Juvéderm Volbella XC is said to be the first and only dermal filler to receive FDA approval for the improvement of infraorbital hollows

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AbbVie corporate headquarters. (Credit: AbbVie Inc.)

Allergan Aesthetics, a company of AbbVie, has received the US Food and Drug Administration (FDA) approval for Juvéderm Volbella XC to improve infraorbital hollows in adults older than 21 years.

In addition, the company is offering a product training programme to all interested providers, through its Allergan Medical Institute (AMI).

The training will include facial anatomy and considerations for safe injections, along with ways to identify and manage potential complications of treatment.

The company said the completion of the training is necessary before the administration of Juvéderm Volbella XC for the new indication.

Juvéderm Volbella XC was initially approved by the US FDA in 2016 for use in the lips and perioral rhytids.

According to Allergan Aesthetics, its Juvéderm Volbella XC is the first and only dermal filler to receive FDA approval for the improvement of infraorbital hollows.

With the regulatory approval in the new indication, the company is expected to expand its aesthetic treatment portfolio to better address unmet patient needs.

Allergan Aesthetics president and AbbVie senior vice president Carrie Strom said: “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.

“Allergan Aesthetics offers the broadest portfolio of treatment options designed to address the delicate eye area from topical skincare 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 per the clinical trial data, 90% of subjects reported satisfaction, one year after treatment, said the company.

In the clinical studies, the treatment met the primary effectiveness criteria of 83.1% and was statistically significantly greater than the responder rate for the control group of 15.6%.

The treatment showed a clinically significant mean improvement, with the majority of subjects experiencing the improvement within one year.

Most common side effects include tenderness to touch, bruising, swelling, lumps/bumps, redness, pain after injection, firmness, discolouration, or itching.

Furthermore, the training at AMI will also educate providers on assessing holistic facial anatomy, where Juvéderm Voluma XC may be added to address volume loss in the midface.

The safety and efficacy of Juvéderm Voluma XC and Juvéderm Volbella XC combination has not been validated, said the company.

AMI trainer, board-certified oculofacial plastic surgeon and ophthalmologist Julie Woodward said: “The approval of Juvéderm Volbella XC is a milestone in offering providers, like myself, a safe and effective treatment option to address the undereye area for my patients.

“The characteristics of Juvéderm Volbella XC with lower amounts of hyaluronic acid molecules and low water affinity provides a soft, smooth formulation appropriate for treating undereye hollows.

“The results of the clinical trial demonstrate significant improvements in the appearance of undereye hollows and overall appearance.”