IRVINE, CA, USA I January 22, 2015 I ALPHAEON® Corporation announced today that the U.S. 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 U.S. and certain international distribution rights to EVOSYAL, a Botulinum toxin Type A neuromodulator, 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 U.S. investigators,” said Rui Avelar, MD, ALPHAEON Chief Medical Officer.
“The agreement with the FDA on our phase III pivotal study protocol marks another key milestone on the execution of our neuromodulator development plan, ” said Chris Marmo, Ph.D. President of ALPHAEON Beauty.
ALPHAEON began enrollment of its phase III study on January 14th, 2015.
About ALPHAEON Corporation
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. For more information, please visit www.alphaeon.com.
About Strathspey Crown
Strathspey Crown is a leading firm focused in lifestyle healthcare. Strathspey Crown uniquely partners with board certified physician specialists to bring to market innovative technologies and services in the self-pay sector. The firm is founded with physician investors across key medical specialties including: plastic surgery, ophthalmology, dermatology, orthopedics and cosmetic dentistry. For more information, please visit www.strathspeycrown.com.
SOURCE: Alphaeon
Post Views: 27
IRVINE, CA, USA I January 22, 2015 I ALPHAEON® Corporation announced today that the U.S. 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 U.S. and certain international distribution rights to EVOSYAL, a Botulinum toxin Type A neuromodulator, 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 U.S. investigators,” said Rui Avelar, MD, ALPHAEON Chief Medical Officer.
“The agreement with the FDA on our phase III pivotal study protocol marks another key milestone on the execution of our neuromodulator development plan, ” said Chris Marmo, Ph.D. President of ALPHAEON Beauty.
ALPHAEON began enrollment of its phase III study on January 14th, 2015.
About ALPHAEON Corporation
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. For more information, please visit www.alphaeon.com.
About Strathspey Crown
Strathspey Crown is a leading firm focused in lifestyle healthcare. Strathspey Crown uniquely partners with board certified physician specialists to bring to market innovative technologies and services in the self-pay sector. The firm is founded with physician investors across key medical specialties including: plastic surgery, ophthalmology, dermatology, orthopedics and cosmetic dentistry. For more information, please visit www.strathspeycrown.com.
SOURCE: Alphaeon
Post Views: 27
