Two-year PALADIN results show positive outcomes of Iluvien implant
Two-year interim outcomes of the PALADIN study showed that sustained, continuous release of fluocinolone acetonide through the Iluvien implant resulted in significant reduction of mean central subfoveal thickness in diabetic macular edema.
In addition, vision was improved or stabilized with one or fewer supplemental treatments per year in the majority of patients with persistent or recurrent DME, and the IOP profile was predictable and manageable.
“Chronic low-grade inflammation is an early and central process in the development of diabetic macular edema. Corticosteroids address multiple inflammatory cytokines and growth factors involved in this low-grade inflammatory response, and this attracts their use in this condition,” Victor H. Gonzalez, MD, said at the virtual Association for Research in Vision and Ophthalmology meeting.
PALADIN is an ongoing 3-year prospective phase 4 study based in the United States. Interim analysis included 115 eyes of 95 patients with DME who completed the 24-month visit after Iluvien (Alimera Sciences) implantation.
“An amendment to the protocol allowed us to collect up to 36 months of retrospective data prior to fluocinolone implantation. In the 36 months prior to enrollment, there was a progressive decrease of 8 to 10 letters due to significant undertreatment. Post-implantation, patients stabilized or gained up to 3 letters of vision. More than 50% required less than one additional treatment in the 2 years, and 44% received no additional treatment in 24 months,” Gonzalez said.
An organized, progressive decrease in central subfoveal thickness toward a more normal anatomy was seen as a result of the treatment.
The IOP profile was predictable and manageable, he said. Mean IOP did not show significant variation, and in the majority of patients who had an IOP event, this was controlled with IOP-lowering medications.
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Gonzalez VH. Two year outcomes from the PALADIN phase 4 study: anatomic/functional changes and reduced treatment frequency associated with the 0.19 mg fluocinolone acetonide implant (FAc) in patients with persistent or recurrent diabetic macular edema. Presented at: Association for Research in Vision and Ophthalmology annual meeting; June 12, 2020 (virtual meeting).
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