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FDA Approves Radiesse

The U.S. Food and Drug Administration (FDA) has approved Radiesse, a cosmetic dermal filler, for the long-lasting correction of moderate to severe facial wrinkles and folds such as nasolabial folds.

Radiesse is composed of calcium hydroxylapatite microspheres in a water-based gel carrier. The product provides immediate improvement so a patient looks better the moment the product is injected. The calcium microsphere technology also enables the body to generate new collagen. Further, Radiesse provides physicians a high level of control, predictability and finesse for facial applications.

FDA approval of Radiesse for treatment of facial wrinkles and folds was based on the results of a clinical trial supporting Radiesse’s safety and effectiveness. In this study, conducted at four medical centers in the United States, 117 patients with nasolabial folds were treated with Radiesse on one side of the face and a control agent (Cosmoplast, a human collagen product) on the other. Results based on the ratings of three blinded evaluators showed that six months after treatment, Radiesse was more effective than the control on every comparative efficacy outcome (p<0.0001).

Key clinical findings include:

· 82 percent of nasolabial folds treated with Radiesse showed improvement after six months. This was significantly higher than the control, which showed improvement in only 27 percent of treated folds (p<0.0001).

· After six months, the fold treated with Radiesse was more improved in 79 percent of patients compared to the control-treated fold. The folds treated with the control rated more improved in only 5 percent of patients.

· The nasolabial folds treated with Radiesse required approximately half as much volume (1.22cc) than the folds treated with the control (2.35cc).

· Both products were safe and well tolerated, with no serious adverse events reported. In the 117 patients treated, Radiesse had zero granulomas and the same low rate of nodules as the control.

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