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news.Icon Bioscience has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its lead pipeline product Dexycu (IBI-10090).
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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.
Eric D. Donnenfeld, MD, Clinical Professor of Ophthalmology, New York University, and Trustee, Dartmouth Medical School, and lead investigator for Dexycu clinical studies said: “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.
“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.”