FDA approves revised indication for Allergan DME treatment

September 30, 2014

The FDA has approved Allergan’s dexamethasone intravitreal implant 0.7 mg (Ozurdex), a sustained-release biodegradable steroid implant, for the treatment of diabetic macular edema (DME).

Irvine, CA-The FDA has approved Allergan’s dexamethasone intravitreal implant 0.7 mg (Ozurdex), a sustained-release biodegradable steroid implant, for the treatment of diabetic macular edema (DME).

The implant was originally approved in June as a treatment for DME in adult patients who have an artificial lens implant (pseudophakic) or who are scheduled for cataract surgery (phakic). Based on ongoing review of clinical data demonstrating efficacy and safety, the FDA has now approved the implant for use in the general DME patient population.

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"Allergan is committed to developing innovative treatment options that address unmet patient needs, and retinal diseases such as DME are extremely difficult to manage," said Scott M. Whitcup, MD, executive vice president, research and development and chief scientific officer, Allergan. "We are pleased that the updated indication supports the use of (the implant) to help improve vision for more patients with DME."

The FDA approval of the implant is based on the MEAD (Macular Edema: Assessment of Implantable Dexamethasone in Diabetes) study where it has demonstrated long-term efficacy in the treatment of DME without the need for monthly injections. 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 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 also 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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