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Improvement seen with low-dose corticosteroid treatment for severe, chronic DME

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LAS VEGAS — There is a subgroup of patients with chronic diabetic macular edema who appear to be relatively resistant to treatment with anti-VEGF monotherapy and who might benefit from therapy with corticosteroids, a speaker said.

“DME is a multifactorial disease. … There is good scientific basis for classifying DME as chronic and not chronic,” Pravin U. Dugel, MD, told colleagues at the American Society of Retina Specialists meeting here.

Pravin U. Dugel

Citing a pre-planned subgroup analysis of patients enrolled in the low-dose arm of the FAME parallel studies, Dugel said that patients with severe, chronic DME did significantly better with the Iluvien implant (fluocinolone acetonide, Alimera Sciences). In FAME A and B, patients were randomized to three treatment groups: a high-dose 0.5-µg group, a low-dose 0.2-µg group or a control group.

“Both FAME studies were consistent in confirming the role for a slow-release corticosteroid device for patients with chronic DME,” Dugel said.

Regarding safety data for both the high- and low-dose groups, Dugel said that the risk for endophthalmitis was low at 0.2%, but the risk for IOP-related events and the need for cataract extraction were higher, with 50.1% of the entire patient population needing cataract extraction.

“The inflammatory component is important in chronic DME; therefore, anti-VEGF drugs may be more effective in non-chronic DME, whereas corticosteroids may be more effective in chronic DME,” Dugel said.

The implant is currently approved in Europe for the indication of “vision impairment associated with chronic diabetic macular edema, considered insufficiently responsive to available therapies,” Dugel said.

“At the end of the day when this implant becomes available, it will not be a first-line agent in my office, but it will fill a very important unmet need in the treatment of patients with chronic, severe diabetic macular edema,” Dugel said.

•  Disclosure: Dugel is a consultant for Alimera Sciences.