FDA Notifications
FDA approves treatment for facial fat loss
The FDA has approved injectable poly-L-lactic acid, an injectable filler to correct facial fat loss in HIV patients.
Injectable poly-L-lactic acid (Sculptra) is the first such treatment approved for a condition known as lipoatrophy, or facial wasting, a sinking of the cheek, eye, and temple areas of the face caused by the loss of fat tissue under the skin, which can affect HIV patients. The FDA expedited review of the product because of its importance in treating people living with AIDS.
The substance is a biodegradable, biocompatible synthetic polymer from the alphahydroxy-acid family that has been widely used for many years in dissolvable stitches, bone screws, and facial implants.
The FDA approval was based on data from four studies, totaling 277 HIV-positive patients with severe facial lipoatrophy. The patients, who were all being treated with antiretroviral drugs, were primarily white males, mostly ages 41 to 45. Patients were given three to six injections at two-week intervals and were followed for two years.
Skin thickness measurements and serial photographs from clinical studies were assessed, as well as other data submitted by the manufacturer, Dermik Laboratories.
Analysis indicated that the product significantly improved facial appearance, and was safe for restoration and/or correction of shape and contour deficiencies resulting from facial fat loss in patients with HIV/AIDS. The substance was shown to produce significant increases in dermal thickness (up to two to three times baseline values), adding volume to facial tissue and restoring shape to areas of the face with fat loss.
After an initial treatment series, repeat treatments may be needed to maintain the correction.
Most adverse events were related to the injection itself and included nodules, redness, swelling, and bruising in the injection area.
The studies also demonstrated significant improvement in quality of life and measures of anxiety and depression, conditions which can be associated with lipoatrophy.
The FDA has approved injectable poly-L-lactic acid, an injectable filler to correct facial fat loss in HIV patients.Subscribe Now for Access
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