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The Lancet Publishes Studies Showing Genentech’s Faricimab Improved and Maintained Vision in Two Leading Causes of Vision Loss, Extending Time Between Treatments up to Four Months

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced The Lancet has published two papers highlighting one-year results from four pivotal Phase III studies of faricimab, an investigational bispecific antibody, in wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). All four studies – which enrolled more than 3,000 people in total – met their primary endpoints, showing that patients 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 wet AMD studies and the YOSEMITE and RHINE DME studies. The current standard of care for these potentially blinding conditions requires eye injections as often as once a month.

“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., chief medical officer and head of Global Product Development. “We remain deeply committed to developing new medicines such as faricimab that may help preserve sight in many people living with serious retinal conditions.”

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 neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Inhibition of both pathways has been shown to have complementary benefits, stabilizing vessels and thereby reducing vessel leakage and inflammation more than inhibition of the VEGF-A pathway alone.

Key Findings

In the TENAYA and LUCERNE studies in wet AMD, 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% (n=144/315) of patients in TENAYA and 45% (n=142/316) in LUCERNE were able to be treated every four months in the first year. An additional 34% (n=107/315) of patients in TENAYA and 33% (n=104/316) in LUCERNE were able to be treated every three months. Combined, nearly 80% 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 neovascularization lesion size and area. Faricimab was generally well-tolerated in both studies, with a favorable benefit-risk profile. Ocular adverse events (AEs) were comparable across treatment arms and consistent with those expected with intravitreal anti-VEGF injections in patients with wet AMD.

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The Lancet Publishes Studies Showing Genentech’s Faricimab Improved and Maintained Vision in Two Leading Causes of Vision Loss, Extending Time Between Treatments up to Four Months Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced The Lancet has published two papers highlighting one-year results from four pivotal Phase III studies of faricimab, an investigational bispecific antibody, in wet, …

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