FDA panel supports injectable midface filler
AT AN FDA ADVISORY COMMITTEE MEETING
GAITHERSBURG, MD. – A Food and Drug Administration advisory panel unanimously recommended approval of an injectable filler specifically for use in the midface.
At a May 2 meeting, the members of the FDA’s General and Plastic Surgery Devices Panel supported approval of Allergan’s Juvéderm Voluma XC (Voluma) for the correction of age-related volume loss in the midface. The FDA usually follows the recommendations of its advisory panels, which are not binding.
The meeting was held for the panel to discuss, make recommendations, and vote on information related to the premarket approval application for Voluma. Voluma is a biodegradable dermal filler that combines low- and high-molecular-weight hyaluronic acid (20 mg/mL) and 0.3% lidocaine in phosphate-buffered saline.
This new formulation distinguishes Voluma from other injectable products, noted Joseph Nielsen, Ph.D., a biologist with the FDA’s Center for Drug Evaluation and Research.
Voluma’s combination of high- and low-molecular-weight hyaluronic acid creates a thicker product with a jamlike consistency that is designed for deeper injections, said Dr. Rui Avelar, chief medical officer for Allergan. Voluma is indicated specifically for deep injections (subcutaneous and/or supraperiosteal) to correct age-related volume loss in the midface. No products are currently approved in the United States for this indication, although Voluma is approved in 65 countries, including Canada and Australia.
The approval was based on data from a randomized clinical trial. The study population included adults aged 35-65 years (mean age, 55 years). Approximately 80% of the patients were women, more than half were white, and 44% were Fitzpatrick skin types IV, V, and VI. A total of 235 patients were randomized to immediate treatment with Voluma, and 47 served as nontreatment controls to receive injections 6 months later; 208 treatment patients and 36 nontreatment controls had complete data for evaluation at 6 months.
Primary effectiveness was based on the blinded live evaluation of two investigators using the Mid-Face Volume Deficit Scale (MFVDS), a 0-5 point scale approved and validated for the study. Significant response was defined as at least a 1-point change in the MFVDS. In addition, three-dimensional imaging was used to assess changes in volume. Imaging data were not collected from nonresponders.