Food and Drug Administration - December 29, 2006
Richard Klein

On December 22, 2006, the Food and Drug Administration approved Radiesse, an injectable (under the skin) implant to restore or correct signs of facial lipidatrophy, or fat loss, in people with human immunodeficiency virus (HIV). Radiesse, a sterile, semi-solid cohesive implant consisting of synthetic calcium hydroxylapatite suspended in a gel carrier, is a medical device. It is already approved for use as a tissue marker, for treatment of vocal fold insufficiency, and to correct certain dental defects.

The safety and effectiveness of RADIESSE for the treatment of facial lipoatrophy was evaluated in a prospective, open-label, multi-center study of 100 patients with human immunodeficiency virus and facial lipoatrophy. Study subjects were at least 18 years of age, HIV positive, with a CD4 count ≥ 250 /mm³ and viral load ≤ 5000 copies/mL, had been receiving HAART therapy for a minimum of 3 years, and had HIV-associated facial lipoatrophy that was a grade 2, 3, or 4 on the Facial Lipoatrophy Severity Scale. The study population consisted predominantly of multi-ethnic, non-smoking males (94% male) with a mean age of 48 years. Forty-four (44) percent of patients were Black, Hispanic or Asian. Fifty-six (56) percent were Caucasian.

Patients received an initial treatment (initial injection and an additional injection at 1 month as needed). Six months later, all patients were assessed for the need for a touch up injection. Effectiveness was assessed at 3, 6 and 12 months from initial treatment by means of a Global Aesthetic Improvement Scale (GAIS) rating, cheek skin thickness measurements, and patient satisfaction assessment. Safety was assessed by the recording of adverse events through 12 months.

All treatments were performed with a 25 gauge, 1½ inch needle. Mean initial treatment volumes were 4.8mL for the initial treatment and 1.8mL at 1 month if necessary (85% of patients were treated at 1 month). At 6 months, the mean touch up volume was 2.4mL (89% of patients). Four (4) percent of patients received only one treatment, 18% of patients received a total of two treatments and 78% of patients received a total of three treatments. No patient received more than three treatments.

Mean left cheek thickness measurements at baseline was 4.7mm (N=100). At 3 months, the mean thickness was 7.3mm (N=100), representing an increase of 2.6 mm from baseline, with p-Value = 0.0001. At 6 months the mean thickness was 7.1mm (N=97), representing an increase of 2.4 mm from baseline, with a p-Value = 0.0001.

Mean cheek thickness at baseline for the right cheek was 4.9 mm (N=100). At 3 months, the mean thickness was 8.0 mm (N=100), representing an increase of 2.1 mm from baseline, with a p-Value of 0.0001. At 6 months the mean thickness was 7.5 mm (N=97), representing an increase of 2.7 mm from baseline, with a p-Value of 0.0001.

The most common adverse events reported were temporary edema (swelling), ecchymosis (bruising), erythema (reddening) and/or pain at the injection site.

The calcium hydroxylapatite (CaHA) particles in Radiesse can be seen in X-rays and CT Scans. It is important that patients inform their doctor and other health care professionals that they have had Radiesse injected in the face. In a radiographic study of 58 patients, there was no indication that RADIESSE potentially masked abnormal tissues or was interpreted as tumors in CT Scans.

Radiesse is a product of BioForm Medical Inc., of Franksville, WI.

Richard Klein | HIV/AIDS Program Director | Food and Drug Administration
061229
FD061205

SOURCE: Food and Drug Administration (FDA).

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