Roche Announces Positive Phase III Results for Faricimab in Neovascular Age-Related Macular Degeneration

On January 25, Roche announced that its bispecific antibody faricimab achieved positive topline results in two global Phase 3 clinical trials, TENAYA and LUCERNE, for the treatment of patients with neovascular age-related macular degeneration (nAMD). Faricimab is a bispecific antibody that simultaneously targets VEGF-A and angiopoietin-2 (Ang-2).

nAMD affects approximately 20 million people worldwide and is the leading cause of blindness in individuals aged 60 years and older. The current standard of care involves intravitreal injections of vascular endothelial growth factor (VEGF) inhibitors, which can significantly reduce vision loss associated with nAMD. However, VEGF is not the sole factor driving the onset and progression of the disease. Furthermore, patients with nAMD receiving anti-VEGF monotherapy typically require monthly intravitreal injections administered by an ophthalmologist. As noted in the press release, faricimab is the first investigational bispecific antibody specifically designed for ocular use. It targets two distinct pathways, Angiopoietin-2 (Ang-2) and VEGF-A, which contribute to vision impairment by destabilizing blood vessels, promoting the formation of new leaky vessels, and increasing inflammation. By blocking both pathways, faricimab aims to stabilize blood vessels, potentially offering better long-term visual outcomes for individuals with retinal diseases.

TENAYA and LUCERNE were two identical, randomized, double-blind, global Phase 3 clinical studies that evaluated the efficacy and safety of faricimab compared with an active VEGF inhibitor control in 1,329 patients with neovascular age-related macular degeneration (nAMD). The primary endpoint was the mean change in best-corrected visual acuity (BCVA) score from baseline to Week 48. Both studies met their primary endpoints, demonstrating that visual outcomes in patients treated with faricimab were non-inferior to those in the active control group (administered once every 8 weeks). In both studies, nearly half (45%) of the patients received faricimab once every 16 weeks during the first year, marking the first time an intravitreal injection therapy for nAMD has achieved such extended durability in Phase 3 clinical trials.

Dr. Levi Garraway, Chief Medical Officer and Global Head of Product Development at Roche, stated, “These results demonstrate the potential of faricimab, as an innovative class of medicine, to extend treatment intervals for patients with neovascular age-related macular degeneration (nAMD). We have observed positive and consistent outcomes across four Phase 3 clinical trials of faricimab for the treatment of nAMD and diabetic macular edema. We look forward to submitting these data to regulatory authorities worldwide to bring this promising treatment option to patients as soon as possible.”

Note: This article is intended to introduce medical and health research and does not constitute a recommendation for treatment plans. For guidance on treatment options, please consult a licensed healthcare provider at an accredited hospital.

References:

[1] Roche’s faricimab meets primary endpoint in two global phase III studies and shows potential to extend time between treatments up to 16 weeks for people with neovascular age-related macular degeneration. Retrieved January 25, 2021, from https://www.roche.com/media/releases/med-cor-2021-01-25.htm

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