Icon Bioscience reported the FDA approved its new drug application for Dexycu, a dropless therapeutic designed to treat inflammation associated with cataract surgery.
The current standard treatment after cataract surgery is self-administered medicated eye drops, several times a day over several weeks. The Dexycu (dexamethasone intraocular suspension) treatment is applied as a single injection at the end of surgery, David S. Tierney, MD, president and CEO of Icon Bioscience, said in a press release.
The treatment uses Icon’s Verisome drug delivery technology to dispense a biodegradable extended-release formulation of dexamethasone into the posterior chamber of the eye, according to the release.
“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 noncompliance and dosing errors associated with the current practice of relying on the patient dispensing frequent drops following cataract surgery,” Eric D. Donnenfeld, MD, lead investigator for Dexycu clinical studies, said in the release.