Researchers at the Birmingham and Midland Eye Centre, UK, has reported five-years’ of real-world results from the application of the fluocinolone acetonide implant (ILUVIEN), for the treatment of chronic diabetic macular oedema (DMO)(doi.org/10.1038/s41433-022-02338-2). Following their analysis, two-thirds of eyes (from a total of n=60 eyes) demonstrated improved or stable visual acuity over 5 years, and an overall sustained improvement in anatomical outcomes. While common adverse effects of the implant were reported for IOP, the UK researchers showed that the proportion of eyes on topical IOP-lowering medication at the 5-year endpoint (70% after 5 years vs. 16% at baseline) was significantly higher than that reported in other studies. In conclusion, the study reported a demonstration of “a 69% reduction in intravitreal treatment frequency following treatment with the ILUVIEN implant in a real-world setting”.
Originally, fluocinolone acetonide (FAc) implant (ILUVIEN) received approval from the FDA and EMA in 2014 for its sustained release for the treatment of diabetic macular oedema (DMO). The treatment comprises an intravitreal cylindrical polyimide tube containing <200ug (0.19mg) of the corticosteroid surgically inserted in the eye designed to provide for a low dose sustained release of FAc for up to 36 months. According to the recent real-world data, BCVA at baseline ranged from 0 to 76 letters, with a mean of 48.1(±16) letters, which improved to 52.3 (±17) letters after one-year (a gain of +4.2 letters) before gradually reducing back down to 48.3 (±23) letters at 5 years. The change in BCVA at 1-year was statistically significant (p < 0.05), but it was not statistically significant at 2-, 3-, and 5-year follow-up. In brief, according to the researchers, “five years after treatment with ILUVIEN, 13 eyes had an improved BCVA of 5 letters or more compared to baseline, 8 eyes had a similar BCVA as baseline (+/− 4 letters from baseline), and 10 eyes had a worse BCVA with a loss of 5 letters or more compared to baseline. This means that 68% of eyes had a similar or improved BCVA after 5 years when compared to baseline. The proportion of eyes achieving a BCVA of 60 letters or more (6/18 Snellen equivalent) increased from 29% at baseline to 42% at 1-year, before reducing to 39% at 2- and 3-year, and 35% at 5-year post-ILUVIEN.
Commenting on the outcomes of the real-world data, the researchers’ have commented that the study “suggests that intravitreal ILUVIEN fluocinolone acetonide 0.19 mg sustained-release implant is a safe and effective treatment option for the treatment of chronic DMO in patients with a pseudophakic lens. We observed a significant improvement in both functional and anatomical outcomes one year after treatment, and after 5 years around two-thirds of eyes had the same or better visual acuity than at baseline, with a sustained reduction in CRT.”