Icon Bioscience announced that the FDA has approved the company's new drug application for Dexycu (dexamethasone intraocular suspension), a dropless, long-acting therapeutic for treating inflammation associated with cataract surgery.
“Dexycu breaks new ground in the treatment of inflammation in post cataract surgery because it is applied as a single injection administered at the conclusion of surgery," David S. Tierney MD, Icon Bioscience's President & CEO, said in a company news release. "Dexycu employs Icon Bioscience’s Verisome technology to dispense a biodegradable extended-release formulation of dexamethasone into the posterior chamber of the eye.
Commenting on the 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.”
“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. Donnenfeld added.
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 options that challenge and surpass the traditional pharma approach to eye care. 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.”