Icon Bioscience said today that the FDA has approved its application for Dexycu, a long-acting therapy designed to treat inflammation in patients who have had cataract surgery.
More than four million cataract surgeries are performed each year in the U.S., according to the privately-held biopharma company, and most patients treat inflammation in their eyes using medicated eye drops over the course of several weeks.
Icon’s intraocular suspension uses the company’s Verisome extended-release drug delivery technology to dispense a long-acting formulation of dexamethasone into the posterior chamber of the patient’s eye.
“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,” president & CEO Dr. David Tierney said in prepared remarks.
“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. Eric Donnenfeld, lead investigator for Icon’s Dexycu clinical trials, added.
“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.”