Science of DME Newsfeed Archived News
FDA approves biodegradable dexamethasone intravitreal implant for the treatment of diabetic macular edema
The U.S. Food and Drug Administration (FDA) has approved dexamethasone intravitreal implant (OZURDEX®) at a dose of 0.7 mg for treating diabetic macular edema (DME) in adult patients who have an artificial lens implant (pseudophakic) or who are scheduled for cataract surgery (phakic). OZURDEX® is a sustained-release biodegradable steroid implant that demonstrated long-term efficacy without the need for monthly injections. It is a prescription medicine that is an implant injected into the eye (vitreous).
DME currently impacts more than 560,000 Americans. It is an eye condition that can occur in people with diabetes (types 1 and 2) and causes fluid to leak into the part of the eye where focusing occurs (macula), causing blurred vision, vision loss and eventual blindness. The OZURDEX® implant uses the proprietary NOVADUR® solid polymer delivery system – a biodegradable implant that releases medicine over an extended period of time – to suppress inflammation, which plays a key role in the development of DME.
OZURDEX® is also used:
To treat adults with swelling of the macula (macular edema) following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
To treat adults with non-infectious inflammation of the uvea (uveitis) affecting the back segment of the eye
To treat adults with diabetic macular edema who have an artificial lens implant (pseudophakic) or who are scheduled for cataract surgery (phakic).