Roche Announces New Long-Term Clinical Data for Vabysmo (Faricimab) in nAMD and PCV

On September 5, Roche announced Faricimab.(Product name: Vabysmo)Latest Data from the AVONELLE-X and SALWEEN Studies.

Source: Roche Official Website

AVONELLE-X is aOpen-label, Multicenter, Two-year Extension StudyStudy, with a total inclusion of1029 NamesNeovascular or Wet Age-Related Macular Degeneration（nAMD）Subject.These subjects have completed one of the two Phase III clinical trials, namely the TENAYA study. (NCT03823287) Or LUCERNE Study(NCT03823300)。

In the Two Years of AVONELLE-XIn the study, patients' vision remained stable, and anatomical improvements compared to the parent trial were maintained with AVONELLE-X.ResultsShow that, over a period of four years,FaricimabAfter treatment,Nearly 80% of patients extended the treatment interval to once every three to four months., which further confirms the results of the TENAYA and LUCERNE studies.FaricimabWell tolerated, safety data consistent with that in nAConsistent with the known safety profile in MD treatment.

SALWEEN is a Phase IIIb/IV multicenter, open-label, single-group study designed to evaluateFaricimabTreating AsiaPolypoidal Choroidal Vasculopathy（PCV）The patient's outcome.

In the one-year data of the SALWEEN study,Average Best-Corrected Visual Acuity at Weeks 40, 44, and 48(BCVA) Improved by 8.9 letters from baseline, with clinical significance。In the first year, more than 50% of patients were assigned to the extended dosing regimen of 5 months.FaricimabThe abnormal polypoidal vessels specific to PCV also showed clinically significant effects, with complete regression of these lesions in over 60% of patients, and the majority... (86%) The polypoid lesion disappeared from the patient's eye.

In terms of safety,FaricimabWell tolerated, with a safety profile in PCV consistent with its known safety in nAMD.

Faricimab is the world's first bispecific antibody for ophthalmology to be marketed., compared with traditional single-pathway drugs, it can simultaneously target angiopoietin-2（Ang-2）And Vascular Endothelial Growth Factor A（VEGF-A）Two pathways, while inhibiting new blood vessel formation, also enhance vascular stability. Since its launch in 2022, the product's sales have grown rapidly, generating revenue of $4.379 billion in 2024. In the first half of this year, sales reached 2.067 billion Swiss francs.(Approximately 2.406 billion US dollars)。

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