FDA approves Ozurdex for diabetic macular edema

Food and Drug Administration (FDA) has approved Allergan's Ozurdex (dexamethasone 0.7 mg, a sustained-release biodegradable intravitreal implant), for the treatment of diabetic macular edema (DME). 

Ozurdex was earlier approved  as a treatment for DME in adult patients who have an artificial lens implant (pseudophakic) after cataract surgery, or those who are scheduled for cataract surgery. 

According to the U.S. Centers for Disease Control and Prevention, as of 2010, 25.8 million people — 8.3 percent of the U.S. population — have diabetes; 1.9 million new cases of diabetes were diagnosed in people aged 20 years or older in 2010. DME is a growing public health problem due to the increasing prevalence of diabetes, and is currently considered to impact 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 an innovative solid polymer biodegradable delivery system that releases medicine over an extended period of time - to suppress inflammation, which plays a key role in the development of DME.

The FDA approval is based on the MEAD (Macular Edema: Assessment of Implantable Dexamethasone in Diabetes) study where Ozurdex has demonstrated long-term efficacy in the treatment of DME without the need for monthly injections. MEAD includes two multi-center 3-year sham-controlled, masked, randomized clinical studies assessing the proportion of patients with 15 or more letters improvement in best-corrected visual acuity (BCVA) from baseline. The most common adverse events in the studies included cataracts and elevated intraocular pressure (IOP). An increase in mean IOP was seen with each treatment cycle, and the mean IOP generally returned to baseline between treatment cycles.

The Ozurdex implant is also indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) and for the treatment of non-infectious uveitis affecting the posterior segment of the eye.

The current FDA approved indications for Ozurdex 0.7mg implant are:

• 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.

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