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FDA accepts Alphaeon's IND application for Evosyal

The Alphaeon Corporation announced that the U.S. Food and Drug Administration has accepted the company’s Investigational New Drug application to conduct clinical studies for Evosyal, an advanced botulinum toxin Type A neurotoxin.

The neurotoxin was acquired by Alphaeon in October 2013, as part of the acquisition of Evolus.

Alphaeon expects the initial clinical trial to be fully enrolled by the end of 2014, according to a company press release.

“Evosyal represents the state-of-the-art in both consistent manufacturability and potency as a 900 kDa neurotoxin molecular complex with a high purity, both of which we believe will aid in achieving precise, predictable and long-lasting patient outcomes,” John Gross, MD, chief scientific officer for Evolus, said in the press release.