Twelve-Month Outcomes of Faricimab for Patients with Sub-Optimally Responsive Diabetic Macular Oedema: A Retrospective Single-Centre Study.

Abstract

Purpose: To evaluate the visual and anatomical outcomes of switching diabetic macular oedema (DMO) patients with suboptimal response to aflibercept 2mg to faricimab over a 12-month period.

Patients and methods: This retrospective single centre study enrolled 62 eyes from 50 patients with diabetic macular oedema (DMO) who demonstrated a sub-optimal response to aflibercept 2mg. Sub-optimal response was defined by a central subfield thickness (CST) exceeding 325µm or greater than 20% increase from the best CST despite receiving aflibercept 2mg at intervals of 8 weeks or less. Patients had received at least six 4-weekly doses of aflibercept 2mg. Faricimab was administered as four intravitreal loading injections at 4-weekly intervals, followed by a treat-and-extend approach. Outcome measures, including best-recorded visual acuity (BRVA), CST, and treatment intervals, were assessed at baseline, post-loading (6.5 ± 1.9 weeks) and at the latest clinic review (57.1 ± 19.7 weeks). Statistical analysis included paired t-tests (normal distribution) and Wilcoxon signed-rank tests (non-normal distribution), with p < 0.05 considered statistically significant.

Results: Mean age was 63.9 (±11.4) years, 56% participants were male. At baseline, the mean BRVA was 67.6 (±11.8) letters, and CST measured 406.4 (±105.9) µm. The initial mean treatment interval was 6.5 (±1.8) weeks. BRVA increased to 70.4 (±12.7) letters (p=0.008), while CST reduced to 372.8 (±132.0) µm (p=0.002). The mean injection interval extended to 7.4 (±2.6) weeks (p=0.03). At the latest follow-up BRVA was maintained at 68.7 (±14.6) letters (p=0.572), and CST reduced further to 343.1 (±117.5) µm (p=0.020). At the final follow-up 53.2% were on ≥8-weekly intervals. The mean injection interval increased to 9.2 (±3.2) weeks (p < 0.001), and a mean of 7.92 (±2.53) faricimab injections was administered.

Conclusion: DMO patients with sub-optimal response to aflibercept 2mg experienced improved anatomical outcomes and extended treatment intervals while maintaining vision on faricimab, with no new safety concerns.