NDA Accepted for Anti-Inflammatory Inj Post-Cataract Surgery
Icon Bioscience announced that the Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Dexycu (dexamethasone) for the treatment of inflammation associated with cataract surgery.
Dexycu utilizes the Company's Verisome technology that provides a sustained-release, biodegradable formulation of dexamethasone directly into the anterior chamber of the eye. Dexamethasone, an anti-inflammatory agent, is given as a single injection right after cataract surgery. The extended-release drug delivery technology includes various small molecules, proteins, and monoclonal antibodies to control drug release within the eye for up to a year.
Dexycu injection was developed to help compliance—especially among elderly patients—and avoid dosing errors associated with conventional treatments that depend on self-administered eye drops multiple times a day.
The FDA has set a Prescription Drug User Fee Act (PDUFA) of February 12, 2018.
For more information visit IconBioscience.com.