Many injectables are available internationally well before they hit US shores.
As the FDA does their due diligence, international experts provide a sneak peek of what is to come and share their experience with a crop of highly anticipated fillers.
“Hyaluronic acid is the gold standard for fillers, as we have shifted the paradigm from collagens. There are more than 80 companies that produce hyaluronic acid fillers worldwide,” says dermatologist Hassan Galadari, MD, an Assistant Professor of Dermatology at the United Arab Emirates University in Dubai.
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Among the HA lines available are the Teosyal RHA range. The majority of Teoxane’s RHA filler range received FDA approval late in 2017, but the products likely won’t be on the market for a few more months. “RHA 2, 3, and 4 have been approved and RHA 1, which is mainly used for fine lines, is in the process of being approved,” Dr. Galdari says. They have been available in Europe and the rest of the world since 2015.
“The range is unique in its rheological properties and its stretchability in areas of dynamism,” he adds.
Other hyaluronic acid fillers that are likely coming to the US soon include the remaining range of the Belotero line: Soft, Volume, and Intense. These are made by the German company, Merz Aesthetics. These fillers would join their FDA approved counterpart, Belotero Balance, which has been available in the US for some time now.
A Pen to Note
Teoxane also makes the Teosyal Pen, available outside the US. The pen features an ergonomic and lightweight design, intended to provide greater ease of injection and a smooth experience for the patient. The constant flow of the injection prevents peaks of pressure that may be painful for the patient, the company says. The Pen may be most valuable for the oral, perioral, and periorbital areas.
Newer fillers may come to the US market with ingredients other than HA, including one that contains chitosan. Human testing is set to start this summer. “The protein, which is derived from shellfish and crustaceans, has the ability to enhance collagen production,” Dr. Galadari explains. “Unlike other biostimulant fillers, it is not made up of inorganic microspheres. It has sustained results that last for nearly two years in animal models.”
Polycaprolactone (PCL) filler, marketed internationally as Ellanse (Sinclair Pharma), is not yet FDA approved. Dermatologist Nick Lowe, MD uses Ellanse as an alternative to Sculptra in his Harley Street practice in London. It is composed of 70 percent aqueous carboxymethylcellulose (CMC) gel-carrier and 30 percent synthetic polycaprolactone microspheres. “There’s an immediate filling effect followed by neocollagenesis,” he says. He adds 1cc 1% lidocaine and mixes before injecting.
“It may take one to two years before approval is granted pending the results of the clinical trials, [but] the filler has been available since 2009 in Europe,” Dr. Galadari says of Ellanse.
Macrolane, a body-contour filler that was manufactured by Q-Med and recently acquired by Galderma, has been available globally since 2008. It has been referred to as a “boob jab” in the lay press. “This is a body filler, but it can interfere with mammograms,” Dr. Galdari warns. The filler is no longer manufactured. However, Galderma has introduced other fillers, Refyne and Defyne to the US market as well as rebranded Perlane as Restylane Lyft. Other fillers made by Galderma that are seeking FDA approval include Kysse and Volyme.