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New hyaluronic acid fillers boost cosmetic treatment options
New fillers, including even more hyaluronic acid (HA) fillers, as well as new toxins are expected to enter the U.S. market within the next year, according to William Philip Werschler, M.D., F.A.A.D., assistant professor of clinical medicine and dermatology, University of Washington School of Medicine, Seattle.
New hyaluronic acid fillers boost cosmetic treatment options

More fillers, toxins on market means increased competition, lower prices
Technology advancements allow for improved levels of tissue integration
Thinner, lighter hyaluronic acid fillers hitting the market
Seattle New fillers, including even more hyaluronic acid (HA) fillers, as well as new toxins are expected to enter the U.S. market within the next year, according to William Philip Werschler, M.D., F.A.A.D., assistant professor of clinical medicine and dermatology, University of Washington School of Medicine, Seattle.

"Consumers will have more choices, and physicians will have more choices," says Dr. Werschler, who also has a private practice in Spokane, Wash. "It will likely lower the prices for consumers and force more competition, especially among the hyaluronic acid manufacturers.

"The more products that are available, the better for everyone," Dr. Werschler says. "There will be nice additions to the palette of fillers that are already available (in the United States)."

Belotero, launched by Merz in the United Kingdom in 2007, is a hyaluronic acid filler available in three concentrations: soft, basic and intense.

"It has been filed with the Food and Drug Administration (FDA), and it is anticipated it will be available later this year in the U.S.," Dr. Werschler says. "It is a hyaluronic acid that is very similar to Juvderm (Allergan)."

Technology advances

There are significant improvements in the technology that provide for an improved level of tissue integration, however. Essentially, Belotero uses a production process called "cohesive polydensified matrix (CPM)."

The CPM process gives the product the ability to "auto-equalize" itself in the soft tissues into which it is injected. "This reduces the lumps and bumps that can sometimes occur with HA injections, and even further reduces the need for the use of hyaluronidase," Dr. Werschler says.

The shortcoming with Belotero is that lidocaine is not part of the formulation, as it is with some hyaluronic acid fillers, such as Juvderm XC and Restylane L and Perlane L (HA, lidocaine; Medicis). The presence of lidocaine in those fillers increases patient comfort, Dr. Werschler says.

"There will initially be a market disadvantage, but mixing of lidocaine at the time of injection as has been commonly been done in the past will still be an option, although this will be off-label until FDA-approved," he says.

Another hyaluronic acid filler that Dr. Werschler describes as part of the Restylane family is SubQ, made from a nonanimal stabilized hyaluronic acid substance (NASHA). It is not approved for use in the United States. SubQ has been used for breast and buttock augmentation, offering noninvasive avenues for cosmetic procedures for those sites.

"It is pretty popular for techniques like breast augmentation, and it has a duration of about one year," Dr. Werschler says. Patients undergo an injection termed a "breast-bump" of about 100 ccs into each breast with SubQ. This results in about one cup size expansion. Celebrities have been reported to have undergone injections with SubQ. "There are rumors that Medicis will try and bring it into the (U.S.) market," Dr. Werschler says.
Weighty options

Similarly, Voluma, a member of the Juvderm family that has similar features as SubQ, is being prepared for introduction in the United States. These products represent an expansion of the heavier, or thicker, HA product lines.

At the other end of the spectrum are products that are thinner and lighter than HAs currently available. Restylane Vital and a similar product from Allergan, Juvderm Hydrate, are designed to be placed very superficially into the skin in a way that approaches mesotherapy.

"Restylane Vital even has a specialized auto-injection pen that winds up like a spring and then releases controlled amounts with each pull of the trigger," Dr. Werschler says.

A pure collagen stimulator, similar to Sculptra Aesthetic (poly-L-lactic acid, Sanofi-Aventis), is working its way into the U.S. market, according to Dr. Werschler. It has been marketed as Derma Veil (Medinter Ltd.) outside the United States, and it uses polylactic and polyglycolic acids (PLGA) to achieve a collagen-stimulating effect.

Novabel, another Merz product, is a unique injectable with a biocompatible alginate composition, derived from brown sea algae. The composition of Novabel, which is currently available in Europe, reportedly makes injection easier and results in less swelling. Clinical trials will soon begin in the United States, Dr. Werschler says.

The formulation of Novabel, which uses the company's patented Geleon technology, reportedly creates greater elasticity when the filler is used as a facial shaping agent. It injects easily and can be used in thin-skinned areas such as the eyelids and tear troughs.

Complex toxin competition

Two new botulinum toxin type A products are poised to enter the U.S. market that may offer a theoretical advantage over Botox (onabotulinumtoxinA, Allergan) and Dysport (abobotulinumtoxinA, Medicis). Botox and Dysport are complex toxins, meaning they have the active protein structure complexed to other, inactive proteins. Merz's NT201 or Xeomin is not yet available in the United States, nor is Mentor's PurTox, or purified botulinum type A neurotoxin.

"These are both naked toxins," Dr. Werschler says. "Theoretically, patients would have less protein exposure and have less risk of allergic reaction or the development of blocking antibodies. In some therapeutic areas, you can use higher doses (of these toxins) without worrying about the risk of protein exposure. The naked toxins theoretically could last longer and work faster. The jury is out, however, with regard to real-life advantages for the aesthetic patient."

Disclosures: Dr. Werschler reports financial relationships with the manufacturers of all products mentioned in this article.

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