☆ 4.4 Review

Efficacy, Durability and Safety of Faricimab in Neovascular Age-Related Macular Degeneration and Diabetic Macular Oedema: Lessons Learned from Registration Trials

OPHTHALMOLOGY AND THERAPY (2023)

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Polypoidal Choroidal Vasculopathy: An Update on Diagnosis and Treatment

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Summary: Polypoidal choroidal vasculopathy (PCV) is a vascular disease that leads to macular degeneration and vision loss. Non-invasive OCT criteria have shown reliable results for planning PDT treatment. Anti-VEGF monotherapy and its combination with PDT have been proven effective but pose challenges due to follow-up frequency and availability issues. Longer acting molecules like brolucizumab and newer therapies like Faricimab offer potential solutions to address these challenges.

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Article Ophthalmology

Faricimab in neovascular AMD: first report of real-world outcomes in an independent retina clinic

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Summary: This study assessed the short-term real-world outcomes of faricimab in treating neovascular age-related macular degeneration (nAMD). The results showed that faricimab treatment significantly improved visual acuity and anatomic parameters in nAMD patients, with no observed adverse events.

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Article Ophthalmology

The real-world efficacy and safety of faricimab in neovascular age-related macular degeneration: the TRUCKEE study-6 month results

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Summary: This study retrospectively analyzed real-world patients receiving faricimab for the treatment of neovascular age-related macular degeneration (nAMD). The results showed that faricimab can improve or maintain visual acuity and rapidly improve anatomical parameters. It was well-tolerated with a low incidence of treatable intraocular inflammation.

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Article Ophthalmology

Efficacy, durability, and safety of faricimab up to every 16 weeks in patients with neovascular age-related macular degeneration: 1-year results from the Japan subgroup of the phase 3 TENAYA trial

Ryusaburo Mori et al.

Summary: This article evaluated the 1-year efficacy, durability, and safety of faricimab compared to aflibercept in patients with neovascular age-related macular degeneration (nAMD) in the Japan subgroup of the TENAYA trial. The study showed that both faricimab and aflibercept had similar improvements in best-corrected visual acuity (BCVA) with adjusted mean BCVA changes of +7.1 and +7.7 letters, respectively. The use of faricimab every 16 weeks in the Japanese patients demonstrated sustained efficacy and an acceptable safety profile.

JAPANESE JOURNAL OF OPHTHALMOLOGY (2023)

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Editorial Material Ophthalmology

Faricimab phase 3 DME trial significance of personalized treatment intervals (PTI) regime for future DME trials

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EYE (2022)

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Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials

Jeffrey S. Heier et al.

Summary: The primary results of two Phase 3 trials show that faricimab can effectively improve visual acuity for patients with nAMD at intervals of up to 16 weeks, with comparable safety profile to aflibercept. This suggests that faricimab has the potential to reduce treatment burden by extending the time between injections while maintaining efficacy.

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Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials

Charles C. Wykoff et al.

Summary: This study demonstrates the efficacy and safety of faricimab in patients with diabetic macular edema. Treatment with faricimab every 8 weeks or personalized treatment interval dosing achieved non-inferiority and had good tolerability.

LANCET (2022)

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Review Ophthalmology

Evolving treatment paradigms for PCV

Beau J. Fenner et al.

Summary: PCV, a subtype of nAMD, is common in Asia and worldwide. Current treatment strategies involve anti-VEGF therapy and photodynamic therapy, but the optimal treatment approach and interval are unclear. New imaging modalities offer potential for guiding treatment initiation and re-treatment.

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Global Incidence, Progression, and Risk Factors of Age-Related Macular Degeneration and Projection of Disease Statistics in 30 Years: A Modeling Study

Yuye Wang et al.

Summary: AMD has become a major cause of visual impairment worldwide, especially in the elderly population. Smoking is identified as an independent risk factor for both early and late AMD, while age, high-density lipoprotein cholesterol and alcohol consumption are associated with early AMD incidence. The epidemiological estimates could inform effective strategies for preventing AMD globally.

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Article Pharmacology & Pharmacy

Faricimab: First Approval

Matt Shirley

Summary: Faricimab is a bispecific antibody that targets and inhibits both VEGF-A and Ang-2. It has received approvals for the treatment of nAMD and DME in the USA and is currently undergoing clinical development in other countries.

DRUGS (2022)

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Review Biochemistry & Molecular Biology

Biomarkers as Predictive Factors of Anti-VEGF Response

Miriam Bobadilla et al.

Summary: Researchers propose combining genomic, proteomic, and metabolomic markers with specific clinical characteristics to identify patients with poor response to anti-VEGF treatment and establish personalized treatment plans.

BIOMEDICINES (2022)

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Article Ophthalmology

Intravitreal Faricimab for Aflibercept-Resistant Neovascular Age-Related Macular Degeneration

Ryan B. Rush et al.

Summary: This study evaluated the short-term effects of intravitreal faricimab (IVF) in patients with treatment-resistant neovascular age-related macular degeneration (nAMD) previously treated with intravitreal aflibercept (IVA). The results showed that IVF can improve visual and anatomic outcomes in a significant minority of patients.

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Diabetic Macular Edema: Current Understanding, Molecular Mechanisms and Therapeutic Implications

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Summary: Diabetic retinopathy and diabetic macular edema are major causes of vision loss and blindness in working-age adults, with Vascular endothelial growth factor (VEGF) playing a key role in their pathogenesis. Intravitreal injection of anti-VEGF agents is the main treatment for DME, but not all patients respond well to this therapy.

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Faricimab for Treatment-Resistant Diabetic Macular Edema

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Summary: This study retrospectively assessed the short-term outcomes of switching from intravitreal aflibercept (IVA) to intravitreal faricimab (IVF) in treatment-resistant diabetic macular edema (DME) patients. The results showed that IVF can improve the visual and anatomical outcomes in a significant minority of DME patients who were previously managed with IVA. Longer follow-up is needed to determine if these improvements can be maintained.

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Visual acuity outcomes and anti-VEGF therapy intensity in diabetic macular oedema: a real-world analysis of 28 658 patient eyes

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Summary: The study evaluated visual acuity outcomes and anti-vascular endothelial growth factor (anti-VEGF) treatment intensity in diabetic macular oedema (DMO) patients. Patients with better baseline visual acuity may experience loss of vision at 1 year, while those with moderately severe baseline impairment could improve with more injections. Visual outcomes are correlated with treatment intensity at 1 year.

BRITISH JOURNAL OF OPHTHALMOLOGY (2021)

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Nonadherence or Nonpersistence to Intravitreal Injection Therapy for Neovascular Age-Related Macular Degeneration A Mixed-Methods Systematic Review

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Summary: Despite advancements in treating diabetic macular edema and retinopathy, limited medical resources contribute to lower fundus examination rates, delaying diagnosis and treatment. Implementation of automated screening programs and identification of specific biomarkers are crucial for early detection, reducing the prevalence of poor vision and blindness.

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JAMA OPHTHALMOLOGY (2020)

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