The Lancet has published two papers highlighting one-year results from four pivotal phase III studies of faricimab, an investigational bispecific antibody, in neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular oedema (DME).1,2 All four studies – which enrolled more than 3,000 people in total – met their primary endpoints, showing that people treated with faricimab, up to every four months, achieved non-inferior vision gains compared to aflibercept, given every two months. Notably, about half of eligible faricimab patients were able to go four months between treatments in the first year, and approximately three-quarters could go three months or longer in the TENAYA and LUCERNE nAMD studies and the YOSEMITE and RHINE DME studies.1,2 The current standard of care for these potentially blinding conditions requires eye injections as often as once a month.3,4
“These data published in The Lancet reinforce the potential of faricimab as an important treatment option that may help improve and maintain vision while extending the time between treatments up to four months,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development.
If approved, faricimab would be the first bispecific antibody for the eye, targeting and inhibiting two distinct pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).5 Inhibition of both pathways has been shown to have potentially complementary benefits, stabilising vessels and thereby reducing vessel leakage and inflammation more than inhibition of the VEGF-A pathway alone.6
- Heier, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. The Lancet. 2022; doi.org/10.1016/S0140-6736(22)00010-1.
- Wykoff et al. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with DME (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. The Lancet. 2022; https://doi.org/10.1016/S0140-6736(22)00018-6.
- Highlights of prescribing information, Lucentis. 2012 [Internet; cited January 2022]. Available from: www.accessdata.fda.gov/drugsatfda_docs/label/2012/125156s0069s0076lbl.pdf.
- Highlights of prescribing information, Eylea. 2011 [Internet; cited January 2022]. Available from: www.accessdata.fda.gov/drugsatfda_docs/label/2011/125387lbl.pdf.
- Sharma, et al. Faricimab phase 3 DME trial significance of personalized treatment intervals (PTI) regime for future DME trials. Eye. 2021; doi.org/10.1038/s41433-021-01831-4.
- Heier JS, et al. The Angiopoietin/Tie pathway in retinal vascular diseases: a review. Retina-J Ret Vit Dis. 2021;41:1-19.