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

[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) - "In the first three months of 2025, Roche achieved sales growth of 6% (7% in CHF) to CHF 15.4 billion...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. This represents a plus of CHF 0.7 billion at CER compared to the first quarter of 2024...Sales in Europe grew by 5% as the strong uptake of Vabysmo, Polivy, Ocrevus, Phesgo and Hemlibra more than compensated for the decline in sales of medicines with expired patents and..."

Commercial • Ankylosing Spondylitis • Asthma • Breast Cancer • Chronic Obstructive Pulmonary Disease • Immunology • Non-Hodgkin’s Lymphoma • Ophthalmology • Ovarian Cancer • Pruritus • Schizophrenia • Solid Tumor

Early Outcomes of Faricimab Treatment for Diabetic Macular Edema in Patients Previously Treated With Anti-VEGF Therapy. (PubMed, Ophthalmic Surg Lasers Imaging Retina) - "Faricimab appears to be a viable option for some DME patients who require a change in anti-VEGF therapy. [Ophthalmic Surg Lasers Imaging Retina 2025;56:XX-XX.]."

Journal • Diabetic Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis

Impact of Intravitreal Faricimab on Renal Function in Diabetic Patients (clinicaltrials.gov) - P=N/A | N=60 | Recruiting | Sponsor: University Hospital, Alexandroupolis | Active, not recruiting ➔ Recruiting

Enrollment open • Age-related Macular Degeneration • Diabetes • Diabetic Macular Edema • Macular Degeneration • Metabolic Disorders • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Impact of Intravitreal Faricimab on Renal Function in Diabetic Patients (clinicaltrials.gov) - P=N/A | N=60 | Active, not recruiting | Sponsor: University Hospital, Alexandroupolis

New trial • Age-related Macular Degeneration • Diabetes • Diabetic Macular Edema • Macular Degeneration • Metabolic Disorders • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Comparative efficacy of intravitreal anti-VEGF therapy for neovascular age-related macular degeneration: A systematic review with network meta-analysis. (PubMed, Acta Ophthalmol) - "The reference for comparison was monthly ranibizumab...For CRT, small but statistically significant improvements over the reference were observed for brolucizumab 3 mg (-27.9 μm) or 6 mg (-38.1 μm) in loading dose (LD) then every 8-12 weeks, aflibercept 8 mg in LD then every 12 (-26.9 μm) or 16 weeks (-32.1 μm), faricimab 6 mg in LD then treat-and-extend (-18.1 μm) and aflibercept 2 mg in LD then every 8 weeks (-11.3 μm)...When results are considered simultaneously, faricimab 6.0 mg or aflibercept 8.0 mg in a treatment regimen with an LD followed by either a treat-and-extend regimen or a fixed 12- or 16-week regimen appears to provide the optimal balance between visual outcomes, anatomical outcomes and the lowest treatment burden. However, studies of the long-term efficacy of newer anti-VEGF drugs are warranted."

Journal • Retrospective data • Review • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Real-World Evidence for Faricimab in Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema: A Scoping Review. (PubMed, Ophthalmol Sci) - "Further high-quality studies using prospective, multicenter designs are required to provide a more comprehensive understanding of the long-term outcomes associated with faricimab. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article."

HEOR • Journal • Real-world evidence • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

First Positive Phase III Results Presented at Japanese Ophthalmological Society Meeting Demonstrated that Vabysmo Sufficiently Improved Vision in Japanese Patients with Angioid Streaks (Chugai Press Release) - P3 | N=24 | NIHONBASHI | "In this study, the primary endpoint of mean change in best-corrected visual acuity from baseline at week 12 was +5.8 letters (90% confidence interval: 3.0 to 8.5 letters), with the lower limit of the 90% confidence interval exceeding the pre-specified clinically meaningful threshold of 0 letters, demonstrating statistically significant visual acuity improvement. Retinal fluid, which can be caused by vascular leakage, may lead to retinal edema and blurred vision. For one of the secondary endpoints, the mean change in central retinal thickness from baseline at week 12 was -106.4 µm (90% confidence interval: -123.4 to -89.4). Vabysmo was generally well tolerated. The safety profile was consistent with the known profile, and no new safety concerns were identified."

P3 data • Ophthalmology • Retinal Disorders

Intravitreal injection of faricimab to treat macular and retinovascular diseases in Nigerians: Early real-world experience. (PubMed, J Fr Ophtalmol) - "IVF was safe and effective for treating nAMD, DME and other retinovascular diseases in Nigerians in this pilot study. Outcomes of large sample size studies are expected."

Journal • Real-world evidence • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Safety profile of faricimab: a multi-source pharmacovigilance analysis using FAERS and JADER. (PubMed, BMC Pharmacol Toxicol) - "This study identified previously unreported safety signals, suggesting the need for potential updates to faricimab's safety labeling. Faricimab's dual-target mechanism presents unique safety concerns. Clinicians should monitor ocular inflammation and vascular complications, particularly in younger males and Asian patients. Further studies using real-world data are needed to validate these findings."

Adverse events • Journal • Cardiovascular • Cataract • Hematological Disorders • Inflammation • Ocular Inflammation • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Uveitis • Vasculitis

Switching to Faricimab in Therapy-Resistant Macular Edema Due to Retinal Vein Occlusion: Initial Real-World Efficacy Outcomes. (PubMed, J Clin Med) - " This retrospective study included patients from LMU University Hospital who were switched to Faricimab due to an inadequate response or adverse events related to prior intravitreal therapy (Ranibizumab, Aflibercept, or OzurdexTM). Given the small sample size and retrospective design, these findings should be interpreted as exploratory and hypothesis-generating. Further studies are needed to evaluate long-term efficacy and optimal treatment regimens."

Journal • Real-world evidence • Macular Edema • Ophthalmology • Retinal Vein Occlusion

Deep learning assisted analysis of biomarker changes in refractory neovascular AMD after switch to faricimab. (PubMed, Int J Retina Vitreous) - "This study highlights the potential of AI-driven biomarker segmentation as a precise and scalable tool for monitoring disease progression in treatment-resistant nAMD. By enabling objective and reproducible analysis of OCT biomarkers, deep learning algorithms provide critical insights into treatment response. Faricimab demonstrated significant and sustained anatomical improvements, allowing for extended treatment intervals while maintaining disease stability. Future research should focus on refining AI models to improve predictive accuracy and assessing long-term outcomes to further optimize disease management."

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

Efficacy of Aflibercept (8 mg) for Diabetic Macular Edema in Vitrectomized Eyes Refractory to the Other Anti-VEGF Drug Therapies: A Report of Three Cases. (PubMed, Int Med Case Rep J) - "This may be due to the fact that aflibercept (8 mg) is a fusion protein rather than an antibody, has lower clearance than a small molecule like brolucizumab, and has a higher anti-VEGF molar concentration than faricimab. It is suggested that aflibercept (8 mg) may be effective for DME in vitrectomized eyes and may merit preferential administration in such cases."

Journal • Diabetic Macular Edema • Hematological Disorders • Ophthalmology • Retinal Disorders

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

New P2 trial • Diabetic Macular Edema • Macular Edema • Ophthalmology

Clinical study protocol to observe the effect of intravitreal injection of faricimab on the maturity improvement of neovascular age-related macular degeneration (nAMD) with type I macular neovascularization (MNV) by optical coherence tomography angiography (OCTA) (ChiCTR) - P=N/A | N=30 | Not yet recruiting | Sponsor: West China Hospital of Sichuan University; West China Hospital of Sichuan University

New trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A single-arm, multi-center, open-label Phase IV clinical trial of faricimab for the treatment of diabetic macular edema (DME) patients (ChiCTR) - P4 | N=60 | Not yet recruiting | Sponsor: Inner Mongolia Chaoyu Eye Hospital; Inner Mongolia Chaoyu Eye Hospital

New P4 trial • Diabetic Macular Edema • Ophthalmology

Occlusive Retinal Vasculitis After Aflibercept 8mg Injection for Wet Macular Degeneration. (PubMed, Retin Cases Brief Rep) - "ORV is a rare complication of some intravitreal anti-VEGF medications and infectious causes of endophthalmitis. It can be managed with aggressive steroid treatment for an excellent visual outcome in some cases, although the disease may be chronic or recurrent."

Journal • Age-related Macular Degeneration • Inflammation • Macular Degeneration • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders • Uveitis • Vasculitis • Wet Age-related Macular Degeneration

Switch to faricimab in various retinal diseases: real-world data (ARVO 2025) - "Previous treatments included bevacizumab, ranibizumab, aflibercept 2mg, brolucizumab, triamcinolone, and Ozurdex. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • Real-world • Real-world evidence • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Efficacy of the Treat-and-Extend Regimen in the Management of Neovascular Age-related Macular Degeneration: 10-year Results of the RENO Study (ARVO 2025) - "The T&E regimen has been effective in maintaining visual acuity in nAMD patients treated with ranibizumab, aflibercept, bevacizumab, brolucizumab, or faricimab for up to ten years of treatment. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

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

Effects of Socioeconomic Factors on Management and Visual Outcome in Wet Age-Related Macular Degeneration Patients (ARVO 2025) - "Methods This retrospective study analyzed data from 579 patients with neovascular age-related macular degeneration (nAMD) who were treated with aflibercept, bevacizumab, ranibizumab, brolucizumab, and/or faricimab at Bascom Palmer Eye Institute between 2016 and 2024. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

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

A Systematic Review and Meta-Analysis: Treatment Patterns and Clinical Outcomes for Diabetic Macular Edema (ARVO 2025) - "Methods A meta-analysis of randomized control trials and retrospective studies was conducted via a search of PubMed, EMBASE, and Web of Science for "diabetic macular edema" AND "visual acuity" AND one of the following therapies: triamcinolone, dexamethasone, fluocinolone acetonide, focal laser, ranibizumab (RBZ), bevacizumab (BVZ), aflibercept (AFL), faricimab, or brolucizumab using PRISMA guidelines.Studies that were 3-24 months in duration and included data on BCVA, CRT, and/or treatment frequency were included. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical data • Retrospective data • Review • Diabetic Macular Edema • Ophthalmology

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

Treatment interval extension and morphological improvement in nAMD following switch to faricimab (ARVO 2025) - "Purpose To evaluate the efficacy of faricimab in patients with neovascular age-related macular degeneration (nAMD) not responding to other VEGF inhibitors Methods This study included nAMD patients with poor response to anti-VEGF treatment with aflibercept, bevacizumab and ranibizumab following the treat & extend regimen and who were switched to faricimab. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

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

Syfovre and Izervay Clinical Outcomes (ARVO 2025) - "One eye developed RV confirmed by angiography and was treated with prednisone, difluprednate, and pressure-lowering drops; at month 2, logMAR VA plateaued at 1.3 from 0.47. One eye underwent RD repair following IVS and IV faricimab...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • Clinical data • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders

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

Comparative Analysis of Systemic Complications of Anti-VEGF Therapies in Retinal Diseases: A Propensity-Score Matched Analysis (ARVO 2025) - "We identified adults receiving bevacizumab, ranibizumab, and aflibercept from 2012-2022 and categorized them into three separate cohorts, comparing the bevacizumab cohort to the latter two agents. We also identified adults taking faricimab, a newer anti-VEGF agent, from 2022-2024 to compare against a bevacizumab cohort for the same timeframe...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

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