FDA Panel Gives Unanimous Thumbs-Up to Cheek Volume Filler

Megan Brooks

May 02, 2013

A US Food and Drug Administration (FDA) panel today unanimously recommended that the agency approve Juvéderm Voluma XC (Allergan) to correct age-related volume deficits in the mid-face.

Juvéderm Voluma XC is a viscous gel composed of cross-linked hyaluronic acid suspended in phosphate buffered saline with 0.3% Lidocaine.

If approved, it would be the first dermal filler approved in the US specifically for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face.

Unmet Need

Based on the clinical trial data presented, the FDA's General and Plastic Surgery Devices Panel unanimously agreed that Juvéderm Voluma XC is effective and safe and the benefits outweigh the risks.

Many panel members and several speakers during the open public hearing noted that the product fills an "unmet need."

Lawrence C. Green, representing the American Society for Dermatologic Surgery (ASDS), said the society is "very supportive" of the product. He also noted that in 2012 nearly 2 million people had soft tissue filler augmentation, representing a 205% increase since 2000.

The FDA reviewers noted that Juvéderm Voluma XC met the prespecified primary endpoint and the secondary endpoints in the clinical trial, supporting the product's effectiveness.

"FDA concludes the balance of the evidence indicates that Juvéderm Voluma XC is effective in correcting volume deficit in the mid-face at the 6-month primary effectiveness time point," they write.

The most frequent common treatment site responses (CTRs) reported by subjects in the clinical trial were tenderness, swelling, and firmness. CTRs lasted 15 to 30 days in 24.6% of subjects.

The FDA reviewers noted that the incidence of CTRs decreased for subjects receiving touch-up and repeat treatments. More than half (52.8%) of subjects received the optional retreatment at the end of the extended follow-up period "suggesting these subjects perceived an acceptable benefit/risk profile for the continued use of Juvéderm Voluma XC," the reviewers said.

The panel agreed. Panel member Pierre M. Chevray, MD, board certified plastic surgeon from Methodist Hospital, Houston, Texas, noted that none of the reactions were "life-threatening or long-term and all were reversible."

The FDA usually follows advisory committee recommendations, although it is not required to do so.