Beyond the First Year of Intravitreal Faricimab for Diabetic Macular Oedema: A Single-Centre Experience

Abstract

Objective To determine real-world clinical outcomes (including vision, anatomy and durability) of intravitreal faricimab (IVF) in year two (up to mean follow-up of 75 ± 15 weeks, range: 52-103 weeks) of treating diabetic macular oedema (DMO). Secondary objectives included assessing changes in diabetic retinopathy (DR) severity, the incidence of epiretinal proliferation (ERP)/epiretinal membrane (ERM), and safety. Methodology This is a single-centre retrospective observational study. Eligible eyes with ≥52 weeks follow-up, October 2022 to November 2024, were identified and categorised into naïve (no prior anti-vascular endothelial growth factor (anti-VEGF) agents) and switch (≥1 prior anti-VEGF). Descriptive statistics at week 52 (W52) and end of follow-up (EOFU) summarised mean BCVA and CFT change, mean IVF injections and frequency, DR severity change, epiretinal proliferation (ERP)/membrane (ERM) incidence, and safety. Results In total, 158 eyes (66 naïve, 92 switch) of 118 patients were identified, mean follow of 75 weeks. Mean W52 BCVA change was +3.6 (P = 0.04) for naïve and +1.3 letters (P = 0.34) for switch eyes; mean CFT reduction was -141 μm (P < 0.0001) and -115 μm (P < 0.0001), respectively. At EOFU, 27 (63%) naïve eyes and 36 (55%) switch eyes received IVF ≥12 weekly. In switch eyes, the mean W52 IVF interval was 11 weeks versus 7 with prior anti-VEGF agents (P < 0.0001). Of 115 available images, DR severity regressed or was stable in 111 (97%). ERP/ERM was developed in 10/39 (25.6%) naïve and 14/41 (34.1%) switch eyes. No safety outcomes were ever reported. Conclusions Faricimab demonstrated significant structural improvement and durability, with BCVA stability maintained into the second year of treatment. Most eyes showed regression or stability of DR with moderate ERP/ERM incidence.

Keywords: anti-vegf treatment; diabetic macular edema (dme); diabetic macular oedema; faricimab; faricimab intravitreal injenction; intravitreal anti vegf; intravitreal injections; real-world; real-world data.

Figure 1. Mean BCVA (A) and CFT (B) in naïve and switch eyes at baseline, W52 and EOFU.

Error bars represent standard deviation. The differences between means here vary slightly from the manuscript text because baseline, W52 and EOFU means here were calculated from all 158, 149 and 144 eyes, respectively, whereas results in the study do not include baseline data for the eyes excluded from data analyses (Table 3). BCVA, best-corrected visual acuity; CFT, central foveal thickness; EOFU, end of follow-up; ETDRS, Early Treatment Diabetic Retinopathy Study; W52, week 52

Figure 2. Intervals between IVF injections at W52 and EOFU in naïve and switch eyes.

IVF, intravitreal faricimab; EOFU, end of follow-up

Figure 3. DR severity at baseline, W52 and EOFU in naïve and switch eyes.

DR, diabetic retinopathy; PDR, proliferative diabetic retinopathy; EOFU, end of follow-up