WOBURN, MASS. Anika Therapeutics will soon launch its recently approved soft tissue filler, interimly named cosmetic tissue augmentation (CTA). The company is touting the filler as one that will compete in the burgeoning dermal filler market in terms of durability, reduced pain and extrusion force.
According to Ed Gaj, R.Ph., M.S., franchise director of aesthetics at Anika Therapeutics, Woburn, Mass., cosmetic surgeons will use a 30-gauge needle to extrude CTA.
"Some of the products on the market require a 27-gauge needle. If you use a smaller needle, the anticipation would be less pain upon injection. We have also added lidocaine to our product to facilitate pain reduction," Mr. Gaj tells Cosmetic Surgery Times .From a durability perspective, Mr. Gaj says that CTA's high concentration (28 mg per ml) of hyaluronic acid should make a difference in how long its effects are sustained. Competitor Restylane (Medicus Aesthetics) offers 20 mg per ml, he notes.
CTA was approved based on a 200-patient, multi-center U.S. trial using a split-face design. Study protocol employed the Lemperle Rating Scale (LRS), a zero-to-five measurement of the depth of the wrinkle after the fill.
Researchers, including plastic surgeons and dermatologists, injected one side of patients' nasolabial folds with CTA and the other side with a human collagen product. While Mr. Gaj says he cannot discuss specifics of the as-yet unpublished study, he relates that CTA emerged with superior results in patient and physician satisfaction.
"What I can say is that, compared to collagen, more patients had superior results with the CTA product compared to collagen at four months and six months, and that the P value was less than or equal to .0001, according to the masked evaluator assessment," Mr. Gaj explains.
The masked investigators were unaware of which nasolabial folds had been treated with CTA or collagen, and these investigators were different from the treating investigators who administered the treatments and touch ups.
While the company's data to support pain reduction with CTA is limited, Mr. Gaj says researchers conducted a small add-on study to the 200-subject trial, in which physicians used whatever anesthetic they would normally utilize for pain control in the injection of dermal fillers and injected about 90 patients with CTA only.
"We asked patients in all the categories of different types of anesthetics what their pain levels were and there was really no difference, so we feel that the product was having an impact. We will have to look at that more closely now that we have approval," he adds.
Researcher-reported side effects included swelling and bruising, lasting about seven days, as well as erythema and discoloration.
CTA is the only hyaluronic acid product on the market containing lidocaine. And while the benefit of its addition has yet to be proven in humans, Mr. Gaj postulates that, as a vasoconstrictor, lidocaine should help minimize bruising.
Earlier this year, Anika Therapeutics signed a global license with Galderma to rename and market the dermal filler.
"We are filing amendments [with the U.S. Food and Drug Administration] to further improve the product before it goes to market sometime in the middle of 2007," Mr. Gaj says.