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The three-year, phase IV, real-world observational PALADIN study evaluated the long-term safety of ILUVIEN for patients with DME. This study data supports the benefit of using a prior course of corticosteroid to mitigate the risk of uncontrolled IOP elevations. The study also reported secondary outcomes of vision improvement and reduction in treatment burden and retinal thickness variability.
There were a total of 202 eyes of 159 patients enrolled in the study. The mean follow-up length for these eyes was 27.6 months and 94 eyes completed 36 months of follow-up.
The 94 eyes that completed 36 months experienced a mean 3.6 letter increase in BCVA. Prior to ILUVIEN, eyes experienced a mean change of -8.4 letters despite most patients having received prior DME treatment. *
IOP increases that occurred were considered manageable with standard treatments.
IOP increases of > 30 mmHg occurred in 10.9% of eyes.
20% of eyes required IOP-lowering medication.
2.97% of eyes required IOP-lowering surgery, half of which were due to neovascular glaucoma. This compares favorably to the 4.8% seen in the pivotal FAME Studies.
IOP response 25 mmHg after the steroid challenge predicted a similar outcome after ILUVIEN treatment at the final visit in 97% of eyes.