SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--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.

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% (n=151/286) of faricimab treat-and-extend patients in YOSEMITE and 51% (n=157/308) in RHINE achieved four-month dosing at one year. An additional 21% (n=60/286) of faricimab treat-and-extend patients in YOSEMITE and 20% (n=62/308) in RHINE achieved three-month dosing. Combined, more than 70% 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 intraretinal fluid through the first year consistently favored faricimab over aflibercept. Faricimab was generally well-tolerated in both studies, with a favorable benefit-risk profile. Ocular AEs were comparable across treatment arms and consistent with those expected with intravitreal anti-VEGF injections in patients with DME.

Faricimab is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of wet AMD and DME. The European Medicines Agency is also currently evaluating the faricimab Marketing Authorization Application for the treatment of wet AMD 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.

Two-year results for faricimab in DME will be presented at the Angiogenesis, Exudation, and Degeneration 2022 meeting, on Saturday, February 12.

About the TENAYA and LUCERNE Studies

TENAYA (NCT03823287) and LUCERNE (NCT03823300) are two identical, randomized, multicenter, double-masked, global Phase III studies evaluating the efficacy and safety of faricimab compared to aflibercept in 1,329 people living with wet age-related macular degeneration (671 in TENAYA and 658 in LUCERNE). The studies each have two treatment arms: faricimab 6.0 mg administered at fixed intervals of two, three, or four months, following four initial monthly doses, selected based on objective assessment of disease activity at weeks 20 and 24; and aflibercept 2.0 mg administered at fixed two-month intervals. In both arms, sham injections were administered at study visits when treatment injections were not scheduled, to maintain the masking of investigators and participants.

The primary endpoint of the studies is the average change in best-corrected visual acuity (BCVA) score (the best distance vision a person can achieve – including with correction such as glasses – when reading letters on an eye chart) from baseline, averaged over weeks 40, 44 and 48. Secondary endpoints include: safety; the percentage of participants in the faricimab arm receiving treatment every two, three and four months; the percentage of participants achieving a gain, and the percentage avoiding a loss, of 15 letters or more in BCVA from baseline over time; change in central subfield thickness from baseline over time; and change in total area of choroidal neovascularization lesion and leakage from baseline over time.

About the YOSEMITE and RHINE Studies

YOSEMITE (NCT03622580) and RHINE (NCT03622593) are two identical, randomized, multicenter, double-masked, global Phase III studies evaluating the efficacy and safety of faricimab compared to aflibercept in 1,891 people with diabetic macular edema (940 in YOSEMITE and 951 in RHINE). The studies each have three treatment arms: faricimab 6.0 mg administered up to every four months using a treat-and-extend approach after four initial monthly doses; faricimab 6.0 mg administered at fixed two-month intervals after six initial monthly doses; and aflibercept administered at fixed two-month intervals after five initial monthly doses. In all three arms, sham injections were administered at study visits when treatment injections were not scheduled, to maintain the masking of investigators and participants.

The primary endpoint of the studies is the average change in best-corrected visual acuity (BCVA) score from baseline at one year, averaged over weeks 48, 52 and 56. Secondary endpoints included: safety; the percentage of participants in the treat-and-extend arm receiving faricimab every one, two, three and four months, at week 52; the percentage of participants achieving a two-step or greater improvement from baseline in diabetic retinopathy severity at week 52; the percentage of participants achieving a gain, and the percentage avoiding a loss, of 15 letters or more in BCVA from baseline over time; change in central subfield thickness from baseline over time; and percentage of patients with absence of intraretinal fluid over time.

About Wet Age-Related Macular Degeneration

Age-related macular degeneration (AMD) is a condition that affects the macula, the part of the eye that provides sharp, central vision needed for activities like reading. It is a leading cause of blindness for people aged 60 and over in the United States. Wet, or neovascular, AMD is an advanced form of the disease that can cause rapid and severe vision loss if left untreated. Approximately 11 million people in the United States have some form of AMD, and of those, about 1.1 million have wet AMD.

Wet AMD is caused by growth of abnormal blood vessels, also referred to as choroidal neovascularization (CNV), into the macula. These vessels leak fluid and blood and cause scar tissue that destroys the central retina. This process results in a deterioration of sight over a period of months to years.

About Diabetic Macular Edema

Affecting approximately 750,000 people in the United States, diabetic macular edema (DME) is a vision-threatening retinal condition associated with blindness and decreased quality of life when left untreated. DME occurs when damaged blood vessels in the retina leak into and cause swelling in the macula – the central area of the retina responsible for the sharp vision needed for reading and driving. The number of people with DME is expected to grow as the prevalence of diabetes increases.

About Faricimab

Faricimab is the first investigational bispecific antibody designed for the eye. It targets and inhibits 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). Ang-2 and VEGF-A contribute to vision loss by destabilizing blood vessels, causing new leaky blood vessels to form and increasing inflammation. By blocking both pathways involving Ang-2 and VEGF-A, faricimab is designed to stabilize blood vessels.

About Genentech in Ophthalmology

Genentech is researching and developing new treatments for people living with a range of eye diseases that cause significant visual impairment and blindness, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR), geographic atrophy (GA) and other retinal conditions.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

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