PALADIN Phase IV Study confirms safety of Iluvien in diabetic macular oedema

The three-year, phase IV, real-world observational PALADIN study evaluated the long-term safety of Iluvien for patients with DME. This study confirms 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. The results were presented for two of the abstracts at the annual ASRS conference held in New York, NY.

Amongst the exploratory findings presented in these abstracts were: Eyes were under treated with 3.5 mean yearly treatments during the three years prior to the administration of Iluvien and lost on average 6.4 ETDRS letters during that time. Following the administration of Iluvien, eyes gained 4.5 ETDRS letters on average and treatment frequency was reduced to 1.7 mean yearly treatments. Significantly more eyes were able to achieve a dry retina (central subfield thickness (CST) at most 300 µm) following FAc administration when compared to baseline. Eyes experienced significantly less retinal thickness variability post-FAc treatment compared to baseline, as measured by retinal thickness amplitude (RTA) and standard deviation (RTSD). Reduced retinal thickness variability was shown to correlate with improved visual outcomes and better disease control. Eyes were able to maintain or improve their vision after receiving the 0.19 mg FAc implant regardless of their baseline visual acuity. Eyes with a baseline BCVA at least 20/40 maintained their good vision (baseline: mean 77.5 letters; month 36: mean 75.5 letters). Eyes with a baseline visual acuity < 20/40 significantly improved their vision by 8.2 letters on average (baseline: mean 53.1 letters; month 36: mean 61.3 letters). Better baseline visual acuity was also associated with a lower incidence of incisional IOP surgery and led to numerically fewer IOP-related events. In the eyes requiring IOP-lowering surgery (6 eyes), the IOP was managed and eyes gained 7.3 letters on average by the end of the study. The data verify that Iluvien provides physicians with a much-needed tool for safe and durable treatment of DME.