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

Twelve-Month Real-World Outcomes of Faricimab for Treatment-Naive Neovascular AMD in Australia. (PubMed, Clin Exp Ophthalmol) - "These findings indicate that faricimab is safe and effective for treatment-naive eyes with nAMD. Faricimab had a stronger effect on nAMD lesion activity than aflibercept 2 mg."

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

Potential 20-week Faricimab Dosing in Wet Age-Related Macular Degeneration. (PubMed, Ophthalmol Retina) - "Patients with nAMD in TENAYA/LUCERNE always on extended faricimab dosing (≥12-weeks) achieved robust disease control throughout 2 years. Additionally, 56% of patients could have potentially extended to every-20-week dosing had the protocol allowed."

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

Intravitreal faricimab in patients with refractory diabetic macular edema: 6-month fluid analysis using artificial intelligence. (PubMed, BMC Ophthalmol) - "Faricimab treatment led to modest early improvements in visual acuity and retinal anatomy overall in patients with refractory DME. The reduction in total IRF at Month 4 may be attributable to Ang-2 inhibition in these patients, who had previously not responded to anti-VEGF treatment alone. Longer-term studies are needed to evaluate the durability and long-term efficacy of faricimab for the treatment of refractory DME."

Journal • Diabetes • Diabetic Macular Edema • Diabetic Retinopathy • Metabolic Disorders • Ophthalmology • Retinal Disorders

Comparative effectiveness and safety landscape of anti-VEGF therapies for neovascular age-related macular degeneration: Insights from a systematic review and network meta-analysis. (PubMed, Biomed Pharmacother) - "All anti-VEGF agents stabilize or improve vision in nAMD. Aflibercept may provide the most favorable efficacy-safety balance, Faricimab offers promising durability, and Brolucizumab demonstrates large visual gains with potential safety concerns. Further head-to-head and long-term real-world studies are needed to optimize individualized treatment strategies."

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

Real-life data of the IVI interval after switching to faricimab therapy (PubMed, Ophthalmologie) - "Switching to faricimab resulted in a significant extension of treatment intervals in both indications, with patients with DME deriving the greatest benefit. Limitations include the small sample size and potential selection bias. These findings suggest an improved benefit-risk profile through reduced injection frequency. Additional real-world data and meta-analyses may help identify biomarkers to further individualize anti-VEGF therapy in the future."

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

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports strong 2025 results with 7% sales growth (Roche Press Release) - "Pharmaceuticals Division sales increased by 9% (3% in CHF), with Phesgo (breast cancer), Xolair (food allergies), Ocrevus (multiple sclerosis), Hemlibra (haemophilia A) and Vabysmo (severe eye diseases) being the top growth drivers."

Commercial • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Diabetic Macular Edema • Diabetic Retinopathy • Hemophilia A • HER2 Positive Breast Cancer • Multiple Sclerosis • Wet Age-related Macular Degeneration

Long term follow up of faricimab intravitreal injections in naïve neovascular age related macular degeneration. (PubMed, Ophthalmic Res) - "Faricimab showed efficacy in the treatment of naïve nAMD patients with an improvement of many anatomical and functional parameters at 44 weeks allowing to maintain a treatment regimen for most patients equal to or greater than 12 weeks."

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

Choroidal Neovascularization and Extensive Macular Atrophy With Pseudodrusen: a Retrospective Comparative Case Series. (PubMed, J Vitreoretin Dis) - "Treatments included aflibercept (7 eyes), ranibizumab (1 eye), and 1 eye treated with combination therapy with aflibercept, ranibizumab, and faricimab (mean 8 injections/eye); 3 eyes had incomplete treatment information and 3 eyes did not receive treatment. Early CNV diagnosis is crucial for timely treatment initiation, aiming to optimize anatomic and functional outcomes. While visual responses varied, our findings indicate that anti-VEGF therapy plays a significant role in stabilizing or improving vision."

Journal • Retrospective data • Age-related Macular Degeneration • Dry Age-related Macular Degeneration

Beyond drug price: A comparison of overall costs of anti-vascular endothelial growth factor therapy alternatives for neovascular age-related macular degeneration in Norway. (PubMed, Acta Ophthalmol) - "In our model, longer-acting agents reduced injection frequency and decreased overall treatment costs. These findings suggest that adopting longer-acting monotherapy could improve cost-efficiency in long-term nAMD management in Norway."

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

Antibody-based therapeutics and therapeutic development for diabetic retinopathy: targeting VEGF, Ang/Tie, and inflammatory pathways. (PubMed, Front Endocrinol (Lausanne)) - "Recent clinical innovations include ophthalmic formulations of bevacizumab, high-dose aflibercept, the ranibizumab port delivery system, and bispecific antibodies like faricimab that simultaneously target VEGF and angiopoietin-2 pathways, alongside emerging preclinical investigations into novel targets and bio-engineered delivery platforms. Despite therapeutic advances, significant challenges persist, including cost-effectiveness concerns, treatment burden, and adherence issues. This review highlights the transformative impact of mAb therapy in DR management while acknowledging the need for continued innovation to address existing limitations and optimize patient outcomes through personalized treatment approaches."

Journal • Review • Diabetes • Diabetic Retinopathy • Macular Edema • Metabolic Disorders • Ophthalmology • Retinal Disorders • IL17A • IL1B • IL6

Diabetic Macular Edema (DME) Patient Response to Faricimab and Associated Aqueous Humor Proteomic Differences Pre- and Post-Treatment (ChiCTR) - P=N/A | N=154 | Not yet recruiting | Sponsor: Tianjin Medical University Eye Hospital; Tianjin Medical University Eye Hospital

New trial • Diabetic Macular Edema • Ophthalmology

Clinical study of faricimab in the treatment of macular edema secondary to branch retinal vein occlusion in treatment-naive patients (ChiCTR) - P=N/A | N=40 | Not yet recruiting | Sponsor: The First People's Hospital of XuZhou; The First People's Hospital of XuZhou

New trial • Macular Edema • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion

Ollin Biosciences Announces Positive Topline Data with Superior Outcomes from a Randomized Head-to-Head Study of OLN324 Compared to Faricimab (Vabysmo) in Diabetic Macular Edema and Wet Age-Related Macular Degeneration (GlobeNewswire) - "OLN324 demonstrated both faster and greater retinal drying versus faricimab in patients with DME, with OLN324 4mg treated patients experiencing mean improvements in retinal drying that were ~75% greater than faricimab at Week 1 (-79 µm vs. -45 µm mean change in central subfield thickness or CST, respectively), and ~50% greater at Week 12 (-180 µm vs. -121 µm), measured using optical coherence tomography (OCT)....Ollin plans to discuss the JADE study and additional pipeline and corporate progress during its upcoming presentation at the 44th Annual J.P. Morgan Healthcare Conference, on Tuesday, January 13, 2026. Full results of the study will be presented for the first time at the upcoming Angiogenesis, Exudation, and Degeneration 2026 symposium on February 7, 2026."

P1 data • Pipeline update • Diabetic Macular Edema • Wet Age-related Macular Degeneration

The AVONELLE-X study was a two-year open-label extension of the two-year Phase III TENAYA and LUCERNE studies of Vabysmo in wet AMD. (Genentech Press Release) - "Vision remained stable throughout the two years of AVONELLE-X, and anatomic improvement from the parent trials was sustained through AVONELLE-X. Results showed that after up to four years of treatment with Vabysmo, nearly 80% of patients had extended their treatment intervals to every three or four months, reinforcing the results seen in TENAYA and LUCERNE. Vabysmo was well tolerated, and safety data were consistent with its known safety profile in wet AMD."

P3 data • Age-related Macular Degeneration • 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

First-year real-world outcomes of faricimab in clinically significant diabetic macular oedema: a Swiss retina research network report. (PubMed, BMJ Open Ophthalmol) - "Over 12 months, faricimab demonstrated good efficacy and safety in both treatment-naïve and pretreated eyes with DME. There was a reduction in CST and improved VA in treatment-naïve eyes and stable VA in pretreated eyes. The low number of AEs supports a favourable risk-benefit profile of faricimab in a real-world setting."

Journal • Real-world evidence • Retrospective data • Diabetic Macular Edema • Diabetic Retinopathy • Inflammation • Macular Edema • Ocular Infections • Ophthalmology • Retinal Disorders

Intraocular Inflammation After Intravitreal Faricimab Injections: A Case Series. (PubMed, Clin Exp Ophthalmol) - "Non-infectious hypertensive uveitis can occur subacutely after intravitreal faricimab injections. It is imperative that intraocular pressure is promptly managed to reduce the risk of permanent glaucomatous damage. As all our patients presented with anterior vitreous involvement, it is also practical that such cases of IOI are not mistaken for infectious exogenous endophthalmitis to avoid unnecessary treatment with intravitreal antibiotics and surgery."

Journal • Glaucoma • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Uveitis

Real-world database evaluation of drug-associated vitreous opacities and machine learning for clinical interpretability. (PubMed, Front Cell Dev Biol) - "The five highest-risk drugs were dexamethasone, brolucizumab, triamcinolone, faricimab, and fingolimod. This first systematic real-world evaluation of VO-related adverse drug reactions identifies high-risk drugs, susceptible populations, and onset patterns, thus offering guidance for preventive medication strategies. The BAG model showed higher sensitivity in real-world analysis, suggesting potential for further research in VO and floater prevention and treatment."

Journal • Real-world evidence

Domestic sales (Chugai Press Release) - "Specialty product sales were ¥225.8 billion (an increase of 5.8% year on year). This was primarily due to the strong sales of the mainstay product Vabysmo (an ophthalmic VEGF/Ang-2 inhibitor, anti-VEGF/anti Ang-2 humanized bispecific monoclonal antibody), Enspryng (pH-dependent binding humanized anti-IL-6 receptor monoclonal antibody), and Hemlibra (a blood coagulation factor VIII substitute/anti-coagulation factor IXa/X humanized bispecific monoclonal antibody), as well as the favorable market penetration of the new product PiaSky (a pH dependent binding humanized anti-complement (C5) monoclonal antibody), despite the market penetration of generic drugs and the effects of the NHI drug price revisions. Meanwhile, compared to the full year forecast announced on January 30, 2025, domestic sales increased by 2.1% to ¥472.4 billion, due to the increased sales of Hemlibra, Enspryng, Vabysmo, etc."

Commercial • Age-related Macular Degeneration • Diabetic Macular Edema • Hemophilia A • Neuromyelitis Optica Spectrum Disorder • Paroxysmal Nocturnal Hemoglobinuria • Retinal Vein Occlusion

Health Canada Authorizes Vabysmo (faricimab injection) Pre-Filled Syringe (PFS) for Three Leading Causes of Vision Loss (Canada Newswire) - "Hoffmann-La Roche Limited (Roche Canada) is pleased to announce today that Health Canada has authorized Vabysmo (faricimab injection) for use in a 6.0 mg single-use pre-filled syringe (PFS) for use in the treatment of wet, or neovascular, age-related macular degeneration (AMD), diabetic macular edema (DME) and macular edema secondary to retinal vein occlusion (RVO). These leading causes of vision loss affect around 70 million people worldwide and can have a serious impact on patients, their families, and caregivers. Supply for Vabysmo PFS will become available to Canadian ophthalmologists and their patients in the coming months."

Canada approval • Launch Canada • Age-related Macular Degeneration • Diabetic Macular Edema • Retinal Vein Occlusion

Roche’s Vabysmo expands indication to retinal vein occlusive macular edema (Korea Biomedical Review) - "Roche Korea's Vabysmo (faricimab) has been approved for treating retinal vein occlusive macular edema. Roche Korea said Wednesday that the Ministry of Food and Drug Safety (MFDS) has approved Vabysmo for treating vision impairment caused by retinal vein occlusive macular edema....The MFDS approved the expanded indication for treating vision loss due to retinal vein occlusive macular edema based on results from the BALATON and COMINO global phase 3 clinical trials, which involved more than 1,200 patients with retinal vein occlusive macular edema."

Korea approval • Macular Edema • Retinal Vein Occlusion

nAMD: Evaluate the Efficacy of Faricimab in Patients With Neovascular Age-related Macular Degeneration (clinicaltrials.gov) - P4 | N=64 | Not yet recruiting | Sponsor: Junyeop Lee

Biomarker • New P4 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

MAGIC: Study Design and Rationale for the Phase 2 Clinical Trial of Faricimab for Non-Proliferative Diabetic Retinopathy. (PubMed, Ophthalmologica) - P2 | "MAGIC is a randomized clinical trial that assesses RNP progression among eyes with NPDR, including its natural history and the impact of faricimab. Its innovative study design also explores the utility of novel assessments of retinal physiology and function."

Clinical • Journal • P2 data • Diabetic Retinopathy • Hematological Disorders • Retinal Disorders

Massive Submacular Hemorrhage Following Intravitreal Faricimab Injection for Neovascular Age-Related Macular Degeneration. (PubMed, Cureus) - "While faricimab has demonstrated a favorable safety profile and lower hemorrhagic events compared to other anti-vascular endothelial growth factor agents, SMH, in specific, is not listed among the significant adverse events in available clinical trial safety data or in postmarketing pharmacovigilance analyses. This case highlights a new severe hemorrhagic complication that can cause permanent visual damage related to faricimab even in well-monitored patients."

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

Intraocular inflammation incidence and real-world safety of intravitreal faricimab treatment across retinal indications. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "Overall, IOI risk ranged from approximately 0.5 to 1.2%, with higher rates observed among patients with DME and RVO. These findings highlight the importance of ongoing pharmacovigilance as newer retinal therapeutics enter clinical practice, and they provide timely evidence to support safety monitoring in real-world ophthalmology settings."

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