FDA Approves Juvéderm Volbella XC for Undereye Hollows
Posted By American Med Spa Association, Thursday, February 10, 2022
Allergan Aesthetics, an AbbVie company, announced that the FDA has approved Juvéderm Volbella XC for infraorbital hollow improvement for patients over the age of 21. The clinical trial (NCT03418545) found that 90% of patients reported satisfaction through 1 year after receiving treatment. The FDA requires that Allergan Aesthetics provide a product training program for all interested providers, which will include facial anatomy and considerations for safe injections in this area, as well as how to identify and manage potential complications of treatment. This training must be completed successfully before use of Juvéderm Volbella XC in this new indication.
"This additional indication for Juvéderm Volbella XC demonstrates Allergan Aesthetics' continued commitment to innovation. The eye area, including the undereye hollow, is a top concern among patients," said Carrie Strom, president, global Allergan Aesthetics and senior vice president, AbbVie. "Allergan Aesthetics offers the broadest portfolio of treatment options designed to address the delicate eye area from topical skin care with SkinMedica, to crow's feet lines with Botox Cosmetic (onabotulinumtoxinA) and now, with this approval, the infraorbital hollows, commonly referred to as tear troughs, with Juvéderm Volbella XC."
As the Juvéderm collection of fillers continues to grow, Allergan Aesthetics will continue to train providers through the Allergan Medical Institute (AMI). The press release states, “During the required infraorbital hollows training, providers will be educated on how to assess facial anatomy holistically where for Juvéderm Volbella XC may be added as part of a treatment plan to address volume loss in the midface.” They also noted that the safety and efficacy of combined use for Juvéderm Voluma XC and for Juvéderm Volbella XC has not been studied. The required training can be accessed and completed at VolbellaTraining.com.
Read more at Dermatology Times >>
"This additional indication for Juvéderm Volbella XC demonstrates Allergan Aesthetics' continued commitment to innovation. The eye area, including the undereye hollow, is a top concern among patients," said Carrie Strom, president, global Allergan Aesthetics and senior vice president, AbbVie. "Allergan Aesthetics offers the broadest portfolio of treatment options designed to address the delicate eye area from topical skin care with SkinMedica, to crow's feet lines with Botox Cosmetic (onabotulinumtoxinA) and now, with this approval, the infraorbital hollows, commonly referred to as tear troughs, with Juvéderm Volbella XC."
As the Juvéderm collection of fillers continues to grow, Allergan Aesthetics will continue to train providers through the Allergan Medical Institute (AMI). The press release states, “During the required infraorbital hollows training, providers will be educated on how to assess facial anatomy holistically where for Juvéderm Volbella XC may be added as part of a treatment plan to address volume loss in the midface.” They also noted that the safety and efficacy of combined use for Juvéderm Voluma XC and for Juvéderm Volbella XC has not been studied. The required training can be accessed and completed at VolbellaTraining.com.
Read more at Dermatology Times >>