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Peer-reviewedCC BY 4.0Frontiers in Pharmacology

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

  • Georgios D. Panos1,2
  1. 1Department of Ophthalmology, AHEPA University Hospital, School of Medicine, Aristotle University of Thessaloniki
  2. 2Division of Ophthalmology and Visual Sciences, School of Medicine, University of Nottingham
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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.

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Cite

BibTeXRIS
BibTeX
@article{panos2026faricimab,
  title = {{Faricimab 6 mg versus aflibercept 8 mg in diabetic macular oedema: an in silico study of anchored efficacy and common-protocol treatment burden}},
  author = {Georgios D. Panos},
  journal = {Frontiers in Pharmacology},
  year = {2026},
  month = oct,
  doi = {10.3389/fphar.2026.1938908},
  url = {https://www.frontiersin.org/articles/10.3389/fphar.2026.1938908/full},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Faricimab 6 mg versus aflibercept 8 mg in diabetic macular oedema: an in silico study of anchored efficacy and common-protocol treatment burden
AU  - Georgios D. Panos
PY  - 2026
DA  - 2026/10/13
JO  - Frontiers in Pharmacology
DO  - 10.3389/fphar.2026.1938908
UR  - https://www.frontiersin.org/articles/10.3389/fphar.2026.1938908/full
AB  - 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.
SN  - 1663-9812
ER  -