Alphaeon Corporation announced that the US Food and Drug Administration (FDA) agreed to the protocol for its phase III clinical study of EVOSYAL, to treat glabellar lines. ALPHAEON acquired the exclusive US and certain international distribution rights to EVOSYAL, a Botulinum toxinType Aneuromodulator,as part of its acquisition of Evolus Inc.
In the last 12 months,ALPHAEON has submitted its investigational new drug application for EVOSYAL and completed enrollment in its phase II study. “We are looking forward to initiating this pivotal study in January with our cohort of experienced US investigators,” said Rui Avelar, MD, ALPHAEON chief medical officer.“The agreement with the FDA on our phase III pivotal study protocol marks another keymilestone on the execution of our neuromodulator development plan, “ said Chris Marmo, president of ALPHAEON Beauty. ALPHAEON began enrollment of its phase III study on January 14th, 2015.
ALPHAEON Corporation, a subsidiary of Strathspey Crown Holdings, LLC, is a lifestyle healthcare company committed to working with board-certified physicians to provide innovative products and services that promote patient wellness, beauty and performance.