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FDA approves Juvéderm Voluma XC for age-related loss in cheeks
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The FDA has approved Juvéderm Voluma XC as a filler to temporarily correct age-related loss in the cheeks of patients aged 21 years and older, Allergan has announced.
Juvéderm Voluma XC is an injectable, viscous gel composed of cross-linked hyaluronic acid suspended in phosphate-buffered saline with 0.3% lidocaine indicated for deep injection in the cheek to correct volume loss.
The FDA’s approval was based on data from a clinical trial conducted by Allergan in the United States and Canada that measured the safety and efficacy of the product as a nonsurgical option for patients seeking to correct age-related volume loss in the cheek, according to a press release.
“The trial demonstrated that Juvéderm Voluma XC was an effective treatment compared to the control group, which did not receive treatment,” the release said.
Trial side effects, which lasted 2 to 4 weeks, included temporary injection-site tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration and itching.
“As people age, the cheek area can lose volume, causing the cheeks to flatten out and the skin to droop and sag,” researcher Derek H. Jones, MD, associate professor of dermatology, University of California, Los Angeles, said in the release. “In the trial, 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.”
Juvéderm Voluma without lidocaine was released in Europe in 2005, and Juvéderm Voluma with lidocaine was introduced outside the United States in 2009, Allergan reported. Juvéderm Voluma XC will be available later this year, according to the release.