09 Jun FDA Approves a New Filler
The FDA Just Approved a New Filler That’s the First of Its Kind
By Julie Ricevuto, Digital Beauty Editor | March 20, 2017
This article originally appeared on newbeauty.com. To view the full article, click here.
Allergan, the pharmaceutical company behind Juvéderm, just announced some pretty exciting news: One of its new fillers has been granted FDA-approval. The filler, called Juvéderm Vollure XC, is now the first and only hyaluronic acid dermal filler approved for the correction of moderate to severe wrinkles and folds (such as nasolabial folds) that lasts up to 18 months in people over the age of 21.
The news of this approval comes after an exciting clinical trial featuring the filler came to a close, revealing some promising findings. According to the trial, 59 percent of subjects saw improvement in nasolabial folds for up to 18 months, a substantial finding considering that most fillers typically last only about a year. Additionally, patient satisfaction in the study was also significant, with 82 percent of patients saying they were very satisfied after six months and 68 percent still claiming satisfaction at 18 months.
Juvéderm Vollure XC features the same Vycross technology that Juvéderm Voluma XC (the filler used to plump the cheek area) and Juvéderm Volbella XC (the filler used in lip augmentation) uses. However, this time the Juvéderm Vollure XC is FDA-approved to use the Vycross technology in the nasolabial folds, which also happens to be the number-one dermal treatment area.
“What’s exciting about Juvéderm Vollure XC is that it was shown to last up to 18 months from the initial or touch-up injection in a majority of subjects, which is the longest-lasting result shown in a clinical study in the nasolabial folds,” said Dr. Joely Kaufman, a board-certified dermatologist and clinical trial investigator, in a press release. This development is major news for many physicians who inject fillers into the nasolabial folds on a daily basis, but are looking for a filler that can provide results in the area for a longer time period.
Juvéderm Vollure XC has been approved in Europe since 2013 under the name Juvéderm Volift and has been met with success in more than 80 countries outside of the U.S. since then. Juvédern Vollure XC will be available to U.S.-based physicians in April 2017.