Vabysmo (faricimab-svoa) / Roche, Xoma - LARVOL DELTA

Effect of Faricimab versus Aflibercept on Hyperreflective Foci in Patients with Diabetic Macular Edema from the YOSEMITE/RHINE Trials. (PubMed, Ophthalmol Sci) - P3 | "Greater HRF reductions were achieved with faricimab versus aflibercept, supporting the therapeutic potential of dual Ang-2/VEGF-A inhibition to suppress disease activity in DME. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article."

Journal • Diabetic Macular Edema • Ophthalmology

Intraocular Inflammation Following Faricimab Intravitreal Injection Treated With Sub-tenon Triamcinolone Acetonide Injection. (PubMed, Cureus) - "In this study, IOI was managed with a STTA injection during the early stage of uveitis. Severe inflammation can lead to complications such as posterior iris synechia."

Journal • Age-related Macular Degeneration • Diabetic Macular Edema • Inflammation • Macular Degeneration • Ocular Inflammation • Ophthalmology • Retinal Disorders • Uveitis

Anti-VEGFs for Diabetic Macular Oedema: Analysis of Efficacy, Safety, and Cost of More Durable Therapies from a Dutch Societal Perspective. (PubMed, Adv Ther) - "Despite similar efficacy and safety, differences in treatment burden were identified among the anti-VEGFs, with the more durable regimen of aflibercept 8 mg potentially reducing overall injection frequency compared to current care. Nevertheless, on the basis of current list prices, bevacizumab is the least expensive anti-VEGF for treating DMO. Aflibercept 8 mg, aflibercept 2 mg, faricimab, and ranibizumab could achieve cost-equivalence to bevacizumab if their medication prices were reduced by at least 23%, 74%, 63%, and 71%. These results could support future decision-making of healthcare providers and payers, encompassing aspects of medical costs, healthcare capacity use, and burden on patients as well as the healthcare system as a whole."

Journal • Diabetic Macular Edema • Macular Edema • Ophthalmology

Identification of OCT-based imaging biomarkers for predicting treatment response of refractory diabetic macular edema to faricimab and dexamethasone implant. A real-world prospective study (ChiCTR) - P=N/A | N=80 | Not yet recruiting | Sponsor: Chinese University of Hong Kong; Department of Ophthalmology and Visual Sciences (DOVS), The Chinese University of Hong Kong

Biomarker • New trial • Real-world evidence • Diabetic Macular Edema • Ophthalmology

FAN: Faricimab for High-frequent Aflibercept Treated Neovascular Age-related Macular Degeneration (clinicaltrials.gov) - P4 | N=70 | Completed | Sponsor: Medical University of Graz | Active, not recruiting ➔ Completed | Trial completion date: Jun 2025 ➔ Feb 2025 | Trial primary completion date: Mar 2025 ➔ Sep 2024

Trial completion • Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Retinal Vasculitis after Intravitreal Faricimab Injection. (PubMed, Ophthalmol Retina) - No abstract available

Journal • Ocular Inflammation • Vasculitis

Early Anatomical and Functional Outcomes of Faricimab in Recalcitrant Neovascular Age-Related Macular Degeneration: A Retrospective Real-World Study in an East-Asian Population. (PubMed, Ophthalmol Ther) - "Intravitreal faricimab demonstrated improved anatomical outcomes with stable visual acuity and extended treatment intervals in patients with recalcitrant nAMD in Taiwan, addressing a key evidence gap. Future studies with longer follow-ups are needed to validate these findings."

Journal • Real-world evidence • Retrospective data • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Association between intravitreal anti-vascular endothelial growth factor agents and hypertension: a meta-analysis. (PubMed, Can J Ophthalmol) - "This meta-analysis found no significant difference in hypertension risk between different intravitreal anti-VEGF agents or sham injection. These results reinforce the notion that these agents have similar and safe side effect profiles, and that the choice of agent should not be based on the risk of hypertension."

Clinical • Journal • Retrospective data • Cardiovascular • Hypertension

Real-Life Treatment Intervals and Morphological Outcomes Following the Switch to Faricimab Therapy in Neovascular Age-Related Macular Degeneration. (PubMed, J Pers Med) - " This retrospective study included the eyes of patients diagnosed with nAMD who had been switched to faricimab treatment due to the persistence of intraretinal fluid (IRF) and/or subretinal fluid (SRF), despite monthly anti-VEGF treatment with aflibercept, bevacizumab, or ranibizumab using the treat and extend regimen, and who had received at least three faricimab injections following the switch. No adverse events were reported throughout the entire treatment period. In nAMD patients with poor anti-VEGF treatment response, complete and fast fluid resolution and the extension of treatment intervals can be reached by switching to faricimab, even after years of prior unsuccessful therapy."

Journal • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Study to Evaluate the Efficacy and Safety of IBI302 inSubjects With Diabetic Macular Edema（DME） (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center) | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetic Macular Edema • Macular Edema • Ophthalmology

Effectiveness and safety of anti-VEGF therapies for macular edema in retinal vein occlusion: A systematic review and meta-analysis of randomized controlled trials. (PubMed, Surv Ophthalmol) - "Subgroup analysis highlighted faricimab as most effective, with aflibercept, ranibizumab, and bevacizumab providing substantial benefits. Anti-VEGF therapy is an effective, safe cornerstone for managing ME in RVO. Further research should explore biomarkers and combination treatments to refine therapeutic approaches."

Journal • Retrospective data • Review • Cardiovascular • Macular Edema • Ophthalmology • Retinal Vein Occlusion

Successful Response to Intravitreal Faricimab Injections in a Case of Neovascular Age-Related Macular Degeneration in Vitrectomized Eyes. (PubMed, Cureus) - "We report a case of nAMD in a vitrectomized eye that showed inadequate response to both aflibercept and brolucizumab, but experienced effective suppression of exudation following intravitreal administration of faricimab. This case suggests that faricimab may offer a therapeutic benefit in managing exudative changes in vitrectomized eyes with nAMD."

Journal • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

[Ad hoc announcement pursuant to Art. 53 LR] Roche continues good momentum into 2025 with 6% (CER) sales growth in the first quarter (Roche Press Release) - "Strong demand for both pharmaceutical products and diagnostic solutions more than made up for the impact from the loss of exclusivity on Avastin (various types of cancer), Herceptin (breast and gastric cancer), MabThera/Rituxan (blood cancer, rheumatoid arthritis), Esbriet (lung disease), Lucentis (severe eye diseases) and Actemra/RoActemra (rheumatoid arthritis, COVID-19), totalling CHF 0.2 billion, and the impact of the recent healthcare pricing reforms in China...The top five growth drivers – Phesgo, Vabysmo, Xolair, Hemlibra and Xofluza (influenza) – achieved total sales of CHF 3.6 billion; Sales in Europe grew by 5% as the strong uptake of Vabysmo, Polivy, Ocrevus, Phesgo and Hemlibra; In Japan, sales increased by 3% due to growth in sales of Phesgo, Vabysmo...Diagnostics: key developments - Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU"

Commercial • Ankylosing Spondylitis • Asthma • HER2 Breast Cancer • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Ophthalmology • Ovarian Cancer • Pruritus • Schizophrenia

Twelve-Month Outcomes of Faricimab for Patients with Sub-Optimally Responsive Diabetic Macular Oedema: A Retrospective Single-Centre Study. (PubMed, Clin Ophthalmol) - "The mean injection interval increased to 9.2 (±3.2) weeks (p < 0.001), and a mean of 7.92 (±2.53) faricimab injections was administered. DMO patients with sub-optimal response to aflibercept 2mg experienced improved anatomical outcomes and extended treatment intervals while maintaining vision on faricimab, with no new safety concerns."

Journal • Retrospective data • Diabetic Macular Edema • Diabetic Retinopathy • Macular Edema • Ophthalmology • Retinal Disorders

Faricimab in previously treated neovascular age-related macular degeneration : Study design of the prospective noninterventional study PASSENGER (PubMed, Ophthalmologie) - "Data from the PASSENGER study are intended to contribute to a better understanding of therapy management in daily practice in Germany."

Journal • Observational data • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Macular Edema • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Impact of Capacity and Resource Constraints on Wet Age-Related Macular Degeneration and Diabetic Macular Edema in the Brazilian Public Healthcare System: an Individual-Level Microsimulation Study (ISPOR 2025) - "Faricimab, with longer injection intervals, significantly reduces hospital visits and treatment delays for wAMD and DME compared with aflibercept 2 mg, ranibizumab, and bevacizumab in the Brazilian Public Healthcare System. This reduction eases the burden on SUS, enhancing the system’s efficiency and patient care."

Clinical • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

The Real-World Cost-Effectiveness of Faricimab Versus Existing and Future Biosimilars in Patients with Neovascular Age-Related Macular Degeneration in the UK (ISPOR 2025) - "The results demonstrate that faricimab is cost-effective versus both aflibercept 2mg and ranibizumab biosimilars reflecting likely NHS drug prices. Furthermore, the results indicate that drug acquisition costs are an increasingly small part of the overall cost of care. The results reinforce the need to consider costs beyond drug acquisition costs in payer decision-making."

Clinical • Cost effectiveness • HEOR • Real-world • Real-world evidence • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

The Real-World Cost-Effectiveness of Faricimab Versus Existing and Future Biosimilars in Patients with Neovascular Age-Related Macular Degeneration in Canada (ISPOR 2025) - "The results demonstrate that faricimab is cost-effective versus both aflibercept 2mg and ranibizumab biosimilars reflecting likely local drug prices. Furthermore, the results indicate that drug acquisition costs are an increasingly small part of the overall cost of care. The results reinforce the need to consider costs beyond drug acquisition costs in payer decision-making."

Clinical • Cost effectiveness • HEOR • Real-world • Real-world evidence • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Cost-Utility Analysis of Faricimab Versus Aflibercept in Treating Neovascular Age-Related Macular Degeneration (nAMD) in the United States (ISPOR 2025) - "Faricimab offers superior economic value over aflibercept for nAMD treatment in the U.S., achieving comparable or improved clinical outcomes with fewer injections and lower costs. These findings support the adoption of faricimab as a cost-effective treatment option, potentially influencing future clinical guidelines and healthcare policies to optimize resource allocation while enhancing patient outcomes."

HEOR • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Population Impact Model of Faricimab and Aflibercept 8mg among US patients with Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration (ISPOR 2025) - "Compared to aflibercept 8mg, faricimab generated significant cost savings driven by injection frequency and lower drug costs, demonstrating its economic advantage considering varying prevalence rates by state."

Clinical • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Chugai Obtains First Regulatory Approval in Japan for Vabysmo for Additional Indication of Angioid Streaks, a Cause of Vision Loss (Chugai Press Release) - "Chugai Pharmaceutical Co., Ltd...announced today that it obtained regulatory approval from 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 an additional indication of the treatment of choroidal neovascularization associated with angioid streaks. Vabysmo is the first approved drug in Japan for the treatment of this disease....This approval is based on the results from a Japanese phase III NIHONBASHI study for angioid streaks."

Japan approval • Ophthalmology • Retinal Disorders

Short-term real-world outcomes of diabetic macular edema treated with intravitreal faricimab. (PubMed, PLoS One) - "In contrast, the central macular thickness improved for both the naïve and switched groups. IVF demonstrated good short-term outcomes for DME, suggesting that it is effective for DME in clinical practice."

Journal • Real-world evidence • Retrospective data • Diabetic Macular Edema • Ophthalmology

Roche to Invest USD276 Million to Build Its Second Drug Plant in Shanghai (Yicai Global) - "Switzerland's Roche plans to invest CNY2 billion (USD276.4 million) to build its second Chinese biopharmaceutical production base in Shanghai, expanding its local innovative drug capacity. The facility, located in the Zhangjiang Hi-Tech Park in Shanghai's Pudong New Area like Roche's first one, will produce Vabysmo eye injection once it becomes operational in 2031, the Basel-based firm announced on WeChat yesterday. Construction is expected to be completed in 2029. Vabysmo (faricimab-svoa) is a prescription medicine given by injection into the eye to treat adults with neovascular (wet) age-related macular degeneration, diabetic macular edema, and macular edema following retinal vein occlusion."

Commercial • Diabetic Macular Edema • Macular Degeneration • Macular Edema • Ophthalmology • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Early Outcomes After Initiation of Faricimab in Patients With Diabetic Macular Edema. (PubMed, Ophthalmic Surg Lasers Imaging Retina) - "In patients with DME receiving faricimab, visual acuity was maintained in previously treated and improved in treatment-naïve eyes. Both groups had anatomical improvement. [Ophthalmic Surg Lasers Imaging Retina 2025;56:XX-XX.]."

Journal • Diabetic Macular Edema • Ophthalmology

Faricimab Reverts VEGF-A165-Induced Impairment of the Barrier Formed by Retinal Endothelial Cells. (PubMed, Int J Mol Sci) - "Secretion of Ang-2 by iBREC was significantly higher after exposure to VEGF-A165, and strongly reduced by faricimab even below basal levels; aflibercept was significantly less efficient. Taken together, faricimab sustainably reverts VEGF-A165-induced barrier impairment and protects against detrimental actions of Ang-2 by lowering its secretion."

Journal • CLDN1 • CLDN5 • VEGFA