomes

The applicant's commitment to safety is demonstrated through their multicenter, evaluator-blinded, randomized controlled study. This comprehensive examination quantified treatment-emergent adverse events, which were predominantly mild and aligned with the known safety profiles of similar injectables. Continuous monitoring and further data analysis will follow as part of their commitment to transparency and patient safety, which will also be presented at upcoming medical congresses.

"Many patients express frustration regarding visible neck aging and seek out effective, non-surgical solutions," noted Dr. Jeanine Downie, a board-certified dermatologist involved in the clinical study. "The advent of SKINVIVE by JUVÉDERM® could offer new possibilities for individuals during their aesthetic treatment journeys, especially for concerns beyond the facial domain."

Important Considerations

Despite the positive findings, potential patients are advised to be aware of safety considerations. The most frequently reported side effects from similar treatments include redness, swelling, and tenderness at the injection site, all of which typically resolve within a week. Allergan also emphasizes the importance of consulting with qualified practitioners to address any personal health concerns, especially for those with existing medical conditions or histories of allergic reactions.

In conclusion, the FDA’s acceptance of Allergan’s application marks a pivotal moment for the aesthetic medical field, where SKINVIVE by JUVÉDERM® might soon become a cornerstone treatment for neck aesthetics. As further developments unfold, it will be critical for both practitioners and consumers to stay informed about efficacy, safety, and the evolving landscape of aesthetic treatments.

For more information about SKINVIVE and other Allergan products, please visit their official site or consult with your aesthetic practitioner.