In the TENAYA and LUCERNE studies, more than 60% of Vabysmo patients could be treated every four months at two years. This represents an increase from 45% at year one

Patients treated with Vabysmo received a median number of 10 injections over the two years versus 15 injections for those treated with aflibercept, potentially decreasing the number of injections

No new safety signals were identified and Vabysmo continued to be well tolerated, with a favourable benefit-risk profile

Basel, 14 July 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new two-year data from the TENAYA and LUCERNE studies that reinforce the long-term efficacy, safety and durability of Vabysmo® (faricimab) in neovascular or “wet” age-related macular degeneration (nAMD), a leading cause of vision loss. 1,2 Neovascular AMD affects nearly 20 million people globally and can require treatment with eye injections every one to two months. 2,3,4 The two-year data were presented at the 2022 American Society of Retina Specialists Annual Scientific Meeting on 14 July.

“These longer-term results reinforce confidence in Vabysmo and support its continued use in people with neovascular AMD,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “With the potential to require fewer injections over time, Vabysmo continues to represent an important step forward for people with vision-threatening retinal conditions, and these data exemplify our commitment to redefining standards of care and reducing treatment burden.”

In the TENAYA and LUCERNE studies, at two years:

More than 60% of people receiving Vabysmo could be treated every four months – an increase of over 15 percentage points since the primary analysis at one year – while achieving comparable vision gains versus aflibercept given every two months.

Nearly 80% of people receiving Vabysmo could be treated every three months or longer.

Patients treated with Vabysmo received a median number of 10 injections over the two years versus 15 injections for those patients treated with aflibercept, potentially decreasing the number of injections.

Comparable reductions in central subfield thickness (CST) were observed with Vabysmo given at intervals of up to four months versus aflibercept given every two months.

No new safety signals were identified and Vabysmo continued to be well tolerated, with a favourable benefit-risk profile.

The primary analyses at one year formed the basis of the recent nAMD approvals in the US, Japan, the UK and several other countries around the world. Vabysmo is also approved in these countries for diabetic macular edema (DME). Vabysmo is currently under review by the European Medicines Agency for these conditions, and submissions to other regulatory authorities around the world are ongoing.

Vabysmo is the first bispecific antibody for the eye and the only injectable eye medicine approved in a number of countries for treatments up to four months apart. 4,5 Vabysmo is designed to block two disease pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). 4 While research is underway to better understand the role of the Ang-2 pathway in retinal disease, Ang-2 and VEGF-A are thought to contribute to vision loss by destabilising blood vessels, which may cause new leaky blood vessels to form and increase inflammation.

Detailed Two-Year Results

In the TENAYA and LUCERNE studies, nAMD patients received Vabysmo given at intervals of two, three or four months or aflibercept given every two months. In the second year, the dosing schedule for Vabysmo patients could be adjusted based on their response to treatment.

At two years, vision improvements were comparable across both treatment arms. In TENAYA, the average vision gains from baseline at two years were +3.7 eye chart letters in the Vabysmo arm and +3.3 letters in the aflibercept arm. In LUCERNE, the average vision gains from baseline at two years were +5.0 letters in the Vabysmo arm and +5.2 letters in the aflibercept arm.

Furthermore, 59% (n=160/271) of Vabysmo patients in TENAYA and 67% (n=192/287) in LUCERNE achieved four-month dosing at two years. This is an increase over one-year results, which showed 46% (n=144/315) of Vabysmo patients in TENAYA and 45% (n=142/316) in LUCERNE achieved four-month dosing. An additional 15% (n=41/271) of Vabysmo patients in TENAYA and 14% (n=41/287) in LUCERNE achieved three-month dosing at two years. Combined, more than 78% of Vabysmo patients were able to go three months or longer between treatments at the end of the second year.

In both studies, comparable reductions in CST were observed with Vabysmo given at intervals of up to four months versus aflibercept given every two months. Safety results were consistent across study arms, with no reported cases of retinal vasculitis or intraocular inflammation (IOI) associated with retinal vein or retinal artery occlusion.

Roche has a robust phase III clinical development programme for Vabysmo. The programme includes AVONELLE-X, an extension study of TENAYA and LUCERNE evaluating the long-term safety and tolerability of Vabysmo in nAMD, and RHONE-X, an extension study of YOSEMITE and RHINE evaluating the long-term safety and tolerability of Vabysmo in DME. 6,7 Additionally, the COMINO and BALATON trials are also underway, evaluating the efficacy and safety of Vabysmo in people with macular edema following retinal vein occlusion. 8,9 Roche has also initiated the phase IV Elevatum study of Vabysmo in underrepresented patient populations with DME.

About the TENAYA and LUCERNE studies

TENAYA (NCT03823287) and LUCERNE (NCT03823300) are two identical, randomised, multicentre, double-masked, global phase III studies evaluating the efficacy and safety of Vabysmo compared to aflibercept in 1,329 people living with nAMD (671 in TENAYA and 658 in LUCERNE). The studies each have two treatment arms: Vabysmo 6 mg administered at intervals of two, three, or four months, following four initial monthly doses, selected based on objective assessment of disease activity as measured by optical coherence tomography and visual acuity evaluations at weeks 20 and 24; and aflibercept 2 mg administered at fixed two-month intervals after three initial monthly doses. At week 60, patients randomised to the Vabysmo arm were treated using a treat-and-extend approach up to week 108. Dosing schedule for Vabysmo patients during the treat-and-extend phase was adjusted based on treatment response as determined by central subfield thickness (CST) and visual acuity. 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 Vabysmo 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; and change in CST from baseline over time.

About neovascular age-related macular degeneration

Age-related macular degeneration (AMD) is a condition that affects the part of the eye that provides sharp, central vision needed for activities like reading. 2,11 Neovascular or “wet” AMD (nAMD) is an advanced form of the disease that can cause rapid and severe vision loss if left untreated. 12,13 It develops when new and abnormal blood vessels grow uncontrolled under the macula, causing swelling, bleeding and/or fibrosis. 13 Worldwide, around 20 million people are living with nAMD – the leading cause of vision loss in people over the age of 60 – and the condition will affect even more people around the world as the global population ages.

About Vabysmo® (faricimab)

Vabysmo is the first bispecific antibody approved for the eye. It targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood vessels.

About Roche in ophthalmology

Roche is focused on saving people’s eyesight from the leading causes of vision loss through pioneering therapies. Through our innovation in the scientific discovery of new potential drug targets, personalised healthcare, molecular engineering, biomarkers and continuous drug delivery, we strive to design the right therapies for the right patients.

We have the broadest retina pipeline in ophthalmology, which is led by science and informed by insights from people with eye diseases. Our pipeline includes gene therapies and treatments for geographic atrophy and other vision-threatening diseases, including rare and inherited conditions.

Applying our extensive experience, we have already brought breakthrough ophthalmic treatments to people living with vision loss. Susvimo™ (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant is the first U.S. Food and Drug Administration-approved refillable eye implant for neovascular or “wet” age-related macular degeneration that continuously delivers a customised formulation of ranibizumab over a period of months. 15 Vabysmo® (faricimab) is the first bispecific antibody approved for the eye, which targets two disease pathways that drive retinal conditions. 5 Lucentis®️* (ranibizumab injection) is the first treatment approved to improve vision in people with certain retinal conditions.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan