The US Food and Drug Administration (FDA) has approved Juvéderm Voluma XC (Allergan) to correct age-related volume deficits in the midface in adults aged 21 years and older, the company announced today.
Juvéderm Voluma XC is a viscous gel composed of cross-linked hyaluronic acid suspended in phosphate-buffered saline with 0.3% lidocaine. It is the first dermal filler approved in the United States specifically for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the midface.
As reported by Medscape Medical News, in May 2013, the FDA's General and Plastic Surgery Devices Panel unanimously agreed that Juvéderm Voluma XC is effective and safe and that the benefits outweigh the risks, according to the clinical trial data presented to the panel.
Many panel members noted that the product fills an "unmet need."
"As people age, the cheek area can lose volume, causing the cheeks to flatten out and the skin to droop and sag," Derek H. Jones, MD, said in a company news release announcing the approval. Dr. Jones is associate professor of dermatology at the University of California, Los Angeles; founder and medical director of Skin Care and Laser Physicians of Beverly Hills; and clinical investigator in the Juvéderm Voluma XC pivotal study.
In the study, "physicians and patients were able to see instant and visible results, including correction of age-related volume loss in the cheek area and a more youthful appearance to the face," Dr. Jones said.
The most common adverse effects observed in the clinical trial included temporary injection-site tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. The adverse effects were predominantly moderate (uncomfortable) in severity and lasted 2 to 4 weeks.
Juvéderm Voluma XC will be available this fall, the company said.