AIM
To compare real-world functional (best corrected visual acuity, BCVA) and structural (central subfoveal thickness, CST; macular volume, MV) outcomes between the two agents one month after the initial loading phase according to local treatment protocol.

 

METHODS
• Retrospective study of 135 eyes (108 patients); 93 Faricimab vs 42 Aflibercept-8 mg
• Predetermined structural outcomes: Dry macula (absence of IRF/SRF and restored foveal profile), > 20% CST reduction from baseline, and post-loading CST < or > 325 µm
• Protocol: Loading phase (3 consecutive monthly injections) with 1-month post-loading review (local protocol)
• Statistics: Linear Regression (BCVA/CST/MV) and Modified Poisson Regression Model (binary outcomes, IRR)

 

BASELINE CHARACTERISTICS
High-risk real-world cohort with significant systemic and ocular morbidity at baseline
Cardiovascular Burden:
-  20.7% had ischaemic heart disease (IHD)
-  8.1% with history of stroke
Diabetes Complications: 22.2% with history of amputation or foot ulcers
Advanced Retinopathy: 75.9% of eyes had pre-proliferative (R2) or proliferative (R3) disease at baseline

 

OVERALL COHORT RESULTS
Improvements were seen across vision, baseline thickness and macular volume outcomes in the overall cohort – all of which are statistically significant

ANCOVA LINEAR MODEL ESTIMATION OF BETWEEN-AGENT OUTCOMES
Faricimab achieved statistically significant reductions in CST, CST max, and MV, while for BCVA results there was no difference between the two agents

RELATIONSHIP BETWEEN BASELINE AND POST-LOADING CST
Statistically significant difference between Faricimab and Aflibercept-8 mg, slopes: p = 0.04
Faricimab achieved baseline-independent anatomical outcomes (consistent post-loading CST regardless of initial thickness, p = 0.1), whereas Aflibercept-8 mg showed a significant positive correlation (p < 0.001), suggesting Faricimab may be more effective for patients starting with higher macular thickness

BINARY STRUTURAL OUTCOMES (IRR)
Both agents demonstrated drying efficacy:
1.A favourable trend towards a dry macula was observed in both agents
2.Faricimab showed a higher likelihood of achieving significant anatomical targets, specifically a > 20% CST reduction and a final CST < 325 µm, with 95% CI >1.0

 

CONCLUSION
Faricimab and Aflibercept-8 mg both demonstrated favourable functional and structural outcomes. Unlike Aflibercept-8mg, Faricimab post-loading CST is unrelated to its baseline CST values. Data results favour Faricimab for achieving pre-determined better structural outcomes (CST < 325 µm, > 20% reduction in baseline CST, and marginally dry macula).

 

LIMITATIONS
Given the small sample size and short-term, post-loading nature of this assessment, these results reflect an early clinical window and warrant cautious interpretation. Longitudinal studies and larger-scale analyses, including the pooling of real-world data and meta-analyses, are essential to validate the long-term clinical relevance and durability of these findings. 

 

REFERENCES
1. Wong TY, et al. Faricimab Treat-and-Extend for Diabetic Macular Edema: Two-Year Results from the YOSEMITE and RHINE Trials. Ophthalmology. 2024;131(6):708-723.
2. Brown DM, et al. Intravitreal aflibercept 8 mg in diabetic macular oedema (PHOTON): 48-week results. Lancet. 2024;403(10432):1153-1163.