New research has found that the fluocinolone acetonide intravitreal implant, known as ILUVIEN, can effectively improve visual and anatomical outcomes in eyes with diabetic macular edema (DME) that do not respond adequately to prior treatments. The study, led by José María Ruiz-Moreno from the University of Castilla La Mancha in Spain, showed that there was a statistically significant improvement in best-corrected visual acuity (BCVA) at month 24 after the implant in eyes with a baseline BCVA of ≤70 ETDRS letters. Eyes with a baseline BCVA ≥50 letters also experienced greater anatomic improvement after treatment.
In cases where therapies using vascular endothelial growth factor (VEGF) inhibitors are ineffective or contraindicated, intravitreal corticosteroid implants, such as the fluocinolone acetonide sustained-release implant, could be a viable treatment option. This non-erodible implant delivers a sustained daily dose of fluocinolone acetonide over a period of 3 years.
Previous studies have demonstrated the long-term benefits of the fluocinolone acetonide implant in eyes with DME that were unresponsive to other therapies. The ILUVIEN Registry Safety study showed significant improvements in BCVA, particularly in eyes with a shorter duration of DME, and reported no unexpected adverse events. The PALADIN study also demonstrated positive outcomes in both visual and anatomical measures, along with a good safety profile.
The current phase 4 REACT trial aimed to assess the effectiveness and safety of the fluocinolone acetonide implant in patients with chronic DME who did not respond sufficiently to other treatments. The trial included 31 eyes from 31 patients, and the primary endpoint was the mean change in BCVA from baseline. Secondary endpoints included changes in central subfield thickness (CST), macular volume, adverse events, and patient-reported outcomes.
The results of the trial showed that while there was an overall improvement in BCVA from baseline to 24 months, it was not statistically significant. However, in eyes with a baseline BCVA ≤70 ETDRS letters, there was a significant improvement in BCVA after treatment. Anatomically, there was a significant reduction in CST and macular volume in the study population. Safety data indicated that 24.2% of reported adverse events were potentially related to the study medication.
It is worth noting that the study was originally planned to include 40 eyes, but the COVID-19 pandemic disrupted healthcare delivery, which may have impacted the lack of statistical significance in BCVA improvement at 24 months.
Overall, the research demonstrates the potential benefits of the fluocinolone acetonide intravitreal implant in improving visual and anatomical outcomes for patients with DME who have not responded adequately to other therapies.
– Ruiz-Moreno, J.M., Adán, A., Lafuente, M. et al. Effectiveness and safety of fluocinolone acetonide intravitreal implant in diabetic macular edema patients considered insufficiently responsive to available therapies (REACT): a prospective, non-randomized, and multicenter study. Int Ophthalmol (2023).
– Iapoce C. PALADIN: Fluocinolone Acetonide Implant Associated with Stable Intraocular Pressure. HCP Live. September 7, 2023.