NEWARK, Calif.--(BUSINESS WIRE)--Icon Bioscience Inc. (IBI), a specialty biopharmaceutical company focused on utilizing its Verisome® drug-delivery platform to develop unique intraocular eye-care therapeutics, today announced that it has received notification from the U.S. Food and Drug Administration (FDA) that the agency has accepted for filing the Company’s recently submitted new drug application (NDA) for DEXYCU® (IBI-10090).
In accordance with the FDA's standard review designation, the agency has established a user fee goal date under the Prescription Drug User Fee Act (PDUFA) of February 12, 2018.
Such notification indicates that FDA has determined that the NDA for DEXYCU is sufficiently complete to permit a substantive review by the agency, and the PDUFA action date targets the potential approval of DEXYCU in early 2018.
“This is an important landmark event in advancing DEXYCU through the regulatory process into the marketplace,” said David S. Tierney, MD, Icon’s President & CEO. “We look forward to working with the FDA during this review process to obtain marketing approval.”
DEXYCU employs Icon’s Verisome® technology to dispense a sustained-release, biodegradable formulation of the anti-inflammatory agent dexamethasone directly into the anterior chamber of the eye through a single injection administered by the physician immediately following cataract surgery. DEXYCU has been developed to help patients, in a largely elderly population, avoid noncompliance and dosing errors associated with the current standard-of-care which relies on a burdensome post-surgery process of patients self-administering medicated eye-drops several times daily over a period of weeks.
About Icon Bioscience and Verisome®
Icon Bioscience, Inc. is a privately held specialty biopharmaceutical company focused on the development and commercialization of unique ophthalmic pharmaceuticals based on its patented and proprietary Verisome® extended-release drug delivery technology. The technology encompasses a broad number of related but distinct drug delivery systems capable of incorporating an extensive range of active agents, including small molecules, proteins and monoclonal antibodies. Moreover, this drug delivery platform is a highly advanced, yet elegantly formulated system for controlling the release of medication within the eye for up to a year through the administration of a single injection. The technology’s exceptional versatility can support products individually formulated to meet the particular clinical requirements of a given active agent targeting a specific ophthalmic disease. For additional information visit the Icon website at www.iconbioscience.com.