Dermatology and aesthetics company Sebacia (Duluth, GA) has received U.S. FDA approval for its laser-activatable Sebacia Microparticles for inflammatory acne treatment. The achievement follows the company's completion of its pivotal study, which clearly demonstrated clinical efficacy and safety of the light-absorbing gold microparticles.
Sebacia Microparticles selectively target the sebaceous (oil-producing) glands. In the U.S., the microparticles are indicated for use as an accessory to 1064 nm lasers to facilitate photothermal heating of sebaceous glands for the treatment of mild to moderate inflammatory acne vulgaris. In the EU, they are CE-marked and sold in select markets.
The U.S. FDA clearance of the microparticles is based on results from a U.S. pivotal, randomized, controlled, blinded trial evaluating 168 patients with mild to moderate acne using either the microparticles with laser or with laser alone. In this study, the microparticles treatment arm demonstrated a 53% median reduction in inflammatory lesion count (ILC), compared to 45% median reduction achieved by the laser treatment alone. The study achieved its primary endpoint of demonstrating non-inferiority at 12 weeks. It also achieved several secondary endpoints including 30.1% of patients treated with the microparticles achieving a clear or almost clear IGA score (Investigator's Global Assessment of acne severity)—a significant accomplishment for an FDA-cleared acne product. All reported adverse events, regardless of study treatment, were of mild to moderate intensity. There were no severe adverse events, nor were there any serious and/or unanticipated adverse events related to study treatment.
For more information, please visit www.sebacia.com.