Icon Bioscience announced that it has received notification from the 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,” David S. Tierney, MD, Icon’s President & CEO, said in a company news release. “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 postsurgery process of patients self-administering medicated eye-drops several times daily over a period of weeks.