The FDA Just Approved Under Eye Filler For The First Time

Given how much we all talk about the under eye filler, it’s easy to assume that the treatment was already an indication approved by the United States Food and Drug Administration (FDA). But injecting the tear troughs to rejuvenate hollows and minimize the appearance of bags and dark circles has actually been an ‘off label’ use of hyaluronic acid (HA)-based filler. Not any more.

On Tuesday, Allergan Aesthetics announced the FDA approval of Juvéderm® Volbella XC for improvement of infraorbital hollows in adults over the age of 21. “This additional indication… demonstrates Allergan Aesthetics' continued commitment to innovation,” Carrie Strom, president of Global Allergan Aesthetics and senior vice president of AbbVie, said in a press release. So, what does the news mean for your next filler appointment? Here’s what you need to know.

The Popularity of Under Eye Filler

Under eye filler has risen in popularity over the last couple of years, especially as pandemic-related face coverings put more emphasis on the eyes and the stress of everyday life made dark circles, well, darker. “The under eye area is one of the most frequently requested treatment sites among patients, regardless of race and ethnicity, but it is undertreated,” says Julie Woodward, MD, a board certified oculofacial plastic surgeon and ophthalmologist and Allergan Medical Institute (AMI) trainer. “This is in part because it is a sensitive area to inject as it takes great skill and precision.”

The tear troughs are a very delicate area to treat and require unique technique from a highly skilled provider. This approval should help improve the safety and efficacy of the procedure. Per an FDA requirement for this new indication, Allergan Aesthetics will provide training programs, including how to assess facial anatomy holistically and the identification and management of potential complications. Providers will need to complete this training before being allowed to inject Juvéderm® Volbella XC under the eyes.

The Benefits of Under Eye Filler with Juvéderm Volbella XC

Juvéderm® Volbella XC was first approved by the FDA in 2016 for use in the lips and perioral rhytids (a.k.a. the vertical lines that extend from the upper lip). What gives the product a natural look and feel for the lip area extends to the tear troughs. “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 under eye hollows,” Dr. Woodward explains.

Allergan Aesthetics reports that, according to clinical trial data, 90 percent of patients reported satisfaction through one year after treatment with Juvéderm® Volbella XC and said they would recommend the treatment to a friend. “The results of the clinical trial demonstrate significant improvements in the appearance of under eye hollows and overall appearance,” Dr. Woodward shares. “In addition, 80 percent of subjects reported they were a little or not at all bothered by how tired and old the under eye area looked at three months compared to 15 percent and 30 percent before treatment, respectively.”

Under Eye Filler Recovery & Results

The majority of patients in the clinical trials experienced side effects such as injection site tenderness, bruising, swelling, lumps and bumps, redness, pain after injection, firmness, discoloration (other than redness or swelling), and/or itching. This data is based on patient reporting in their 30-day daily diaries. Allergan Aesthetics notes that a majority of these side effects were “mild in severity” and “easily tolerated” – though some subjects experienced mild swelling that lingered for more than 30 days post-treatment. One patient in that group required treatment with antibiotics (the rest did not require intervention), and all of these effects resolved by day 45.

The results of all hyaluronic acid-based fillers are temporary, and under eye filler is no exception. Based on the clinical studies, patients reported being satisfied with their results from Juvéderm® Volbella XC for at least 12 months.