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

EFFECTS OF FARICIMAB LOADING PHASE ON DIABETIC MACULAR EDEMA IN REAL-WORLD SETTING: An Optical Coherence Tomography Angiography Study. (PubMed, Retina) - "Faricimab loading phase showed promising results in visual outcomes and structural improvement in resistant diabetic macular edema."

Journal • Real-world evidence • Cardiovascular • Diabetic Macular Edema • Ophthalmology • Retinal Disorders

Long-term Outcomes of Faricimab in Previously Treated Neovascular Age-related Macular Degeneration. (PubMed, Ophthalmic Surg Lasers Imaging Retina) - "Switching from faricimab to another agent provided no added benefit. Faricimab demonstrated sustained anatomical improvement and treatment durability over 2.5 years, with a subset of patients showing lasting benefit."

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

MAGIC: Safety and Efficacy of Faricimab in Patients With NPDR (clinicaltrials.gov) - P2 | N=179 | Completed | Sponsor: Greater Houston Retina Research | Active, not recruiting ➔ Completed

Trial completion • Diabetic Retinopathy • Retinal Disorders

Beyond Cost: Faricimab as a Driver of Service Efficiency and Quality in Neovascular Age-Related Macular Degeneration Care. (PubMed, Ophthalmol Ther) - "In capacity-constrained settings, more durable options like faricimab can unlock operational capacity, enabling health systems to treat more patients, reduce delays, and more effectively achieve quality standards. These improvements not only help preserve vision but also generate economic value, as operational efficiencies can reduce service and litigation costs, complementing potential reductions in acquisition costs."

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

JADE: A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Intravitreal OLN324 (clinicaltrials.gov) - P1 | N=164 | Completed | Sponsor: Ollin Biosciences, Inc.

New P1 trial • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With Diabetic Macular Edema (DME) (clinicaltrials.gov) - P1 | N=93 | Recruiting | Sponsor: Genentech, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Diabetic Macular Edema • Ophthalmology

Response to Faricimab in refractory Caucasian Polypoidal Choroidal Vasculopathy (PCV) switchers. (PubMed, Retina) - "Switching to faricimab resulted in anatomical and functional stability in the majority of previously treated PCV patients and was well tolerated during the study period."

Journal • Age-related Macular Degeneration • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Vasculitis

Morphologic Changes of Macular Choroidal Neovascularization on OCT Angiography Following Faricimab Therapy in Patients With AMD. (PubMed, J Vitreoretin Dis) - "Notably, morphologic changes were seen on OCTA even when structural findings remained largely unchanged. Long-term faricimab therapy is associated with distinct morphologic changes in MNV seen on OCTA that were not observed with other anti-VEGF therapies, highlighting the added value of OCTA for assessing treatment response."

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

Cost-effectiveness analysis of the use of faricimab in diabetic macular edema in China. (PubMed, J Comp Eff Res) - "Faricimab, administered according to a personalized treatment interval regimen following four initial monthly injections, was compared with aflibercept (every 8 weeks) and with ranibizumab and conbercept (both following a pro-re nata dosing regimen). Sensitivity analyses confirmed the robustness of these results, consistently demonstrating faricimab as a dominant and cost-effective treatment option for DME. This first Chinese cost-effectiveness study of faricimab for DME shows it enhances visual outcomes and reduces costs, supporting its adoption and providing evidence for healthcare decision-making on reimbursement and resource allocation."

HEOR • Journal • Diabetes • Diabetic Macular Edema • Metabolic Disorders • Ophthalmology

VOYAGER: A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products (clinicaltrials.gov) - P=N/A | N=6000 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial primary completion date: Mar 2027 ➔ Nov 2026

Real-world evidence • Trial primary completion date • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Hypertensive Uveitis After Intravitreal Faricimab: Clinical and Methodological Considerations. (PubMed, Clin Exp Ophthalmol) - No abstract available

Journal • Ocular Inflammation • Ophthalmology • Uveitis

Ocular adverse events associated with aflibercept and faricimab: a population-based pharmacovigilance study. (PubMed, Can J Ophthalmol) - "In this study, faricimab generally showed lower point estimates for ROR of ocular AEs compared to 2 mg and 8 mg aflibercept; however, the wider confidence intervals for some outcomes reflect the limited number of reports and highlight the need for continued safety monitoring, particularly given the inherent reporting biases and lack of detailed patient or dosing information in the FAERS database."

Adverse events • Journal • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Uveitis

Medicare Trends in Intravitreal Anti-VEGF Use: A Population-Based Study (2014-2023). (PubMed, Ophthalmol Retina) - "Intravitreal anti-VEGF utilization among Medicare beneficiaries increased substantially from 2014 to 2023, driven primarily by growth in aflibercept use and rapid adoption of faricimab. Reimbursement for certain branded agents declined over time, while substantial geographic variation in injection rates persisted across states. Continued monitoring is warranted as biosimilars, emerging agents, and novel delivery systems enter the U.S. market."

Journal • Medicare • Reimbursement • US reimbursement • Cardiovascular • Ophthalmology

Measurement of Acute Intraocular Pressure Elevation Immediately After Intravitreal Anti-VEGF Injection and Analysis of Prefilled Syringe Accuracy. (PubMed, Clin Ophthalmol) - "The anti-VEGF agents including aflibercept 2 mg, aflibercept 8 mg, brolucizumab, faricimab, and ranibizumab-BS were assessed. Intravitreal injection using the aflibercept 2 mg prefilled syringe may deliver approximately 1.5 times the intended volume into the eye. This may raise safety concerns, such as the risk of transient vision loss due to marked immediate IOP elevation, and may also affect clinical outcomes and the validity of clinical trials."

Journal

Clinical spectrum of intraocular inflammation following faricimab intravitreal injections: evidence from a large real-life cohort in the United Kingdom. (PubMed, Eye (Lond)) - "This study describes one of the largest reported cohorts of IOI cases following faricimab treatment. It confirms that the incidence of IOI is rare and aligns with the rates of IVF-related adverse effects reported in clinical trials and in recent real-world studies. Overall, faricimab demonstrated a favourable safety profile with good prognosis in cases of IOI."

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

Real-World Outcomes and Choroidal Vascular Structural Changes After Switching to Faricimab in Neovascular Age-Related Macular Degeneration. (PubMed, J Clin Med) - " Switching to faricimab in patients with nAMD previously treated with other anti-VEGF therapies was associated with anatomical improvement, extended treatment intervals, and short-term visual gains, while choroidal vascular structure was maintained. Nonetheless, additional studies are warranted to more comprehensively evaluate the effectiveness of switching to faricimab, as well as the associated changes in choroidal vascular structure."

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

Dosing interval optimization and persistence with faricimab in age-related macular degeneration: An observational study in real-world clinical practice. (PubMed, Farm Hosp) - "Faricimab showed excellent persistence and extended dosing intervals in real-world practice. This is the first study specifically evaluating faricimab real-world persistence in nAMD."

Journal • Observational data • Real-world evidence • Age-related Macular Degeneration • Macular Degeneration • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Evolution of Anti-Vascular Endothelial Growth Factor Clinical Trial Design for Treating Neovascular Age-Related Macular Degeneration. (PubMed, J Vitreoretin Dis) - "Newer agents, such as faricimab and aflibercept 8.0 mg, have been evaluated in phase 3 RCTs and potentially offer extended durability of dosing in intervals of up to 12-16 weeks or longer. Recently introduced anti-VEGF agents were tested in pivotal trials using individualized, variable, extended treatment intervals, with results showing adequate nAMD control compared to older, fixed dosing regimens, but additional studies are needed to determine the real-world durability of these agents compared to older anti-VEGF agents."

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

Guiding syringe selection for intravitreal injections: injectability and stability analysis of compounded pegcetacoplan (SYFOVRE) and the broader implications for high-viscosity ophthalmic therapies. (PubMed, Int J Retina Vitreous) - No abstract available

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

Bilateral Eales' Disease Managed With Vitrectomy and Anti-VEGF Therapy: A Case Report. (PubMed, Am J Case Rep) - "We performed left-eye vitrectomy with cataract extraction, panretinal photocoagulation (PRP), and systemic immunosuppression with azathioprine, followed by methotrexate. One year later, right-eye disease progression required intravenous methylprednisolone, PRP, and preoperative intravitreal faricimab, followed by vitrectomy...Faricimab application highlights the utility of dual VEGF-A/Ang-2 pathway inhibition in surgical planning. Future studies will clarify anti-VEGF agent efficacies in this rare retinal vasculitis."

Journal • Cardiovascular • Cataract • Hematological Disorders • Ocular Inflammation • Ophthalmology • Retinal Disorders • Vasculitis

Twelve-month lesion reactivation after initial loading injections of faricimab in neovascular AMD: a comparison between three and four loading injections. (PubMed, BMC Ophthalmol) - No abstract available

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

Real-world treatment patterns and visual outcomes of faricimab in patients with neovascular age-related macular degeneration in the UK at 12 months: the FARWIDE-nAMD study. (PubMed, Eye (Lond)) - "These 1-year data support real-world faricimab effectiveness, durability, and safety in nAMD."

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

HANGANG: Efficacy and Durability of a Personalized Treat-and-extend Regimen of Faricimab for Treatment-naive Polypoidal Choroidal Vasculopathy (clinicaltrials.gov) - P3 | N=50 | Recruiting | Sponsor: Yeungnam University College of Medicine

New P3 trial • Age-related Macular Degeneration • Hematological Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders

Anti-VEGF Agents and the Inner Retina in nAMD: A Narrative Review of RNFL and Ganglion Cell Changes. (PubMed, Drug Des Devel Ther) - "Apparent between-agent differences were small and inconsistent; evidence specific to faricimab remains limited but generally reassuring for structural stability. Overall, most observed changes were often within OCT test-retest variability. In practice, clinicians should prioritise GCL/GCIPL monitoring where IRF is present, interpret small absolute changes against device repeatability, and avoid attributing trivial sectoral shifts to drug toxicity without corroboration."

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

Two initial faricimab loading doses in treatment-naive neovascular AMD (clinicaltrialsregister.eu) - P4 | N=50 | Active, not recruiting | Sponsor: Medical University Of Graz | Recruiting ➔ Active, not recruiting

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