Artes Medical Inc, a medical technology company focused on developing, manufacturing, and commercializing aesthetic injectable products for men and women, has submitted the results of a 5-year efficacy and safety study of ArteFill® to the FDA to enhance its product labeling.
ArteFill, which was approved by the FDA in October 2006, is the first and only nonabsorbable injectable filler for the correction of wrinkles known as smile lines or nasolabial folds. The microspheres in ArteFill provide long-lasting wrinkle correction in one or two treatments.
The study was based on data from the company’s 12-month controlled and randomized clinical trial, which compared outcomes for patients treated with ArteFill to those of patients treated with bovine collagen-based filler. At the 6-month evaluation—the primary evaluation period for the clinical trial—the wrinkle correction in patients treated with ArteFill persisted and showed improvement compared to the wrinkle correction in patients treated with the collagen control, who returned to their pretreatment status. ArteFill patients were also evaluated 1 year after treatment, demonstrating continued safety and wrinkle correction.
The follow-up study of 145 patients who were treated with ArteFill demonstrated its safety and showed improvement in patient wrinkle correction 5 years after the patient’s last ArteFill treatment. It also showed improvement in wrinkle correction at the 5-year point compared to the 6-month evaluation period.
As part of the study, physician investigators and patients were asked to provide their assessment of an ArteFill treatment. More than 90% of the physician assessments were “completely successful” or “very successful” and more than 90% of the patient assessments were “very satisfied” or “satisfied.”
[Artes Medical Inc, March 21, 2007]