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Subspecialties Retina

From FAME to the Real World

When it comes to newly approved treatments, real-world evidence is always eagerly anticipated: how safe and effective is it really, outside the confines of the highly-controlled world of clinical trials? Iluvien (fluocinolone acetonide intravitreal implant) has been available in the European market since 2013 “for the treatment of vision impairment associated with the chronic diabetic macular edema (DME), considered insufficiently responsive to available therapies” – and an interim analysis of the Iluvien Registry Safety Study (IRISS), has recently been published (1). Iluvien elutes therapeutic drug concentrations for up to three years – and poor patient regimen compliance in the real world is something that often stops outcomes in clinical practice matching those in clinical trials. So can the IRISS results match those of the chronic DME population in its Phase III trial, FAME?

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