July 16, 2014
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Ozurdex implant yields significant visual gain in pseudophakic patients with DME

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A steroid-eluting implant improved vision for 3 years in pseudophakic patients with diabetic macular edema, according to an expert.

In June, the U.S. Food and Drug Administration approved Ozurdex (dexamethasone intravitreal implant 0.7 mg, Allergan) for adults with DME who are pseudophakic or are phakic and scheduled for cataract surgery.

The sustained-release, biodegradable implant was previously approved for the treatment of macular edema following branch retinal vein occlusion or central retinal vein occlusion, as well as for the treatment of uveitis.

During a webinar sponsored by Allergan, Pravin U. Dugel, MD, and Scott M. Whitcup, MD, discussed results from the Macular Edema Assessment of Implantable Dexamethasone in Diabetes (MEAD) study, which supported the FDA’s approval of the implant for pseudophakic and phakic patients with DME.

Dugel served as clinical investigator in the MEAD study. Whitcup is executive vice president for research and development and chief scientific officer for Allergan.

The MEAD study comprised two 3-year, multicenter, sham-controlled, randomized clinical trials. The main outcome measure was the percentage of patients who gained 15 letters or more in best corrected visual acuity.

“It is very important to understand that at the time Allergan designed the MEAD study, there were no approved pharmacological treatments for DME. Sham, therefore, was used as a comparator,” Dugel said.

Visual gains were sustained for the entire study period among pseudophakic patients who received the implant, he said.

“Improvements in BCVA were maintained throughout the 3-year study period in those patients in the Ozurdex group who were pseudophakic at baseline,” Dugel said.

Among pseudophakic patients, mean gain in BCVA at 39 months was 5.8 letters in the Ozurdex group and 1.4 letters in the sham group, according to Dugel.

A higher percentage of phakic patients with DME treated with Ozurdex developed cataract or lens opacity, compared with phakic patients who underwent sham treatment, Dugel said.

Disclosure: Dugel is a consultant for Allergan.