Roche recently announced that 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 Edema (DME). 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, Roche notified via a statement.
The statement also said that the current standard of care for these potentially-blinding conditions requires eye injections as often as once a month.
If approved, Faricimab would be the first bispecific antibody for the eye, targetting 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). 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, the statement further mentioned.
It informed that in the Tenaya and Lucerne studies in nAMD, the average vision gains from baseline at one-year in the Faricimab arms were +5.8 and +6.6 letters, respectively, compared to +5.1 and +6.6 letters in the Aflibercept arms. The studies also measured the proportion of people in the Faricimab arm that were treated on dosing schedules of every three or four months during the first year. Importantly, 46 per cent (n=144/315) of patients in Tenaya and 45 per cent (n=142/316) in Lucerne were able to be treated every four months in the first year. An additional 34 per cent (n=107/315) of patients in Tenaya and 33 per cent (n=104/316) in Lucerne were able to be treated every three months.
Combined, nearly 80 per cent of Faricimab-treated patients were able to go three months or longer between treatments during the first year. Consistent with vision outcomes, Faricimab treatment resulted in a meaningful and comparable reduction in Central Subfield Thickness (CST) and comparable decreases in choroidal neovascularisation lesion size and area. Faricimab was generally well-tolerated in both studies, with a favourable benefit-risk profile. Ocular Adverse Events (AEs) were comparable across treatment arms and consistent with those expected with intra-vitreal anti-VEGF injections in patients with nAMD, it added.
The statement also noted that in the Yosemite and Rhine studies in DME, the average vision gains from baseline at one-year were +11.6 and +10.8 eye chart letters in the Faricimab treat-and-extend arms, +10.7 and +11.8 letters in the two-month arms and +10.9 and +10.3 letters in the Aflibercept arms, respectively. A secondary endpoint in both studies measured the proportion of people in the Faricimab treat-and-extend arms that achieved dosing schedules of every three or four months at the end of the first year. Importantly, 53 per cent (n=151/286) of Faricimab treat-and-extend patients in Yosemite and 51 per cent (n=157/308) in Rhine achieved four-month dosing at one-year. An additional 21 per cent (n=60/286) of Faricimab treat-and-extend patients in Yosemite and 20 per cent (n=62/308) in Rhine achieved three-month dosing.
It further said that when combined, more than 70 per cent of Faricimab treat-and-extend patients were able to go three months or longer between treatments at the end of the first year. Reductions in CST and resolution of intra-retinal fluid through the first year consistently favoured Faricimab over Aflibercept. Faricimab was generally well-tolerated in both studies, with a favourable benefit-risk profile. Ocular AEs were comparable across treatment arms and consistent with those expected with intra-vitreal anti-VEGF injections in patients with DME.
Faricimab is currently under review by the US Food and Drug Administration (FDA) for the treatment of nAMD and DME. The European Medicines Agency (EMA) is also currently evaluating the Faricimab Marketing Authorisation Application for the treatment of nAMD and DME. Additionally, the Comino and Balaton trials are underway, evaluating the efficacy and safety of Faricimab in people with macular edema following retinal vein occlusion, it further notified.
Two-year results for Faricimab in DME will be presented at the Angiogenesis, Exudation, and Degeneration 2022 meeting, on 12th February, the statement concluded.