Short-term outcomes of intravitreal faricimab for treatment-naïve neovascular age-related macular degeneration

Matsumoto, Hidetaka; Hoshino, Junki; Nakamura, Kosuke; Nagashima, Takashi; Akiyama, Hideo

doi:10.1007/s00417-023-06116-y

Cited by 30 publications

(14 citation statements)

References 35 publications

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Section: Discussionsupporting

confidence: 88%

“…Taking into account the findings of this study in conjunction with those of previous studies, comparable results were observed between faricimab and aflibercept treatment in terms of BCVA at 1 year post-treatment, improvement in retinal thickness, reduction in SCT, and regression of polyps 5 , 6 , 24 . Notably, a high-resolution ratio of retinal fluid in nAMD during the loading therapy phase was observed with faricimab treatment 6 , 24 . Moreover, the potential for inhibiting the expansion of macular atrophy 25 , prohibiting fibrosis 3 , 26 , along with the stability of choroidal vasculature attributable to protection against pericyte loss, was suggested with the use of faricimab over the long term.…”

Section: Discussionsupporting

confidence: 88%

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One-year outcomes and safety assessment of faricimab in treatment-naïve patients with neovascular age-related macular degeneration in Japan

Mukai,

Kataoka,

Tanaka

et al. 2024

Sci Rep

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This multicentre retrospective study evaluated the 1-year outcomes and safety profile of faricimab in treatment-naïve patients with neovascular age-related macular degeneration (nAMD). Fifty-five patients (57 eyes) underwent loading therapy comprising three monthly faricimab injections. If dryness was achieved by the third month, subsequent treat-and-extend (TAE) follow-up continued at a minimum 8-week interval thereafter. If wet macula persisted at the third month, a fourth dose was administered, followed by the TAE regimen. After 1 year, improvements in visual acuity (0.44 ± 0.46 [baseline] to 0.34 ± 0.48; p < 0.01) and central foveal thickness (326 ± 149 [baseline] to 195 ± 82 μm; p < 0.0001) were significant. Dry macula, characterised by the absence of intraretinal or subretinal fluid, was achieved in 65% of cases. Treatment intervals varied, ranging from 8 to 16 weeks, with 44% of eyes extending to a 16-week interval, followed by 33% at 8 weeks, 16% at 12 weeks, 5% at 14 weeks, and 2% at 10 weeks. Notably, 50% of the polypoidal choroidal vasculopathy patients exhibited complete regression of polypoidal lesions between 12 and 15 months. Faricimab treatment in nAMD patients induced significant improvements in central vision and retinal morphology. Two cases of retinal pigment epithelial tears and one case of iritis were reported as ocular complications.

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Section: Discussionsupporting

confidence: 88%

Section: Discussionsupporting

confidence: 88%

One-year outcomes and safety assessment of faricimab in treatment-naïve patients with neovascular age-related macular degeneration in Japan

Mukai,

Kataoka,

Tanaka

et al. 2024

Sci Rep

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“…Our findings are consistent with the results of the pivotal phase 3 TENAYA and LUCERNE trials, which demonstrated the non-inferiority of faricimab dosed up to Q16W compared to aflibercept Q8W, with similar ocular adverse event rates, and those of the retrospective clinical studies. 13,14,25,26 Our study extends these previous findings by examining the efficacy of faricimab in different subtypes of nvAMD, including tAMD and PCV, and PNV and non-PNV eyes. Although several studies have reported that nvAMD subtypes can affect disease management 15,27 we found that faricimab treatment resulted in significant improvements in BCVA in both the PCV and tAMD subtypes, suggesting that faricimab may be effective in managing a range of nvAMD presentations.…”

Section: Discussionsupporting

confidence: 73%

Short-Term Outcomes of 3 Monthly intravitreal Faricimab On Different Subtypes of Neovascular Age-Related Macular Degeneration

Tanaka,

Hata,

Tsuchikawa

et al. 2024

OPTH

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To evaluate the efficacy and safety of faricimab injections for treatment-naïve neovascular age-related macular degeneration (nvAMD) patients, including subtypes and pachychoroid phenotypes, and identify predictive factors for visual outcomes. Methods: nvAMD patients were prospectively recruited, receiving three monthly faricimab (6 mg) injections. Best-corrected visual acuity (BCVA) two months after the last injection (month 4) was compared between subtypes, and between pachychoroid neovasculopathy (PNV) and non-PNV eyes. Regression analysis determined factors influencing month 4 BCVA. Results:The study involved 23 patients (12 typical AMD [tAMD], 10 polypoidal choroidal vasculopathy [PCV], 1 retinal angiomatous proliferation [RAP]). Eleven exhibited PNV phenotype. Significant BCVA (P = 4.9 × 10 −4 ) and central retinal thickness (CRT) (P = 1.3 × 10 −5 ) improvements were observed post-faricimab treatment. The therapy demonstrated favourable results for both tAMD and PCV eyes, and non-PNV and PNV eyes. Faricimab achieved dry macula in 77.3% of eyes, with subretinal fluid resolution in most cases, although intraretinal fluid (IRF) often persisted. Multivariable analysis identified external limiting membrane (ELM) presence and IRF as BCVA contributors at month 4. Conclusion: Faricimab demonstrated significant effectiveness and safety in treatment-naïve nvAMD patients, particularly for PCV and PNV eyes. ELM presence and IRF is predictive of visual outcomes.

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“…After the loading phase, complete regression of polypoidal lesions was observed in 61.1% of eyes (11 out of 18) with polypoidal lesions. A safety issue was observed: one eye (2.5%) experienced vitritis without loss of vision at week 16 [ 22 ].…”

Section: Neovascular Age-related Macular Degeneration (Namd)mentioning

confidence: 99%

Review of real-world evidence of dual inhibition of VEGF-A and ANG-2 with faricimab in NAMD and DME

Penha,

Masud,

Khanani

et al. 2024

Int J Retin Vitr

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Management of vitreoretinal disorders (e.g., neovascular age-related macular degeneration [nAMD] and diabetic macular edema [DME]) have assumed the standard therapy of lifelong anti-VEGF injections with drugs like aflibercept, brolucizumab, ranibizumab and bevacizumab. However, the burden imposed on patients is a major deterrent for continual therapy and recovery. Faricimab, a bispecific antibody, blocking both VEGF-A and Ang-2 molecules, produces a comparable functional and anatomical results, with less injections, significantly reducing patient burden. Visual acuity, safety, adverse effects, and anatomical outcomes are discussed in the pivotal clinical trials (YOSEMITE/RHINE and TENAYA/LUCERNE), and early data from real-world studies (TRUCKEE, TAHOE, FARWIDE-DME, FARETINA and others). In YOSEMITE and RHINE, faricimab demonstrated non-inferior vision gains, better anatomical outcomes compared to aflibercept every 8 weeks. Faricimab in the personalized treatment interval (PTI), after week 96, achieved 12-week interval in 78.1% of the patients and 16-week interval in 62.3%. TENAYA and LUCERNE reported comparable best corrected visual acuity (BCVA) improvement and better anatomic outcomes during head-to-head phase, parallel to aflibercept, at its 8-week treatment schedule. Faricimab in the PTI regimen, after week 96 achieved 12-week interval in 77.8% of the patients and 16-week interval in 63.1%. Safety of faricimab has been comparable to aflibercept in these pivotal trials. Real-world data supports the data from the pivotal studies regarding the efficacy and safety profile of faricimab in heterogenous real world patient population. Moreover, in previously treated patients, it also demonstrated a faster fluid resolution, good safety profile. Considering faricimab has demonstrated anatomic and durability benefit in the treatment of nAMD and DME, additional data from ongoing extension clinical trials, AVONELLE-X and RHONE-X will help understand longer term outcomes for patients treated with faricimab as well as patients switching from aflibercept to faricimab after finishing the pivotal trials. Longer term data from the real-world studies will also continue to contribute to our understanding of long-term efficacy, safety and durability in the real world patient population.

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Short-term outcomes of intravitreal faricimab for treatment-naïve neovascular age-related macular degeneration

Cited by 30 publications

References 35 publications

One-year outcomes and safety assessment of faricimab in treatment-naïve patients with neovascular age-related macular degeneration in Japan

One-year outcomes and safety assessment of faricimab in treatment-naïve patients with neovascular age-related macular degeneration in Japan

Short-Term Outcomes of 3 Monthly intravitreal Faricimab On Different Subtypes of Neovascular Age-Related Macular Degeneration

Review of real-world evidence of dual inhibition of VEGF-A and ANG-2 with faricimab in NAMD and DME

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