ArticleClinical ophthalmology (Auckland, N.Z.)2025
Human Factors Studies to Assess the Usability of the Faricimab Prefilled Syringe.
Article in Clinical ophthalmology (Auckland, N.Z.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05569148 (A Phase IIIb, Open-Label, Single-Arm Study in Patients With Neovascular Age-Related Macular Degeneration or Diabetic Macular Edema to Evaluate the Safety of the 6-mg Faricimab Prefilled Syringe), which is not on this map. Cited by 3 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase IIIb, Open-Label, Single-Arm Study in Patients With Neovascular Age-Related Macular Degeneration or Diabetic Macular Edema to Evaluate the Safety of the 6-mg Faricimab Prefilled Syringe
Who cites it
3 citing papers in PubMed.
- Understanding anti-vascular endothelial growth factor medications: chemical properties, costs, and side effects.Journal of medicine and life · 2026Review
- Faricimab in Treatment-Naïve nAMD: Regional UK Real-World Experience.Advances in therapy · 2026Article
- Beyond non-technical skills: training ophthalmologists to appraise and integrate emerging technologies.Eye (London, England) · 2025Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose: Faricimab, the first bispecific antibody designed for intraocular use, is approved for the treatment of neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). Here, we report the usability of a novel faricimab 6 mg pre-filled syringe (PFS) configuration that has been designed specifically for intravitreal use. Patients and Methods: A simulated-use human factors validation study enrolling 15 retina specialists and 15 ophthalmic assistants was conducted in a market research facility configured to represent an ophthalmology clinic. Participants' ability to complete tasks related to package handling, dose preparation, and injection of a faricimab 6 mg dose into a polymer eye using the PFS was assessed. In a second Phase 3b, single-arm, actual-use study, the ability of seven retina specialists and six ophthalmic assistants to prepare and administer the PFS in accordance with the instructions for use was assessed. Injections were performed into single eyes of 35 patients with nAMD or DME in three US clinics and patients were followed for 7 days for safety reporting (ClinicalTrials.gov identifier: NCT05569148). Results: In the simulated-use study, most retina specialists and ophthalmic assistants completed all tasks deemed essential for PFS preparation and administration correctly and without error. Of the 22 tasks, the pass rate was 86.7-100%; 16 tasks had a pass rate of 100%. No use errors were observed during the actual-use study. One patient experienced one mild adverse event of eye irritation that resolved the same day and was deemed unrelated to the study drug. Conclusion: Participants were able to safely and correctly prepare and administer a faricimab 6 mg dose using the PFS in accordance with the instructions for use, under realistic conditions representing the real world. The faricimab 6 mg PFS may therefore offer a more convenient, safe-handling alternative to vial administration.
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Registered trials
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