Big News: There’s Now an FDA-Approved Filler for Under-Eye Hollows

For one of the most complained about aesthetic concerns, under-eye-hollows, it’s somewhat surprising we’ve not yet had an FDA-approval gain filler to correct the problem. That is, until now. Big news comes today from Allergan Aesthetics, parent company of the Juvéderm collection of hyaluronic acid fillers: Juvéderm Volbella, which has been used in the US since 2016 for lip enhancement, is now also indicated for the improvement of under-eye hollows in adults over the age of 21.

Though FDA-approval makes it “official,” Volbella has actually been used “off-label” under the eyes for years, as many doctors favor it for the area (also known as the tear trough) because it’s a thinner injectable. “The filler a doctor recommends for this area is important because many of them are too thick or cause too much swelling under the eyes,” says Bannockburn, IL dermatologist Heather Downes, MD.

According to clinical trial data, 90-percent of patients reported satisfaction through one year after their treatment with Volbella in their under-eye hollows, and were willing to recommend the treatment to a friend. Reported side effects were similar to that of other hyaluronic acid facial fillers, including tenderness to the touch, bruising, swelling, lumps/bumps, redness, pain after injection, firmness, discoloration (not redness or swelling) or itching, which typically resolves quickly after treatment.

“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 Durham, NC oculoplastic surgeon Julie Woodward, MD. “This is in part because it is a sensitive area to inject as it takes great skill and precision. The characteristics of Juvéderm Volbella with lower amounts of hyaluronic molecules and low water affinity provides a soft acid, smooth formulation appropriate for treating under-eye hollows. The results of the clinical trial demonstrate significant improvements in the appearance of under-eye hollows and overall appearance. 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.”

It’s important, however, to keep in mind that the tear troughs can be a very tricky area to “fill,” so make sure you’re getting safe injections and optimal results by choosing a board-certified dermatologist or plastic surgeon who is properly trained and very familiar with this part of the facial anatomy.

“Under-eye fillers are a great option for those who are hollow and with no visible fat prolapse,” says Beverly Hills, CA ocuplastic surgeon Christopher Zoumalan, MD. “Careful injections to the correct area without overfilling can often create beautiful results. As an oculoplastic surgeon who performs under-eye fillers and blepharoplasty surgery, it’s too often that I see patients referred to me who have had under eye filler-related issues, such as lumps, bumps, visible product, worsening fat pockets, stretched-out skin, and even swelling, when they are not performed correctly or they are performed on a patient who is not a candidate. Those who actually have under-eye fat prolapse and hollowing are better suited to undergo a lower eyelid blepharoplasty with fat repositioning, where both the prolapsed fat and under-eye hollowing are addressed at the same time. If you are considering under-eye fillers, but are concerned that you may actually be better served by having a lower eyelid blepharoplasty, you should meet with an expert surgeon that performs both procedures so that you have the best options presented to you.”

Per the FDA’s requirement for this new indication, Allergan Aesthetics is providing a product training program for all interested providers, which includes facial anatomy and considerations for safe injection in this area, as well as identification and management of potential complications. According to the company, successful completion of this training is necessary prior to administration of Volbella for this new indication.

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