Implant Showed Sustained Anatomical, Visual Benefits in DME

The long-acting therapeutic option of the fluocinolone acetonide (FAc) intravitreal implant can be used with sustainable benefits in patients with diabetic macular edema (DME) according to a new study published in Ophthalmology Therapy.¹ The treatment can be used in patients with both chronic or recurrent DME and alongside topical therapy in some instances.

DME is one of the leading causes of visual impairment in adults of working age, affecting 18.8 million individuals around the world. DME is characterized by the swelling of the central part of the retina in the eye, which can affect the ability to see fine details.² Standard treatment includes the use of anti-vascular endothelial growth factor (VEGF) injections and corticosteroids. However, these can be hard when it comes to adherence, as injections need to be received every few months. The 0.19 FAc intravitreal implant aims to address some of these problems by allowing for corticosteroid delivery in the eye for up to 3 years. This study aimed to assess how effective the implant was in the long term in a real-world cohort of patients with DME.

The study was retrospective and enrolled patients from a single center who were treated with the 0.19 mg FAc implant after a diagnosis of refractory DME. Patients were treated between January 26, 2016, and November 14, 2024. Patients who were aged 18 years or older and were diagnosed with refractory DME were included in this study. Patients were considered as having refractory DME if they had a central retinal thickness (CRT) of more than 300 μm and had a reduction of 10% or less after 6 months of follow-up despite treatment with anti-VEGF injections. Patients with macular edema outside of DME or who had glaucoma that was not controlled were excluded from the study.

The primary outcome of the study was the mean change in CRT and best-corrected visual acuity (BCVA) when looking at the last follow-up visit compared with baseline. The proportion of patients achieving a CRT of 300 μm or less and the proportion of patients with a reduction of CRT of 20% or more acted as secondary outcomes in the study. Incidence of treatment-emergent adverse events and frequency of adjunctive treatments for DME were also considered as secondary outcomes.

There were 49 eyes from 39 patients that were included in the study. The mean (SD) age of the population was 70.4 (9.8) years, and the mean duration of DME was 9.1 (3.2) years before treatment with the FAc implant. All eyes had previously received corticosteroids or anti-VEGF treatment. The median (IQR) follow-up was 24.0 (12.0-36.0) months in all of the patients, and 20 eyes completed 36 months of follow-up.

The mean CRT of the patients decreased from 502.1 (154.0) μm to 325.6 (102.9) μm from baseline to the last follow-up visit. A total of 27 eyes were able to achieve a CRT of 300 μm or less, and a CRT reduction of 20% or more was achieved in 43 eyes. Mean BCVA also saw improvements in patients, starting at 47.3 (18.2) letters at baseline and improving to 54.9 (14.7) letters at the last follow-up visit. A total of 40 eyes reported that BCVA was maintained or improved at the last follow-up visit, and 13 eyes experienced gains of 15 or more letters. A total of 13 eyes needed to be treated with anti-VEGF, corticosteroids, or laser photocoagulation during the study period; no eye required a second implant. Mean intraocular pressure did not significantly differ from the baseline measurements at any point in time.

There were some limitations to this study. The retrospective design of the study and all patients coming from a single center could have introduced selection bias and reduced generalizability. Variables from optical coherence tomography measures were not available and could have limited an assessment of treatment response. The analysis also had limited ability to assess for infrequent adverse events, small effects, and subgroup analyses.

“The 0.19 mg FAc implant demonstrated sustained efficacy and an acceptable safety profile in patients with chronic [DME],” the authors concluded. “…Overall these findings support the role of the FAc implant as a long-acting therapeutic option for chronic or recurrent DME and add real-world evidence to its sustained effectiveness and safety.”

References

1. Cabanas JC, Cardoso DF, Ferreira CC, et al. Efficacy and safety outcomes of fluocinolone acetonide intravitreal implant in refractory diabetic macular edema: a real-world study. Ophthalmol Ther. Published online June 2, 2026. doi:10.1007/s40123-026-01409-x
2. Diabetes-related macular edema. Cleveland Clinic. Updated February 14, 2023. Accessed June 3, 2026. https://my.clevelandclinic.org/health/diseases/24733-diabetes-related-macular-edema