Overcoming HIV

FDA Approves Radiesse for Facial Lipoatrophy

In late December, the U.S. Food and Drug Administration (FDA) approved Radiesse, a new injectable therapy for the treatment of facial fat loss (lipoatrophy) in people with HIV; Radiesse was also approved as a cosmetic treatment for moderate-to-severe facial wrinkles and folds.

Radiesse, manufactured by BioForm Medical, contains a synthetic material that stimulates collagen production. Another product, Sculptra (poly-L-acetic acid), is also approved for treating lipoatrophy in HIV positive people.

Radiesse is not a permanent treatment, but is expected to last at least several months, and possibly as long as a few years.

Following is the letter from the FDA announcing the approval:

Radiesse Approved for Facial Lipoatrophy by FDA

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 [lipoatrophy], 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 cells/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 percent (44%) of patients were Black, Hispanic or Asian. Fifty-six percent (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, 1 and one-half inch needle. Mean initial treatment volumes were 4.8 mL for the initial treatment and 1.8 mL at 1 month if necessary (85% of patients were treated at 1 month). At 6 months, the mean touch up volume was 2.4 mL (89% of patients). Four percent (4%) 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 4.7 mm (N=100). At 3 months, the mean thickness was 7.3 mm (N=100), representing an increase of 2.6 mm from baseline, with P-Value = 0.0001. At 6 months the mean thickness was 7.1 mm (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.

01/05/07

Sources

Food and Drug Administration. Radiesse Approved for Facial Lipoatrophy by FDA. Announcement.

Bioform, Inc. BioForm Announces FDA Approval of Radiesse Facial Filler For Two New Aesthetic Applications. Press Release. December 27, 2006.

www.radiesse.com