Aesthetics products giant Allergan (NYSE:AGN) is poised to add another 1st to its repertoire, as long as U.S. healthcare regulators green-light the company’s Juvederm Voluma XC injectable gel for volume restoration in the mid-face.
If the FDA follows a May 2 advisory panel’s recommendation, Juvederm Voluma XC will be the 1st and only product on the U.S. market specifically approved to restore cheek volume that has been lost over time.
The regulatory watchdog’s General & Plastic Surgery Devices advisory panel last week unanimously voted that the injectable gel is safe and effective and that its benefits outweigh its risks.
Facial fillers are already used off-label for age-related volume deficit in the mid-face, but a regulatory label would be a 1st for the U.S. and could significantly boost Allergan’s position in the facial filler market.
Clinical trial data for Juvederm Voluma XC showed that, while there were some cases where patients had swelling and bruising around the injection site of the facial filler, these were “transient responses which do go away, that are not life threatening, that don’t seem to be particularly important,” said panel chair Dr. Joseph LoCicero of SUNY Downstate in Brooklyn, N.Y.
"[The panel’s] recommendation is an important step in the FDA review process for Juvederm Voluma XC," Allergan chief scientific officer and R&D executive vice president Dr. Scott Whitcup said in prepared remarks. "Allergan is committed to working with the FDA as they continue their review of our PMA for Juvederm Voluma XC, with the goal of providing consumers with the 1st treatment option that has been specifically developed to help restore cheek volume that has been lost over time."
Following an anticipated FDA approval, Allergan expects to launch Juvederm Voluma XC in late 2013.
Concerns and suggestions for future facial filler studies
Although they recommended approval, the panelists expressed concern for the low percentage of patients who developed painful, red swollen nodules as a result of receiving Juvederm Voluma XC during the clinical trial. They noted that this was such an infrequent occurrence (less than 1%), that they felt comfortable recommending approval for the facial filler nonetheless.
The panel further noted that adverse reactions increased in patients who received higher injection volumes (9 mL or greater) of Juvederm Voluma XC, and pointed out that no patients received more than 12 mLs of the facial filler during the trial.
“The panel feels that there are certainly issues with a higher volume of injection, older patients, and also the addition of thin-skinned patients, but the panel also feels that it is important that areas that have not been studied are stated: patients over 65, thin-skinned patients, patients with injections over large volumes (such as 12 mL),” LoCicero said. “This should be handled as a caution to the user of the product.”
The panel generally agreed that, while there is room for improvement in Allergan’s study design for future studies of facial fillers, “the sponsor has done a very good job in developing an instrument, validating that instrument and using that measure to the best of their ability,” LoCicero said. “Possible future studies with other validated instruments might be useful, but that this was certainly the best at the time.”
Future studies of facial fillers could potentially include another type of control, such as a sham saline injection, panelists said.
While the panel felt “uniformly positive” about patients’ response to Juvederm Voluma XC after 6 months, “beyond that point, there is less unanimity in terms of the effectiveness of the product, without further study,” LoCicero noted.
Panelists said that Allergan’s proposed post-approval study for Juvederm Voluma XC is adequate, but suggested that particular attention be paid to potential differences in patients with darker skin, which is thicker.
Patients not studied, such as those over 65 or those with skin conditions like acne, may be interested in the product, too, and Allergan should consider also studying these groups, the panel suggested.