Galderma announced in December 2016 that it had released next-generation flexible hyaluronic acid (HA) dermal fillers Restylane Refyne and Restylane Defyne to the U.S. marketplace.
The filler duo, which has been used in the UK under the names Emervel Classic (Refyne) and Emervel Deep (Defyne), were approved by the FDA for treatment of moderate-to-severe facial wrinkles and folds. Defyne’s distinction is that it’s for deep wrinkles and folds.
Galderma is promoting the fillers’ technology, called XpresHAn, which results in a smooth, injectable gel that offers a range of flexibility and support. The aim is to look natural regardless of patients’ facial expressions. According to Galderma, Refyne is designed to be very flexible and provide subtle support, while Defyne is designed to be less flexible and provide additional support. Company data show the fillers last in laugh lines for up to a year.
In two phase 3 studies on Refyne and Defyne, involving a total of 333 subjects, study investigators measured outcomes with the Wrinkle Severity Rating Scale, a 5-point measure of a wrinkle’s size and depth. Grade 1 is the absence of wrinkles and grade 5 means wrinkles are very deep and long. Nearly 80% of Refyne subjects and 77% of Defyne had at least a one-grade improvement after six weeks.
Side effects from the two fillers, including redness, swelling, bruising, lump or bump formation, pain and tenderness, were generally mild and transient — usually lasting up to two weeks.
Whether Refyne and Defyne or Allergan’s newer Juvéderm fillers Vollure XC and Volbella XC are going to make their marks among physician injectors and patients remains to be seen, Joe Niamtu, III, DMD, an oral and maxillofacial surgeon with a practice limited to cosmetic facial surgery in Richmond, Va., tells Cosmetic Surgery Times.
“Galderma is saying that its fillers work better in areas of movement. Allergan has introduced a few fillers, as well,” Dr. Niamtu says. “I think most of these fillers are very similar in indication and use but [according to] the companies, more technologically advanced in terms of stability and longevity.”
Midrange Fillers vs Game Changers
Juvéderm’s Voluma XC (Allergan) was more of a game changer, according to Dr. Niamtu.
“It really acted differently than the other fillers with a lot of lift and a little bit went a long way. The longevity also was superior,” he says.
Dr. Niamtu says that as more fillers are introduced, market forces will likely weed out some products, while others rise to the top.
“For the experienced injector, having a lot of choices may be a good thing. People who have large injectable filler practices can use multiple options and have big inventories,” he says. “But, for your mom and pop injectors, you can’t have six filler choices from each company. It’s not cost-effective.”
In the Galderma line, Dr. Niamtu says he uses Refyne for wrinkles around the mouth and Defyne for nasolabial folds. His go-to filler for those areas used to be Restylane or Juvéderm Ultra Plus. Some fillers are specifically engineered for extremely superficial wrinkles, such as Volbella XC and Restylane Silk. Others are more designed for lifting or supporting, such as Voluma and Restylane Lift (formerly, Perlane). The new midrange fillers, include Refyne and Defyne, he says.
“In all honesty, what drives patient requests for a lot of fillers in my practice is what kind of rebate the patient will get from the company,” he says. “It is a confusing time [for patients and providers], but time and doctor-patient experience will prevail. My challenge to these companies if they want to promote their products correctly is through evidence-based studies to be able to precisely show the best anatomical uses for each filler. Otherwise, a lot of confusion will exist on what to use where.”