Roche Announces Faricimab Meets Primary Endpoint in Two Global Phase III Trials for Diabetic Macular Edema

Roche announced today that its investigational bispecific antibody, faricimab, met the primary endpoints in two global Phase 3 clinical trials evaluating patients with diabetic macular edema (DME). Faricimab demonstrated non-inferiority compared to approved vascular endothelial growth factor (VEGF) inhibitors. Faricimab is a bispecific antibody that simultaneously targets VEGF-A and angiopoietin-2 (Ang-2).

Diabetic macular edema affects approximately 21 million people worldwide and is a leading cause of vision loss among working-age adults. Diabetic retinopathy (DR) occurs when vascular damage and neovascularization lead to leakage of blood and/or fluid into the retina. Diabetic macular edema (DME) develops when damaged vessels cause swelling in the macula, the central region of the retina responsible for the sharp visual acuity required for activities such as reading and driving. Although monotherapy with intravitreal injections of vascular endothelial growth factor inhibitors can significantly reduce vision loss associated with DME, the treatment burden related to frequent ocular injections and clinic visits may result in undertreatment.

The press release stated that faricimab is the first investigational bispecific antibody designed specifically for the eye. It targets two distinct pathways, Ang-2 and VEGF-A. Ang-2 and VEGF-A compromise vascular stability, leading to the formation of new leaky blood vessels and increased inflammation, thereby affecting vision. By blocking both pathways, faricimab aims to stabilize blood vessels, potentially offering better long-term visual outcomes for individuals with retinal diseases.

▲Schematic diagram of the structure of faricimab (Image source: Reference [2])

These two randomized, double-blind, global Phase 3 clinical trials enrolled a total of 1,891 patients with diabetic macular edema (DME). The patients were divided into three groups: one group received injections of an approved VEGF inhibitor every 8 weeks; another group received faricimab injections every 8 weeks; and the third group received individualized faricimab injection regimens, with dosing intervals extended up to a maximum of 16 weeks.

The trial results demonstrated that faricimab administered every 8 weeks met the non-inferiority criteria compared with approved VEGF inhibitors. Meanwhile, more than half of the participants in the individualized dosing group had their treatment intervals extended to 16 weeks during the first year of therapy. This marks the first time an investigational drug for diabetic macular edema (DME) has achieved this level of durability in a Phase 3 clinical trial.

References:

[1] Roche’s faricimab meets primary endpoint and shows strong durability across two global phase III studies for diabetic macular edema, a leading cause of blindness. Retrieved December 21, 2020, from https://www.roche.com/media/releases/med-cor-2020-12-21.htm

[2] Sharma et al., (2019). Faricimab: expanding horizon beyond VEGF. Eye, https://doi.org/10.1038/s41433-019-0670-1

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