48-Week Phase III Results Presented at Japanese Retina and Vitreous Society Meeting Show that Vabysmo Sustained Vision Improvements in Japanese Patients with Angioid Streaks

• The NIHONBASHI study, which demonstrated statistically significant and clinically meaningful vision improvement at 12 weeks for choroidal neovascularization associated with angioid streaks, presented 48-week extended results
• Visual acuity improvement demonstrated at 12 weeks is maintained at 48 weeks
• Vabysmo was generally well tolerated, and safety profile is consistent with the known profile of IVT therapies

TOKYO, December 8, 2025 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that 48-week data from the Phase III clinical trial (NIHONBASHI study) evaluating anti-VEGF/anti-Ang-2 humanized bispecific monoclonal antibody Vabysmo^® Intravitreal Injection 120 mg/mL [generic name: faricimab (genetical recombination)] (hereafter Vabysmo) in angioid streaks associated with neovascularization were presented at the 64th Annual Meeting of the Japanese Retina and Vitreous Society.

“We are very pleased that the 48-week data from the NIHONBASHI study in Japanese patients demonstrated sustained vision improvements and reduction in retinal edema. We will continue to deliver this value to patients and contribute to long-term preservation of vision through continuing to strengthen the data and provide information on the appropriate use of this treatment,” said Chugai’s President and CEO, Dr. Osamu Okuda.

Vabysmo is the first drug in Japan to be approved for choroidal neovascularization associated with angioid streaks. These results showed that the improvement in visual acuity and drying of exudate obtained by 12 weeks was maintained until 48 weeks. Retinal drying is an important clinical indicator, and edema caused by excess fluid in the retina is associated with visual distortion and foggy vision. In this study, the safety profile was consistent to that of previous studies.

The study evaluated the average change in best-corrected visual acuity (BCVA) score (the best vision a person can achieve – including with correction such as glasses – when reading letters on an eye chart) from baseline. The study also tracked the amount of swelling in the back of the eye due to retinal fluid, as measured by central subfield thickness (CST).

NIHONBASHI study result (at 48 weeks)

• The mean vision improvement effect from baseline in people receiving Vabysmo was +7.3 letters (90% confidence interval: 4.5 to 10.0 letters) at Week 48.
• The mean change in central subfield thickness from baseline was −104 µm (90% confidence interval: −123 to −85 µm) at Week 48.

[Reference]

Positive Phase III Results Showed Vabysmo Improved Vision for the First Time in Japanese in Angioid Streaks (Press release by Chugai issued on April 15, 2024)
https://www.chugai-pharm.co.jp/english/news/detail/20240415113000_1064.html

Chugai Files in Japan for Additional Indication of Vabysmo for Angioid Streaks, a Leading Cause of Vision Loss (Press release by Chugai issued on September 6, 2024)
https://www.chugai-pharm.co.jp/english/news/detail/20240906150000_1098.html

First Positive Phase III Results Presented at Japanese Ophthalmological Society Meeting Demonstrated that Vabysmo Sufficiently Improved Vision in Japanese Patients with Angioid Streaks (Press release by Chugai issued on April 17, 2025)
https://www.chugai-pharm.co.jp/english/news/detail/20250417122000_1150.html

About the NIHONBASHI study
The NIHONBASHI study is a multicenter, open-label, single-arm Phase III study in Japan evaluating the efficacy and safety of Vabysmo in people with angioid streaks associated with neovascularization. In this study, 24 patients with angioid streaks were enrolled and received Vabysmo every 4 weeks for the first three doses, followed by disease activity assessments at 4-week interval visits with Vabysmo administered as needed.

The primary endpoint of the study was change in best-corrected visual acuity (BCVA) from baseline at week 12. Secondary endpoints for weeks 0-12 of the study included change in central subfield thickness (CST) from baseline up to week 12. Secondary endpoints for weeks 12-48 of the study included change in BCVA and CST from baseline, and the proportion of individuals with resolution of intraretinal fluid (IRF) and subretinal fluid (SRF).

About angioid streaks
Angioid streaks is a disease characterized by cracks in parts of the retina, causing-discoloration (pigmented streak) of the fundus. The disease is often asymptomatic, and when choroidal neovascularization extends to the macula region of the fundus, it causes symptoms such as decreased or distorted vision. People with neovascularization have a poor prognosis, but conventional treatments such as surgery and laser are not sufficiently effective, and new treatment options are needed. The number of patients with angioid streaks in Japan is unknown, but approximately 300 patients have pseudoxanthoma elasticum (one of the designated intractable diseases), which is known to be associated with angioid streaks in approximately half of patients.^1,2

About Vabysmo
Vabysmo is the first bispecific antibody approved for the eye. ^3,4,5 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. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilize blood vessels. ^5,6 Vabysmo is approved in over 100 countries around the world, including the United States (US), Japan, the United Kingdom and the European Union, for people living with neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema, and in several countries, including the US, EU and Japan, for the treatment of macular edema following retinal vein occlusion. Review by other health authorities is ongoing. ^3,4,7,8

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

Sources

1. Chatziralli I, Saitakis G, Dimitriou E, Chatzirallis A, Stoungioti S, Theodossiadis G, et al. ANGIOID STREAKS: A Comprehensive Review From Pathophysiology to Treatment. Retina. 2019;39(1):1-11.
2. Japan Intractable Diseases Information Center. Pseudoxanthoma elasticum (designated intractable disease 166) [Internet; cited December 2025]. Available from: https://www.nanbyou.or.jp/. (Japanese only)
3. United States Food and Drug Administration (U.S. FDA). Highlights of prescribing information, Vabysmo. 2022 [Internet; cited December 2025]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761235s000lbl.pdf.
4. Medicines and Healthcare products Regulatory Agency approves faricimab through international work-sharing initiative. [Internet; cited December 2025]. Available from: https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative.
5. Heier JS, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for nAMD (TENAYA and LUCERNE): two randomised, double-masked, Phase III, non-inferiority trials. The Lancet. 2022; 399:729-40.
6. Wykoff C, et al. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with DME (YOSEMITE and RHINE): two randomised, double-masked, Phase III trials. The Lancet. 2022; 399:741-755.
7. European Medicines Agency. Summary of product characteristics, Vabysmo. 2024. [Internet; cited December 2025]. Available from: https://www.ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf.
8. Roche data on file.