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

Two-year results of switching to intravitreal administration of faricimab in patients with aflibercept-refractory neovascular age-related macular degeneration (Nature) - "At 24 months, 22 eyes (70.0%) achieved a dry macula and had improved VA levels with an improvement of 0.80 lines, which was significantly different from the remaining 9 eyes (P < 0.01). The mean interval of IVF was 11.8 weeks, which was significantly longer than that of aflibercept (10.0 weeks) at baseline (p = 0.014). Progression of macular atrophy or newly developing macular atrophy was seen in 3 eyes (9.7%), showing decline of 1.0 line, no other complications were seen. These results indicate that switching to IVF stabilized VA, significantly improved the anatomical changes and the achievement of a dry macula was significantly associated with the visual outcome, in patients with aflibercept-refractory nAMD over a 24-month period."

Real-world evidence • Age-related Macular Degeneration

The impact of swithching faricimab in the treatment of neovascular age-related macular degeneration: a real-world analysis. (PubMed, Graefes Arch Clin Exp Ophthalmol) - No abstract available

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

AP: Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of PDR (clinicaltrials.gov) - P3 | N=426 | Not yet recruiting | Sponsor: Jaeb Center for Health Research | Trial completion date: Mar 2031 ➔ Aug 2031 | Initiation date: Mar 2025 ➔ Aug 2025 | Trial primary completion date: Mar 2029 ➔ Aug 2029

Trial completion date • Trial initiation date • Trial primary completion date • Diabetic Retinopathy • Retinal Disorders

An assessment of anti-VEGF drugs safety based on real-world data: from popularity to spontaneous reporting in eudravigilance database. (PubMed, Graefes Arch Clin Exp Ophthalmol) - "Anti-VEGF drugs often cause ocular ADRs when treating nAMD, which should be a clinical concern. To reduce the risk of adverse reactions, clinicians should closely monitor patients using these drugs."

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

Morphometric Changes In Macular Neovascularization Architecture After Faricimab Treatment In Neovascular Age-Related Macular Degeneration: Comparison Between Naïve And Switched Eyes. (PubMed, Retina) - "Faricimab induces significant and sustained remodeling of the MNV network in nAMD, with more pronounced changes in treatment-naïve eyes. These changes were primarily driven by the loading phase, but then remained stable toward the one-year follow-up."

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

Real-World Outcomes in Eyes with Neovascular AMD Switched from Brolucizumab to Faricimab: A TRUCKEE Study Analysis: From Brolucizumab to Faricimab: A TRUCKEE Study Analysis. (PubMed, Am J Ophthalmol) - No abstract available

Journal • Real-world evidence • Wet Age-related Macular Degeneration

Intraocular Inflammation Following Intravitreal Faricimab: Insights from Five Bilateral Cases. (PubMed, J Vitreoretin Dis) - "Cases were characterized by a delayed onset of subacute symptoms after injection, keratic precipitates, and elevated intraocular pressure. Although the overall incidence of faricimab-related IOI is low, our findings highlight the need for increased vigilance in patients receiving bilateral faricimab injections."

Journal • Diabetic Retinopathy • Inflammation • Ocular Inflammation • Retinal Disorders

Real-World Efficacy and Durability of Faricimab in Aflibercept-Resistant Neovascular Age-Related Macular Degeneration. (PubMed, J Clin Med) - "Furthermore, the dry macula rate was 43.3% at month 6. Switching to faricimab in aflibercept-resistant nAMD patients showed stable visual outcomes, significant anatomical improvements, and reduced treatment burden over 6 months in real-world clinical settings."

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

VABYSMO (faricimab injection) Now Publicly Funded For Macular Edema Secondary to Retinal Vein Occlusion (RVO) and Pre-Filled Syringe (PFS) in Quebec (Canada Newswire) - "This latest update also includes funding for Vabysmo in a 6.0 mg single-use pre-filled syringe (PFS), providing an additional option and expanded access for patients in Quebec."

Reimbursement • Retinal Vein Occlusion

Durability of Three Monthly Loading Doses With Faricimab in Treatment-naïve Neovascular Age-related Macular Degeneration (clinicaltrials.gov) - P=N/A | N=833 | Active, not recruiting | Sponsor: Rigshospitalet, Denmark | Trial completion date: May 2025 ➔ Sep 2025

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

One-year outcomes of faricimab for neovascular age related macular degeneration with OCT angiography: focus on resistant and refractory cases. (PubMed, Int Ophthalmol) - "Faricimab demonstrated efficacy and safety in refractory/resistant nAMD, with significant improvements in structural outcomes and stable/improved visual acuity. Extended treatment intervals suggest a potential reduction in treatment burden."

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

Intravitreal Faricimab in Patients With Refractory Macular Edema (clinicaltrials.gov) - P2 | N=43 | Completed | Sponsor: Baghdad college of medicine

New P2 trial • Age-related Macular Degeneration • Macular Degeneration • Macular Edema • Ophthalmology • Retinal Disorders

Therapeutic Prospects of Faricimab Injection for Patients Affected by Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P=N/A | N=35 | Not yet recruiting | Sponsor: Hui Peng

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

Development of oral plasma kallikrein inhibitors for the treatment of diabetic macular edema and diabetic retinopathy (ACS-Fall 2025) - "Treatments like faricimab (Vabysmo®) feature dual ligand trap pharmacology targeting both VEGF and Ang2 in ocular tissue represent a new standard of care for patients via intravitreal injection.Emerging efforts targeting mechanisms that can be supported from peripheral dosing offer unique options for patients. Oral administration can minimally address patient compliance, and by targeting orthogonal mechanisms, may extend efficacy in treating patients that exhibit sub-optimal response, or in fact, offer viable treatment options in the earliest stages of disease.Herein, we report on our efforts to develop oral Plasma Kallikrein Inhibitors for the treatment of Diabetic Macular Edema (DME) and DR. The discussion will encompass our development of two orthogonal lead series with an emphasis on key ADME learnings from these efforts to establish both foundational tissue distribution, as well as the potential for low dose compounds."

Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders

One-year outcomes of three-monthly and four-monthly loading regimens of faricimab for treatment-naïve neovascular age-related macular degeneration. (PubMed, Graefes Arch Clin Exp Ophthalmol) - "What is known Faricimab, a bispecific antibody targeting both VEGF-A and Ang-2, is emerging as a promising therapeutic for neovascular AMD. Although a four-dose loading regimen was adopted in the pivotal TENAYA and LUCERNE trials, its superiority over the more conventional three-dose protocol remains uncertain in clinical practice. What is new In this study, we directly compared the four- and three-monthly loading regimens and found no significant differences in the dosing intervals and morphological and functional efficacy at 1 year. For both typical age-related macular degeneration and polypoidal choroidal vasculopathy, the dosing intervals and morphological and functional efficacy were comparable between the four- and three-monthly loading regimens."

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

A prospective study to evaluate the alterations of early macular microcirculation following intravitreal injection of faricimab for macular edema secondary to branch retinal vein occlusion (ChiCTR) - P4 | N=44 | Not yet recruiting | Sponsor: The Second Affiliated Hospital of Chongqing Medical University; The Second Affiliated Hospital of Chongqing Medical University

New P4 trial • Macular Edema • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion

Comparison of 1-year outcomes after switching to faricimab in neovascular age-related macular degeneration previously treated with anti-VEGF agents with/without a loading phase. (PubMed, Jpn J Ophthalmol) - "Switching to faricimab with a loading phase followed by a TAE regimen may improve outcomes in previously treated eyes. Further studies are warranted to confirm these findings."

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

Outcomes After Switching to Faricimab in Neovascular Age-Related Macular Degeneration: Data From the Fight Retinal Blindness! Registry. (PubMed, Clin Exp Ophthalmol) - "We found that faricimab inactivated a significant proportion of CNV lesions that had been active using 1st generation VEGF inhibitors, with a significant extension of the treatment interval. A small reduction in VA occurred in switchers and eyes not switched through the same period."

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

Faricimab as Treatment for Sarcoid Uveitis With Refractory Cystoid Macular Edema. (PubMed, J Vitreoretin Dis) - "Treatment with intravitreal faricimab was initiated after systemic and topical prednisolone and oral ibuprofen failed. Color fundus photography also showed improvement in the optic disc swelling and resolution of the retinal macroaneurysm. Faricimab can be a promising treatment for refractory CME in patients with sarcoid uveitis."

Journal • Cardiovascular • Immunology • Macular Edema • Ocular Inflammation • Ophthalmology • Sarcoidosis • Uveitis

No Waiver For Faricimab: CDSCO Panel Asks Roche To Conduct Phase III Trial In India (Medical Dialogues) - "Roche Products (India) Pvt Ltd has been directed by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) to conduct a Phase III clinical trial in India for its drug Faricimab (VABYSMO), proposed for the additional indication of macular edema secondary to retinal vein occlusion (RVO)...During the latest meeting, the firm presented justification for the unmet need in India, along with long-term safety data from the global clinical trial for the proposed indication. Roche also reiterated its request for waiver of the local Phase III clinical trial, committing instead to conducting a Phase IV study in India for the proposed indication...However, the committee noted that appropriate and adequate long-term safety data for the drug product is not available in the Indian population....Given these concerns, the committee declined the waiver request."

New P3 trial • Retinal Vein Occlusion

Switching to Faricimab for Polypoidal Choroidal Vasculopathy with Real-World Outcomes in Refractory Cases - The FAR-PEARL Study Report 1. (PubMed, Clin Ophthalmol) - "PED resolved in 53% after the first dose, and in those needing repeat injections, the interval peaked after the fourth dose with no SRF, IRF, nor PED. The differential response to faricimab in PCV depends on disease type, with recurrent cases requiring fewer injections and recalcitrant cases requiring more intensive initial treatment; however, even recalcitrant eyes can achieve extended intervals after initial doses."

Journal • Real-world evidence • Age-related Macular Degeneration • Wet Age-related Macular Degeneration

Comparative efficacy of photodynamic therapy (PDT), ranibizumab, aflibercept monotherapy, and combination therapies for polypoidal choroidal vasculopathy: a network meta-analysis of randomized controlled trials. (PubMed, BMC Ophthalmol) - "Compared with monotherapy, combination therapies using anti-VEGF agents and PDT provide significant visual and anatomical advantages in managing PCV. These treatments are associated with improved efficacy and a reduced treatment burden while maintaining favorable safety profiles. However, further standardization of protocols and evaluation of long-term cost-effectiveness are crucial for improving clinical practice applications."

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

Efficacy of switching treatment to faricimab in recalcitrant neovascular age related macular degeneration - 6 month results after completion of the loading phase. (PubMed, Graefes Arch Clin Exp Ophthalmol) - "In recalcitrant nAMD, faricimab can improve CST and SFCT while maintaining visual acuity. Furthermore, greater durability could be achieved with faricimab at nine months as compared to ranibizumab or aflibercept. Further prospective randomized trials are warranted."

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

Efficacy of Faricimab in the Treatment of Diabetic Macular Edema and Faricimab-Related Changes in OCT and OCT Angiography. (PubMed, Pharmaceutics) - "The following parameters were analyzed: non-perfusion area (NPA), superficial capillary plexus (SCP) and deep capillary plexus (DCP), outer retinal flow area (ORFA), choriocapillaris flow area (CCFA) and foveal avascular zone (FAZ). Despite differences in the magnitude of improvement and time to improvement from the start of treatment with intravitreal injections of 6 mg faricimab, reductions in DME and improvements in OCTA parameters resulted in increased retinal blood flow and better visual acuity."

Journal • Diabetic Macular Edema • Ophthalmology

Initial Response After Switching to Aflibercept 8 mg for Neovascular Age-Related Macular Degeneration. (PubMed, J Clin Med) - "The drugs used prior to switching were faricimab in five eyes, brolucizumab in six eyes, and aflibercept 2 mg in 91 eyes, with a mean interval of 63.7 ± 20.0 days from the last pre-switch injection and 64.9 ± 20.1 days to the first post-switch visit. No ocular or systemic adverse effects were observed. As an initial response to switching to aflibercept 8 mg in a real-world setting, SRF and IRF completely resolved in approximately half of the patients, and sPED resolved in about 30% of cases."

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