Compared with all that are available worldwide, fillers in the United States comprise a fairly limited selection, says Hassan Galadari, M.D., assistant professor of dermatology at the United Arab Emirates University, Al Ain.
Boston - Compared with all that are available worldwide, fillers in the United States comprise a fairly limited selection, says Hassan Galadari, M.D., assistant professor of dermatology at the United Arab Emirates University, Al Ain.
In response to the limited number of indications available in the United States, he says, "Many of my American colleagues end up diluting HA (hyaluronic acid) with lidocaine or saline so that they can inject in sensitive areas such as underneath the eye or in the crows' feet.”
Dr. Galadari discussed the current state of fillers, both internationally and in the United States, at the 2012 American Academy of Dermatology Summer Academy Meeting.
Internationally, the Restylane (HA, Medicis) line includes half a dozen options, each with its own indication, Dr. Galadari says. However, only two versions - Restylane and Perlane (Medicis) - have Food and Drug Administration approval.
Dr. Galadari says Juvéderm’s (HA, Allergan) offerings are similarly limited stateside, although he predicts that Juvéderm Voluma, which has been approved in Canada for years, will be approved in the United States by the end of 2012.
One product in the Restylane family that's not available in the United States is Restylane Vitale, a cross-linked but less concentrated form of HA that's injected in the superficial dermis for plumping purposes, Dr. Galadari says.
"It doesn't add much volume," Dr. Galadari says; rather, it draws water, improving skin hydration in areas such as the neck, décolletage, hands and face. Injected as directed (up to three sessions at two-week intervals), Vitale produces results that last about six months. "It's been very popular in Europe and the Middle East,” he says.
Teosyal (HA, Teoxane) has wrapped up clinical trials in the United States and has been submitted for FDA approval. "I hope it will be approved, if not by the end of this year, then definitely by the beginning of 2013," Dr. Galadari says.
Teosyal, which contains eight products in its line, is the third most popular filler worldwide, according to Dr. Galadari. "Once it's FDA-approved, it's probably going to be the top filler in worldwide sales,” he says.
Undergoing trials internationally is Ellansé (polycaprolactone, Aqtis Medical). "Polycaprolactone is found in many substances, including absorbable suture material, amongst other things, so it's very safe," Dr. Galadari says.
In addition to short-term effects, "Ellansé provides a sustained benefit that lasts one to one-and-a-half years, in its short-lasting form, Ellansé-S,” he adds. “The longest duration is achieved by Ellansé-E, which can last about four years. The results are both much more durable and reliable than those of Radiesse (calcium hydroxylapatite, Merz) for larger-volume facial contouring."
Preliminary six-month results of an ongoing 12-month trial show that Ellansé has significantly outperformed Perlane from the three-month mark, says Dr. Galadari, a study investigator.
Aqtis is looking to conduct clinical trials in the United States, according to Dr. Galadari. "If all goes as planned, Ellansé will gain FDA approval by the end of 2014."
Disclosures: Dr. Galadari has received honoraria from Allergan, Galderma/Q-Med, Merz, Teoxane and Aqtis (which also provided clinical trial support) but reports no relevant financial interests.
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