• The application was submitted based on a global phase III clinical study, BALATON study for branch retinal vein occlusion, and COMINO study for central retinal or hemiretinal vein occlusion

TOKYO, April 27, 2023 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it filed for additional application with the Ministry of Health, Labour and Welfare (MHLW) for anti-VEGF/anti-Ang-2 bispecific antibody Vabysmo^® Intravitreal Injection 120 mg/mL [generic name: faricimab (genetical recombination)], for the treatment of macular edema associated with retinal vein occlusion (RVO) today.

“I’m very pleased that we have filed an additional indication for Vabysmo, the first bispecific antibody in the ophthalmology field for macular edema associated with RVO,” said Chugai’s President and CEO, Dr. Osamu Okuda. “RVO is a disease that can threaten vision and lead to blindness. In addition to existing indications, we will seek approval as soon as possible so that Vabysmo can further contribute to treating patients as a new treatment option for macular edema associated with RVO.”

This application is based on the results of the BALATON and COMINO studies for branch retinal vein occlusion and central retinal or hemiretinal vein occlusion, respectively. Both are global phase III clinical studies, and Chugai participated in both studies from Japan.

[Reference]

・BALATON and COMINO studies
New phase III data show Roche’s Vabysmo rapidly improved vision and reduced retinal fluid in people with retinal vein occlusion (RVO) (Press release by Roche issued on February 10, 2023)
https://www.roche.com/media/releases/med-cor-2023-02-10

About Vabysmo

Vabysmo is the first bispecific antibody approved for the eye.^1,2 It targets and inhibits two signaling 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.^3,4 By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilize blood vessels.^3,4 Vabysmo is approved in more than 50 countries around the world, including the United States, Japan, the United Kingdom, and the European Union, for people living with neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema. Review by other regulatory authorities is ongoing.^1,2,5-7

About retinal vein occlusion (RVO)

RVO is the second most common cause of vision loss due to retinal vascular diseases.⁸ It affects an estimated 28 million adults globally, mainly those aged 60 or older, and can lead to severe and sudden vision loss.^8,9 RVO typically results in sudden, painless vision loss in the affected eye because the vein blockage restricts normal blood flow in the affected retina, resulting in ischemia, bleeding, fluid leakage, and retinal swelling called macular edema.^8-10 Currently, macular edema due to RVO is typically treated with repeated intravitreal injections of anti-vascular endothelial growth factor therapies.¹¹ There are two main types of RVO: branch retinal vein occlusion, which affects more than 23 million people globally and occurs when one of the four smaller ‘branches’ of the main central retinal vein becomes blocked; and central retinal vein occlusion, which is less common, affecting more than four million people worldwide, and occurs when the eye’s central retinal vein becomes blocked.^8,11

Trademarks used or mentioned in this release are protected by law.

Sources

1. United States Food and Drug Administration (U.S. FDA). Highlights of prescribing information, Vabysmo. 2022 [Internet; cited April 2023]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761235s000lbl.pdf.
2. Medicines and Healthcare products Regulatory Agency (MHRA). MHRA approves faricimab through international work-sharing initiative [Internet; cited April 2023]. Available from: https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative.
3. Heier JS, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (nAMD) (TENAYA and LUCERNE): two randomised, double-masked, phase III, non-inferiority trials. The Lancet. 2022; 399:729-740.
4. Wykoff C, et al. Efficacy, durability and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular edema (DME) (YOSEMITE and RHINE): two randomised, double-masked, phase III trials. The Lancet. 2022; 399:741-755.
5. European Medicines Agency. Summary of Product Characteristics, Vabysmo, 2022 [Internet; cited April 2023]. Available from: https://www.ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf.
6. Roche data on file.
7. Chugai Pharmaceutical Co. Ltd. Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, for nAMD and DME [Internet; cited April 2023]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html.
8. Song P, et al. Global epidemiology of retinal vein occlusion (RVO): a systematic review and meta-analysis of prevalence, incidence and risk factors. J Glob Health. 2019;9:010427.
9. Moorfields Eye Hospital, United Kingdom National Health Service Foundation Trust. RVO [Internet; cited April 2023]. Available from: https://www.moorfields.nhs.uk/condition/retinal-vein-occlusion.
10. Schmidt-Erfurth U, et al. Guidelines for the Management of Retinal Vein Occlusion by the European Society of Retina Specialists (EURETINA). Ophthalmologica. 2019;242:123-162.
11. Campochiaro P. Molecular pathogenesis of retinal and choroidal vascular diseases. Prog Retin Eye Res. 2015;49:67-81.