FDA panel recommends Juvéderm Voluma XC for cheek augmentation

The FDA’s General and Plastic Surgery Devices Panel Advisory Committee recommended in May that Allergan’s Juvéderm Voluma XC is safe and effective as an injection for cheek augmentation to correct midface age-related volume deficit.

Perspective from

“Because there are no permanent adverse reactions or deforming reactions, I think the safety is assured,” Karen E. Burke, MD, of New York, a temporary voting member of the panel, said. “I think that we’ve seen by the criteria measured … that [Juvéderm Voluma XC] was effective. … The benefits do outweigh the risk, and I think there is a need to have an FDA-approved material for this indication of volume enhancement, since we have many FDA-approved things for wrinkle enhancement.”

The product is a viscous gel composed of cross-linked hyaluronic acid suspended in phosphate buffered saline with 0.3% Lidocaine indicated for deep (subcutaneous and/or supraperiosteal) injection in the cheek. Results of a clinical study using the product were presented to the panel because dermal filler use in the midface is a significant new indication, the FDA stated.
The study took place at 15 investigational sites, with two evaluating investigators. Two-hundred eighty-two patients (mean age, 54.4 years; 80.1% women; 58.5% Caucasian) were randomly assigned to a treatment group (n=235) or control group (n=47), with initial treatment between Aug. 26, 2009, and June 17, 2010. Up to two treatments of Juvéderm Voluma XC were given, with appropriate volume determined by the treating investigator, up to a maximum of 12 syringes (12 mL). The control group had treatment delayed by at least 6 months.

Post-treatment follow-up included telephone or email contact at day 3, 30-day safety diary and office visits at 1, 3 and 6 months and quarterly intervals up to 24 months after the last treatment.

The evaluating investigators (EI) measured primary effectiveness using the 6-point A Mid-Face Volume Deficit Scale (MFVDS). If patients demonstrated an average improvement (reduction) of at least 1 grade on the MFVDS compared with the average of pre-treatment assessments, they were considered “responders.”

Both primary endpoints were met, with significantly greater than 70% of the treatment group considered responders. The treatment group’s median MFVDS improved from 3.5 to 1.5 at 6 months, compared with controls, whose median score remained 3.0.

The Global Aesthetic Improvement Scale (GAIS) responder rate was assessed at 82.2% at 6 months for the treatment group. At 24 months, EI assessment on the GAIS showed that treatment group patients were primary improved or much improved (69.7% had a score of 1, 1.5.or 2).

At completion of an extended follow-up between 12 and 24 months, an optional repeat treatment was permitted.

“This would be the only semipermanent filler that we would have that has ever been suggested to last 21 months,” temporary board voting member Michael J. Olding, MD, of George Washington University, Washington, DC, said prior to the vote, during a discussion on product labeling. “I would agree that at 6 months, I have no trouble with that whatsoever, but the number of responders steadily decreases over those 21 months.”

“The panel seems to be uniformly positive about the response to 6 months,” temporary panel chair Joseph LoCicero III, MD, of SUNY Downstate, Brooklyn, NY, said in addressing panel concerns to the FDA. “Beyond that point there is less unanimity in terms of the effectiveness of the product without further study.”

Perspective

From the outset we should say that we were one of the study sites for this research. In addition, Juvéderm Voluma has been approved in Canada for over 4 years and during that time we have injected over 7,700 mL of Voluma in approximately 3,000 injection sessions in over 1,300 patients. So we know and understand this product fairly well.

The FDA advisory panel unanimously recommended that Juvéderm Voluma is safe and effective for cheek augmentation and to correct midface age-related volume deficit. This is an important new area for the use of “fillers.” As such, it required all parties involved (Allergan, the FDA, the investigators, the panel) to examine the plan and then the evidence in new ways. For example, one of the first steps was to develop and validate an efficacy scale (the MFVDS) which was sufficiently robust to demonstrate the results of the injections.

Alastair Carruthers

This is a world away from the comparison of two nasolabial folds on different sides of the same person and required skill and training for the investigators.

The treating investigators also had to be trained in a new approach to the face and the concept of restoration by revolumizing. The resoundingly positive results of this study would suggest that all involved did their work well. The study design and success reflects the shift in clinical practice from a 2-D to 3-D approach to “fillers.”

There were no significant long-term adverse events in this study, which was important because the efficacy data suggest that this filler in this location has significantly greater longevity than has been demonstrated with other similar temporary fillers in other locations.

To summarize, the study went into new territory and was able to demonstrate both safety and efficacy for this material for this indication. We anticipate that similar studies will now be done with other fillers for this indication, but the current study has set a high standard for others to follow.

Alastair Carruthers, FRCPC
Clinical professor
Department of dermatology and skin science
University of British Columbia, Vancouver

Jean Carruthers, MD
Clinical professor
Department of ophthalmology
University of British Columbia, Vancouver

Shannon Humphrey, MD
Director of continuing medical education
Department of dermatology and skin science
University of British Columbia, Vancouver

Disclosures: Drs. Alastair Carruthers, Jean Carruthers and Shannon Humphrey are consultants to and investigators for Allergan.