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FDA Approves Dexycu

Icon Bioscience Receives FDA Approval for Dexycu (dexamethasone intraocular suspension) for Treating Inflammation Associated With Cataract Surgery

Newark, CA (February 12, 2018) – 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 the United States Food and Drug Administration (FDA) has approved IBI’s New Drug Application (NDA) for Dexycu (dexamethasone intraocular suspension), a dropless, long-acting therapeutic for treating inflammation associated with cataract surgery.

IBI noted that in the US alone, over four million cataract surgeries are performed annually and that current standard of care for inflammation associated with the surgery involves a relatively arduous process by which patients, in a largely elderly population, assume the post-surgical responsibility of self-administering medicated eye drops, several times daily over a period of weeks.

David S. Tierney MD, IBI’s President & CEO, said “Dexycu breaks new ground in the treatment of inflammation in post cataract surgery because it is applied as a single injection administration at the conclusion of surgery.” Dexycu employs IBI’s Verisome technology to dispense a biodegradable extended-release formulation of dexamethasone into the posterior chamber of the eye.

Commenting on today’s announcement, Eric D. Donnenfeld, MD, Clinical Professor of Ophthalmology, New York University, and Trustee, Dartmouth Medical School, and lead investigator for Dexycu clinical studies, said, “The approval of Dexycu represents a significant advancement in ophthalmic drug development as Dexycu is the first long-acting intracameral product approved by the FDA for treating inflammation following cataract surgery.”

Dr. Donnenfeld continued by saying, “Dexycu is designed to improve the management of inflammation post cataract surgery. This novel ophthalmic medication offers the cataract surgeon the option of a single administration of a corticosteroid at the site of action. This, in turn, benefits patients by eliminating non-compliance and dosing errors associated with the current practice of relying on the patient dispensing frequent drops following cataract surgery.”

Dr. Tierney said, “FDA approval of Dexycu marks a key milestone in Icon’s commitment to deliver innovative advances in ophthalmic specialty pharmaceuticals by providing treatment that challenge and surpass the traditional pharma approach to eye care.” He concluded saying, “As Icon steps across the threshold from R&D to an approved product, we look forward to announcing our plans to bring Dexycu into the marketplace.”

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.

Source: Icon Bioscience, Inc.

Posted: February 2018

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