UPDATED…We all knew this day was coming. and it’s finally here. Allergan Inc’s Juvéderm Voluma™ XC is now officially approved by the federal Food and Drug Administration (FDA).
Juvéderm Voluma™ XC is now the only soft-tissue filler in the US to be the approved to temporarily correct age-related volume loss in the cheek area in adults over the age of 21. It has been approved in Canada and Europe for years. Juvéderm Voluma™ XC will be available in fall 2013.
Plastic Surgery Practice editorial advisory board member Joe Niamtu IIII, DMD, is familiar with the new filler. “The FDA approval of the new filler Juvéderm Voluma™ XC is exciting as it represents a unique situation where a specific filler was developed for a very specific treatment application,” says Niamtu, a cosmetic surgeon in Midlothian Va. “Juvéderm Voluma™ XC was developed and FDA approved specifically for cheek and midface lifting. The properties of Voluma will provide significant G prime, which equates to viscosity and lifting ability.”
He adds that it has also shown to have “excellent longevity” in the clinical trials. “Midface filler augmentation has become very popular with doctors and patients, and it is great to have yet another tool in our bag of tricks,” he says.
Florida facial plastic surgeon Rich Castellano, MD, was excited to be one of the first offices in his area to demo the new filler. “Voluma is a longer-lasting Hyaluronic acid that will be a welcome addition for patients that like immediacy, reversibility, and longevity,” he says. “Juvéderm Voluma™ XC is very comfortable to inject, and will be a definite upgrade for patients wanting more duration than Juvéderm Ultra XC. Voluma can help Juvéderm confidently step beyond the 1-year longevity mark, getting closer to the longevity of Sculptra and Artefill,” he says. ” Voluma XC is sure to be a big hit with cosmetic filler patients,” he predicts.
“I am extremely excited about the availability of a dedicated midface restoration tool,” says Plastic Surgery Practice editorial advisor Julius Few, MD, clinical associate, The University of Chicago Pritzker School of Medicine, Plastic Surgery; Founder, The Few Institute for Aesthetic Plastic Surgery; and Investigator in the Juvéderm Voluma™ XC Clinical Study. “Juvéderm Voluma™ XC will help to not only restore and balance our patients, but it will also focus the physicians’ attention to a much-needed area.”
According to Allergan, Juvéderm Voluma™ XC is made with proprietary VYCROSS™ technology, a manufacturing process that results in a smooth gel that flows easily and consistently. This unique formulation contributes to the lift capacity to correct volume loss in the cheek area and to the duration of the product. Additionally, Juvéderm Voluma™ XC contains a small amount of lidocaine to numb the treatment area during the injection procedure.
Common side effects observed in the clinical trial included temporary injection-site tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching that were predominantly moderate in severity and lasted for 2 to 4 weeks.