Work

Faricimab 6 mg versus aflibercept 8 mg in diabetic macular oedema: an in silico study of anchored efficacy and common-protocol treatment burden

Year: 2026

Type: article

Abstract: Background: No prospective randomised head-to-head trial has compared faricimab 6 mg with aflibercept 8 mg for diabetic macular oedema (DMO). Their pivotal programmes used materially different dosing architectures, precluding interpretation of observed interval distributions as drug properties. Methods: We separated an anchored Bayesian aggregate-data comparison of year-1 and year-2 best-corrected visual acuity (BCVA) and retinal-thickness differences from an individual-level, discrete-time burden microsimulation. The latter applied identical three-dose loading and Q4W-Q16W rules, conditional on transported durability evidence. Protocol standardisation applied only to burden; dosing history did not generate efficacy. Inputs represented mixed pivotal-trial populations. Structural, prior, composite leave-out, qualification and calibration analyses were performed. Results: The estimated BCVA difference between treatments was small and compatible with no treatment difference: faricimab minus aflibercept 8 mg was +1.22 letters at year 1 (95% uncertainty interval [UI], -0.48 to +2.86) and +0.41 at year 2 (-1.43 to +2.27). Retinal-thickness-reduction differences were +21.93 μm at year 1 (+1.70 to +42.52; P[Δ > 0] = 98.3%) and +20.53 μm at year 2 (-1.08 to +42.24); the year-2 interval included zero, and estimates varied across structures. Under the common simulated treat-and-extend regimen, aflibercept 8 mg was projected to require fewer injections than faricimab (7.29 vs. 8.01 by week 52 and 10.93 vs. 12.60 by week 104). A greater proportion of simulated eyes receiving aflibercept 8 mg than faricimab reached 16-week dosing intervals (80.2% vs. 50.9% at week 52 and 77.7% vs. 60.4% at week 104). Aflibercept 8 mg showed a lower estimated injection burden, although the adjusted range included no difference between treatments. Conclusion: The estimated BCVA differences were small and compatible with no treatment difference. Faricimab showed greater anatomical improvement at year 1, while the year-2 estimate included no difference. Aflibercept 8 mg showed a lower simulated injection burden, although the adjusted range included no difference. Neither treatment demonstrated clinical superiority.

Source: Frontiers in Pharmacology

DOI: 10.3389/fphar.2026.1938908

Author: Georgios D. Panos

Institutions: University of Nottingham, Aristotle University of Thessaloniki, AHEPA University Hospital

Language: English

Topic: Retinal Diseases and Treatments

Subfield: Ophthalmology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $3,801