Icon Bioscience said today that the FDA accepted the company’s submitted new drug application for its Dexycu drug designed to be used as an anti-inflammatory following cataract surgery.
The Newark, Calif.-based company’s Dexycu utilizes the company’s Verisome novel drug delivery system designed to treat ophthalmic diseases and slowly release the drug while the Verisome system simultaneously degrades, according to the company’s site.
Dexycu uses Verisome to deliver a sustained-release, biodegradable formulation of the anti-inflammatory dexamethasone directly into the anterior chambero f hte eye through a single injection, Icon Biosciences said.
The company said that the FDA gave it a user fee goal date of Feb. 12, 2018.
“This is an important landmark event in advancing Dexycu through the regulatory process into the marketplace. We look forward to working with the FDA during this review process to obtain marketing approval,” prez & CEO Dr. David Tierney said in a prepared statement.
