Clinical researchers at the NHS Foundation Trust, Sheffield, UK have found that real-world evidence on the effectiveness and safety of a fluocinolone acetonide (FAc) implant supports a clinical impact reduction in the number of hospital visits over 3 years. The researchers concluded that a total of 570 visits prior to FAc implant was reduced to 462 visits post-FAc injection. Research at the BMJ (British Medical Journal, BMJ Open Ophth 2020; 5: e000484) commented that “the findings from this case series demonstrate the effectiveness and safety of the FAc 0.2 μg/day implant in a real-world clinical practice in patients with DMO that persists or recurs despite treatment. Patients treated with the FAc implant demonstrated rapid and sustained improvements in BRVA and CMT. These were accompanied by reduced treatment burden and associated clinic treatment visits”.
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 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, results showed 26 eyes of patients (n=22) with recurrent or persistent DMO were identified and were treated for 36 months (4 patients received bilateral treatment). The researchers assessed 24 and 36 months and reported that 86.4% and 75.0% of patients maintained or gained vision post-FAc implant in routine clinical practice. The mean BRVA increased from 41.8 to 54.6 letters at month 24 and 45.8 letters at month 36, with 50.0% and 33.3% of patients achieving a ≥15 letter improvement at months 24 and 36, respectively. The mean CMT reduced from 600.8 μm at baseline to 351.0 μm and 392.5 μm at months 24 and 36,respectively. Overall, a mean of one treatment every 13.33 months post-FAc implant (vs 3.24 months pre-FAc implant) was reported.
The study concluded that, “on average, fewer injections of anti-VEGF agents and corticosteroids were required after the FAc implant was administered, therefore helping to reduce patient, clinician and clinic treatment burden. From a clinical perspective, the reduced CMT post-FAc implant correlates with the decreased treatment frequency, where the mean number of treatments per month was reduced. Furthermore, the calculation of hospital visits showed a reduction in the total number of hospital visits over 3 years, from 570 visits prior to FAc implant to 462 visits post-FAc implant. These findings are comparable with those reported in other real-world studies following treatment with the FAc implant”.