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    Sustained-release corticosteroid implant improves, slows progression of diabetic retinopathy

    Sustained intraocular delivery of fluocinolone acetonide (FAc) using the FAc 0.19 mg intravitreal implant (Iluvien, Alimera Sciences) improves and slows progression of diabetic retinopathy (DR), according to findings of post-hoc analyses of data from the pivotal Fluocinolone Acetonide for Diabetic Macular Edema (FAME) trials.

    Courtesy of Alimera Sciences

    “DR leads to progressive retinal vascular damage and local ischemia, ultimately causing vision loss primarily through diabetic macular edema (DME) and proliferative diabetic retinopathy (PDR),” said Charles C. Wykoff, MD, FAME investigator and a retina specialist in private practice in Houston, TX. “Secondary analyses of the phase III trials leading to FDA-approval of ranibizumab (Lucentis, Genentech) and aflibercept (Eylea, Regeneron) also showed those anti-VEGF treatments can significantly blunt the progression of non-PDR to PDR.”

    Related: Future of DME resting on new mechanisms of action

    Dr. Wykoff pointed out that based on the findings from the phase III FAME trials, the FAc intravitreal implant provides a similar benefit, but it does so with a greatly reduced treatment burden for patients. In the FAME trials, patients received an average of 1.3 injections over a period of 3 years, whereas the anti-VEGF agents were administered monthly to bimonthly in the pivotal trials.”

    “In eyes with DR, there is an increase in leukocyte adhesion to retinal vascular endothelial cells that leads to endothelial cell damage, leukocytic plugging, and vessel closure, all of which contributes to progression of DR,” said Peter A. Campochiaro, MD, FAME investigator and professor, Johns Hopkins Wilmer Eye Institute, Baltimore, MD. “Reduction of leukocyte recruitment in diabetic eyes is the likely mechanism by which the FAc intravitreal implant slows DR progression, and sustained delivery of low levels of steroid in the eye are ideal for this indication.”

    More: Study tracks clinical use of dexamethasone implant for DME

    “The long-acting, slow-release, steady-state effects of the FAc intravitreal implant will have a substantial role to play as the focus in our field continues to shift from solely treating DME and PDR to managing the underlying pathophysiology of DR itself,” Dr. Wykoff added.

    FAME findings


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