Roche has reported positive topline results from two identically designed global phase III studies, YOSEMITE and RHINE, evaluating its investigational bispecific antibody, faricimab, in people living with diabetic macular edema (DME).
Both studies met their primary endpoint and showed that faricimab given every eight weeks and at personalised dosing intervals of up to 16 weeks demonstrated non-inferior visual acuity gains compared to aflibercept given every eight weeks. Faricimab was generally well-tolerated, with no new safety signals identified. The studies each have three treatment arms, with participants randomised to receive either faricimab or aflibercept at fixed eight-week intervals, or faricimab at personalised intervals of up to 16 weeks, following a loading phase.
more than half of participants in the faricimab personalised dosing arms achieved an extended time between treatments of 16 weeks at year one
In a secondary endpoint, across both studies, more than half of participants in the faricimab personalised dosing arms achieved an extended time between treatments of 16 weeks at year one. Roche stated that this is the first time any investigational medicine has achieved this level of durability in a phase III study of people with DME.
Worldwide, an estimated 21 million people are living with DME, a leading cause of vision loss among working-age adults.1 While anti-vascular endothelial growth factor (VEGF) monotherapy injections have significantly reduced vision loss from DME, the treatment burden associated with frequent eye injections and physician visits can lead to under-treatment and, potentially, less than optimal vision outcomes.2,3 Faricimab is the first investigational bispecific antibody designed for the eye.4 It targets two distinct pathways – via angiopoietin-2 (Ang-2) and VEGF-A – that drive a number of retinal conditions, including DME.5
“These positive results show that faricimab has the potential to offer lasting vision improvements for people with diabetic macular oedema, while also reducing the treatment burden associated with frequent eye injections,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We look forward to discussions with global regulatory authorities, with the aim of bringing this potential new treatment option to people with this condition as soon as possible.”
In addition to the YOSEMITE and RHINE studies, the phase III Rhone-X study is investigating the long-term safety and tolerability of faricimab for the treatment of DME.6 Faricimab is also being studied in the phase III TENAYA and LUCERNE studies as a potential treatment for neovascular or wet age-related macular degeneration (nAMD).7,8,9,10 Detailed results from the YOSEMITE and RHINE studies will be presented in February at Angiogenesis, Exudation, and Degeneration 2021, a medical symposium presented by Bascom Palmer Eye Institute of the University of Miami Miller School of Medicine, and submitted for approval for the treatment of DME around the world.
1. Yau JWY, et al. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012;35:556-64.
2. Zhao Y, Singh, RP. The role of anti-vascular endothelial growth factor (anti-VEGF) in the management of proliferative diabetic retinopathy. Drugs in Context. 2018;7:212532.
3. Sahni J, et al. Simultaneous inhibition of angiopoietin-2 and vascular endothelial growth factor-A with faricimab in diabetic macular edema. American Academy of Ophthalmology. 2019;126:1155–70.
4. Roche data on file.
5. Khan M, et al. Targeting Angiopoietin in retinal vascular diseases: A literature review and summary of clinical trials involving faricimab. Cells. 2020;9(8):1869.
6. Clinical Trials.gov. A study to evaluate the long-term safety and tolerability of faricimab in participants with diabetic macular edema (Rhone-X) [Internet; cited 2020 November]. Available from: https://clinicaltrials.gov/ct2/show/NCT04432831.
7. Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab in participants with neovascular age-related macular degeneration (TENAYA) [Internet; cited 2020 November]. Available from: https://clinicaltrials.gov/ct2/show/NCT03823287.
8. Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab in participants with neovascular age-related macular degeneration (LUCERNE) [Internet; cited 2020 November]. Available from: https://clinicaltrials.gov/ct2/show/NCT03823300.
9. Pennington KL, DeAngelis MM. Epidemiology of age-related macular degeneration (AMD): associations with cardiovascular disease phenotypes and lipid factors. Eye and Vision. 2016;3:34.