The U.S. Food and Drug Administration (FDA) has agreed to ALPHAEON’s protocol for a Phase 3 clinical study of EVOSYAL, a botulinum toxin type A neuromodulator, 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 of 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, MD, chief medical officer of ALPHAEON.
