Voluma, a Unique New Filler, Gets FDA Approval
Can you hear the Champagne glasses clinking? Allergan, the company that brought us Botox, now hopes to be indispensible to our cheeks. After a North American study involving 235 patients, Juvéderm Voluma XC—Voluma for short—is the first filler approved by the FDA to claim it can “temporarily correct age-related volume loss in the cheek area of adults over the age of 21.” [Source: Allure]
Cosmetic doctors in the U.S. have been waiting almost five years for the aptly named Voluma, a hyaluronic acid, or HA. It is already approved in 72 countries, where doctors have found it works particularly well restoring volume to cheeks. One of the early signs of aging is volume loss in that part of the face from a combination of fat and bone absorption, which results in sagging skin and hollowing that increases slowly over time. Another quality unique to Voluma is that it can last for two years—exceptional longevity for an HA—and something that makes it particularly appealing to patients who dislike returning for frequent refills. According to Derek H. Jones, a Beverly Hills dermatologist and the lead investigator in the study, “Voluma lasted in cheeks for up to two years,” at least twice the endurance of Restylane.
Juverderm Voluma in Atlanta
Most other fillers are approved for injection in the nasolabial folds, a.k.a. smile lines. Injection in other areas is allowed, but considered off-label. Voluma gel contains lidocaine to numb pain and is meant to be injected at a deep level, on top of the cheek bones. Side effects observed in the clinical trial included mild to moderate tenderness, swelling, firmness, lumps and bumps, bruising, pain, redness, discoloration, and itching that lasted for seven days or less. These are unlikely to deter patients concerned with sinking and sagging cheeks. What may deter some, though, is the price: Jones estimates that a one-cc syringe of Voluma could be priced by physicians at around $1,000. Study patients, who were obviously chosen for visible loss of volume, required an average of six ccs each. But Jones believes a typical patient will need only two to four syringes. Considering how long Voluma lasts, he told me, it gives “a lot of bang for the buck.”