FDA approves Allergan implant for DME treatment

Irvine, CA-The FDA has approved Allergan’s dexamethasone intravitreal implant (Ozurdex), as a treatment option for diabetic macular edema (DME) in adult patients who have an artificial lens implant or who are scheduled for cataract surgery.

According to Allergan, the sustained-release biodegradable steroid implant uses the proprietary Novadur solid polymer delivery system-a biodegradable implant that releases medicine over an extended period-to suppress inflammation, which plays a key role in DME development.

“DME is a common cause of vision loss in patients with diabetes,” said Scott M. Whitcup, MD, executive vice president, research and development, and chief scientific officer, Allergan. “(The implant) exemplifies our continued commitment to the development of innovative therapies for difficult-to-treat retinal diseases and offers a new treatment option to improve vision for certain patients with DME.”

The FDA’s approval of the implant for this indication is based on the Macular Edema: Assessment of Implantable Dexamethasone in Diabetes (MEAD) study.

MEAD included 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 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.

The implant is already indicated for the treatment of macular edema following branch retinal vein occlusion or central retinal vein occlusion, and for the treatment of non-infectious uveitis affecting the posterior segment of the eye.

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