Icon Bioscience Submits NDA For DEXYCU, A Potential Transformational Drug Therapy For Treating Inflammation Associated With Cataract Surgery

SUNNYVALE, 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 the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for the Company’s lead pipeline product DEXYCU® (IBI-10090).

Supported by data from five clinical studies involving 660 patients, IBI is seeking FDA marketing approval of DEXYCU as a long-acting dropless treatment for inflammation associated with cataract surgery, a common post-operative occurrence that can lead to serious complications, if left untreated. About 4 million cataract surgeries are performed in the United States annually.

DEXYCU employs IBI’s Verisome technology to dispense a biodegradable extended-release formulation of the anti-inflammatory agent dexamethasone into the anterior chamber of the eye. It is applied through a single injection administration at the conclusion of cataract surgery. In comparison, the current standard-of-care involves a comparatively arduous process by which patients, in a largely elderly population, assume a post-surgery responsibility of self-administering medicated eye drops, topically, four times a day over a period of weeks.

“DEXYCU has been designed to improve the management of post-surgery inflammation by offering the physician the option of a single administration of the sustained-released anti-inflammatory agent at the site of action,” noted Eric D. Donnenfeld, MD, Clinical Professor of Ophthalmology, New York University, and Trustee, Dartmouth Medical School, and lead investigator for DEXYCU clinical studies. “This, in turn, would benefit patients by eliminating noncompliance and dosing errors associate with the current practice of relying on the patient dispensing frequent corticosteroid drops in post cataract surgical care,” said Dr. Donnenfeld.

Commenting on today’s announcement, David S. Tierney, MD, Icon’s President and CEO, said “DEXYCU represents an opportunity for Icon to target what we consider to be a significant medical need in a major ophthalmic market.” He concluded saying, “Marketing approval of DEXYCU would not only provide an important new alternative therapy in post cataract surgical care, but would also significantly validate the commercial prospects of our Verisome drug-delivery platform, including Icon’s robust development pipeline of Verisome-based product potentials.”

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.