FDA Approves Hyaluronic Acid Injection to Boost Skin Radiance

The FDA approved a minimally invasive, long-acting hyaluronic acid (HA) intradermal microdroplet injection (Skinvive by Juvéderm; AbbVie) to improve skin smoothness of the cheeks in adults aged 21 years and older, according to Allergan Aesthetics in a recent press release. At 6 months of treatment, 83% of patients were satisfied with the health of their facial skin, according to results from a pivotal clinical study that evaluated the gel.

"Skin quality is among the top concerns my patients express when seeking aesthetic treatments,” said study lead investigator and author Macrene Alexiades, MD, PhD, US and EU board-certified dermatologist, in the press release. “It's an extremely important factor I consider in my therapeutic process of restoring their natural beauty and appearance."

Investigators conducted a randomized, multicenter, evaluator-blinded, controlled pivotal clinical study to evaluate HA intradermal microdroplet injection in 124 patients. At 6 months of optimal treatment:

• 56% of patients reported a 1 point or greater improvement on the Allergan Cheek Smoothness Scale (ACSS).
• 63% reported satisfaction with facial skin radiance compared with 11% before treatment.
• 72% reported satisfaction with facial skin hydration compared to 24% before treatment.
• 69% reported satisfaction with how refreshed their facial skin made them look, compared to 16% before treatment.

HA intradermal microdroplet injection is a smooth, injectable HA gel with lidocaine that smooths the skin of the cheek and increases hydration. Hydration is a key factor in improving skin quality, Alexiades said. The gel is also approved for all Fitzpatrick Skin Types (I-VI, lightest to darkest), addressing an unmet need in skin quality assessments.

The most reported adverse events (AEs) included mild to moderate redness, lumps/bumps, swelling, bruising, pain, tenderness, firmness, discoloration and itching that likely resolved within 7 days. Mild events caused little discomfort and did not affect daily activities, whereas moderate events affected daily activities. There were few severe events or reports of needle abrasion and papule at the injection site.

HA intradermal microdroplet injection is the newest addition to AbbVie’s portfolio of HA products, which includes hyaluronic acid gel (Juvéderm Collection of Fillers) and topicals (SkinMedica) according to Carrie Strom, president of Global Allergan Aesthetics and senior vice president of AbbVie.

HA treatment is minimally invasive, offers little to no downtime, and provides results that can last 6 months without the need for recurring treatments. The results of the clinical trial were published in Dermatologic Surgery.

“HA intradermal microdroplet injection is truly innovative because it works beneath the skin's surface to increase skin hydration improving skin quality,” Alexiades said in the press release. “I am excited to add this unique offering to my dermatologic treatment regimen for my patients."

Reference

AbbVie. Skinvive™ by Juvéderm® Receives U.S. FDA Approval. News Release. May 15, 2023. Accessed on May 16, 2023. https://news.abbvie.com/news/press-releases/skinvive-by-juvderm-receives-us-fda-approval.htm