FDA Trials Approved

The U.S. Food and Drug Administration (FDA) has agreed to continued trials of potentially breakthrough skincare treaments. Alphaeon’s protocol for a Phase 3 clinical study of Evosyal, a botulinum toxin type A neuromodulator, began this month for the treatment glabellar lines. In the last 12 months, Alphaeon, a subsidiary of Strathspey Crown Holdings, submitted its investigational new drug application for Evosyal as well as completed enrollment in its Phase 2 study. Enrollment in the Phase 3 trial began on January 14, 2015. “We are looking forward to initiating this pivotal study in January with our cohort of experienced U.S. investigators,” said Rui Avelar, M.D., chief medical officer of Alphaeon. Botox and similar treatments used to treat wrinkles and more continue to rise.

Also, recently approved are Phase 2 trials of clinical research company Antria. The trials will focus on the of use autologous adipose-derived stem cells (ADSC) in plastic surgery. Antria’s patent-pending process does not include artificial dermal fillers or non-augmented fat grafts—they hope to create more natural-looking results by combining fat grafting with a patient’s own stem cells. The patient’s fat is removed via liposuction; stem cells are isolated and prepared from that material within an hour by using collagenase-based reagent Adipolyx; and the stem cells are injected into the patient’s face. “The medical benefits of Antria’s research on ADSCs are not limited to cosmetic surgery," says Leonard Maliver, M.D., CEO of Antria. "We believe we can apply our research on ADSCs to improve a wide range of medical conditions, including wound and fracture healing, congestive heart failure, and forms of arthritis." Antria will expand the Phase 2 clinical trial to include a much larger group of participants and will begin within the next 90 days in Gainesville, Florida.