Ozurdex (dexamethasone intravitreal implant)
Allergan has received approval from the FDA for Ozurdex (dexamethasone intravitreal implant) 0.7 mg as a treatment for diabetic macular edema (DME) in adult patients who are pseudophakic or who are scheduled for cataract surgery. Ozurdex is a sustained-release biodegradable steroid implant that has shown long-term efficacy without the need for monthly injections, according to a company news release.
The Ozurdex implant uses the company’s Novadur solid polymer delivery system – a biodegradable implant that releases medicine over an extended period of time – to suppress inflammation, according to Allergan.
The FDA approval of Ozurdex for this indication is based on the MEAD (Macular Edema: Assessment of Implantable Dexamethasone in Diabetes) study. MEAD includes two multicenter 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 IOP. An increase in mean IOP was seen with each treatment cycle, and the mean IOP generally returned to baseline between treatment cycles, according to Allergan.
“DME is a complicated disease to treat, Pravin Dugel, MD, Clinical Associate Professor of Ophthalmology, Keck School of Medicine at the University of Southern California, Managing Partner of Retinal Consultants of Arizona, and clinical investigator in the MEAD clinical trial, said in the news release. “OZzurdex provides long-term improvement of DME without the need for monthly injections, which helps these patients who are also managing the other conditions common with diabetes.”
The Ozurdex implant is already 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.