Background Neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) represent the leading causes of vision impairment and blindness among the elderly population and people with diabetes, respectively. To reduce disease burden and improve disease management, highly effective therapies and optimal treatment are of major importance. In September 2022, faricimab was approved for the treatment of nAMD and DME in Germany, allowing a treatment approach with dual Ang-2/VEGF-inhibition. This research project was conducted to investigate the clinical care and therapeutic practice in German nAMD and DME patients. Furthermore, by evaluating upload patterns in real-world practice, this study aimed to assess the use of faricimab in treatment-naive patients who received faricimab as a first-line treatment at these centers. Data on visual acuity and drying of the retina was collected in a descriptive manner.

Methods ZEUS is a multicenter retrospective analysis of anonymized routinely collected data on patients with nAMD or DME who have been treated with intravitreal injections (IVT) between October 2022 and September 2024. A total of 24 sites (ophthalmologic practices or centers) across Germany reported predominant IVT regimen, drug upload strategies and diagnostic imaging techniques used in the routine care of patients with nAMD and DME in an electronic case report form (eCRF). For the subset of IVT injection-naive patients receiving faricimab data were extracted from patient charts and entered in an anonymized aggregated form into eCRF. Analysis included proportion of IVT injection-naive patients treated with faricimab in first-line, baseline characteristics of these patients/eyes, and reduction of fluid in the macula and changes in visual acuity during faricimab upload phase.

Results The majority of sites (62.5%) applied a treat-and-extent (T&E) regimen, regardless of the chosen IVT. In case of faricimab the predominant upload scheme was 4 injections applied by 50% of sites, compared to three injections for other IVTs (58.3%) depending on the disease (nAMD/DME). OCT displayed the standard diagnostic at all sites (100.0%), other diagnostic procedures such as fluorescein angiography (FA, 62.5%) and OCT-A (25%) were applied less often. Out of the 24 sites, more than half initiated faricimab as first-line therapy in ≥20% of patients. More than 20% achieved a CRT reduction of either 40-60%, 20-40% or 0-20% during faricimab upload; a reduction of more than 80% was achieved in 14.4% of nAMD eyes. The majority of DME eyes (43.9%) displayed a CRT reduction of 20-40%. In the faricimab upload phase, absence of IRF was achieved in 67.2% of nAMD eyes, while an absence of only SRF and both IRF and SRF was seen in 65.0% and 56.7% of eyes. Approximately 80% of DME eyes were free of SRF in the upload phase. The main reason for using faricimab as first-line therapy was to achieve an increase in injection intervals and best effectiveness. Discontinuation rates were low.

Conclusion This is the first analysis of general nAMD and DME treatment modalities as well as real-world effectiveness of faricimab in a large cohort of treatment-naive patients in Germany. Sites prefer individual approaches based on patients’ needs. First-line treatment with faricimab resulted in visual acuity gain during the faricimab upload phase in a real-world setting. These findings may help to better understand treatment strategies and first-line use of faricimab in nAMD and DME in Germany.

AJ Augustin received travel support, consulting fees and payment or honoraria for lectures, presentations, speakers bureaus from Bayer, Roche, Lumithera, Samsara, Abbvie. FF Theine received travel support, consulting fees and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Roche. H Kaymak received consulting fees from Roche, Zeiss, OmniVision, J&J, Haag-Streit, Santen and HOYA, payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Roche, Zeiss, J&J, HOYA, OmniVision and Santen, travel support from Zeiss, HOYA, Santen, Roche and J&J, and participated on Advisory Boards of Roche, HOYA and Santen. J Clauss received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Roche, travel support from Roche and Bayer, and participated on Advisory Boards of Roche. T Schimitzek has no competing interests to declare. M Zortel and S Bluemich are employees and stockholders of Roche Pharma AG. A Sader-Moritz received consulting fees from Essilor, payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Roche, Novartis, Abbvie, Alimera, Bayer and Thieme, travel support from Roche, Novartis, Abbvie, Alimera, Bayer, Essilor, and participated on Advisory Boards of Roche and Bayer. Medical writing assistance was provided by med:unit GmbH, Germany, and was funded by Roche Pharma AG. The authors had full editorial control and gave their final approval.

https://drks.de/search/en/trial/DRKS00035007

This research project was funded by Roche Pharma AG, Germany.

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