
Aesthetics company Allergan (NYSE:AGN) notched a U.S. market 1st with FDA approval for its Juvederm Voluma XC facial filler, the only filler indicated for age-related volume restoration in the cheeks.
Juvederm Voluma XC has been available around the world since August 2013 and should be on shelves in the U.S. before the end of the year, according to Allergan.
The news didn’t seem to stir much reaction from Wall Street, where AGN shares were relatively flat through the morning. The stock was down 0.4% to $91.40 as of about 12:20 p.m.
Facial fillers are already used off-label for age-related volume deficit in the mid-face, but the FDA’s seal of approval is 1st for the U.S. and stands to significantly boost Allergan’s position in the facial filler market.
"We are pleased that the FDA has now approved Juvederm Voluma XC, the 1st product of its kind specifically formulated to correct age-related volume loss in the cheek area," Allergan chief scientific officer and R&D executive vice president Dr. Scott Whitcup said in prepared remarks. "Juvederm Voluma XC represents the latest innovation in Allergan’s growing portfolio of facial aesthetic products developed to address previously unmet patient needs."
FDA approval was based in part on clinical results from Allergan’s pivotal trial, which showed limited concerns about adverse events, such as swelling and bruising around the injection site of the facial filler. Those reactions were deemed "transient responses which do go away, that are not life threatening, that don’t seem to be particularly important," according to a member of the May 2013 FDA advisory panel for the Juvederm Voluma XC. That panel voted unanimously that the injectable gel is safe, effective and that its benefits outweigh its risks.