Three-month outcomes of faricimab loading therapy for wet age-related macular degeneration in Japan

Mukai, Ryo; Kataoka, Keiko; Tanaka, Koji; Miyara, Yasunori; Maruko, Ichiro; Nakayama, Makiko; Watanabe, Yuto; Yamamoto, Akiko; Wakatsuki, Yu; Onoe, Hajime; Wakugawa, Sorako; Terao, Nobuhiro; Hasegawa, Taiji; Hashiya, Nozomu; Kawai, Moeko; Maruko, Ruka; Itagaki, Kanako; Honjo, Jyunichiro; Okada, Annabelle A.; Mori, Ryusaburo; Koizumi, Hideki; Iida, Tomohiro; Sekiryu, Tetsuju

doi:10.1038/s41598-023-35759-4

Cited by 33 publications

(12 citation statements)

References 28 publications

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“…Moreover, a complete regression of polypoidal lesions was observed in 52% of eyes with PCV. Regarding safety profile, two eyes developed retinal pigment epithelium tears, but no other ocular or systemic complications were observed [ 21 ].…”

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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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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“…Notably, by the 48-week mark, approximately 78–80% of patients were allocated a treatment interval of either 12 or 16 weeks 5 . However, real-world clinical settings often employ the treat-and-extend (TAE) regimen 7 as a common treatment strategy. Despite its widespread use, there is currently a dearth of reports on the treatment outcomes of faricimab when utilising TAE regimens over a period of 1 year.…”

Section: Introductionmentioning

confidence: 99%

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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“…The TENAYA and LUCENE trials showed that the effect of faricimab appears to be prolonged compared with that of aflibercept in terms of maintaining best-corrected visual acuity (BCVA) outcomes 13 . Following the introduction of faricimab, short-term studies reported improved BCVA and retinal morphology during the loading phase of intravitreal faricimab (IVF) treatment in patients with treatment-naïve nAMD 14 , 15 . A few studies have shown efficacy of IVF in nAMD patients who have shown resistance to aflibercept and/or bevacizumab 11 , 16 .…”

Section: Introductionmentioning

confidence: 99%

One-year visual and anatomical outcomes of intravitreal faricimab injection for neovascular age-related macular degeneration after prior brolucizumab treatment

Takahashi,

Inoda,

Takahashi

et al. 2024

Sci Rep

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This single-center retrospective cohort study analyzed the 1-year real-world treatment outcomes of 63 consecutive eyes (of 60 patients) with neovascular age-related macular degeneration (nAMD) that were switched from intravitreal brolucizumab (IVBr) to intravitreal faricimab (IVF) and managed on a treat-and-extend regimen with discontinuation criteria. After the switch, patients opted to continue IVF, to switch back to IVBr, or receive photodynamic therapy (PDT). Thirty-eight patients continued IVF, 16 patients were switched back to IVBr, 2 patients received PDT, and 4 patients paused treatment. Best-corrected visual acuity (BCVA), central subfield thickness (CST), subfoveal choroidal thickness (sf-CT), and injection intervals were compared immediately before and 1 year after the initial IVF. Whereas there was no change in BCVA and CST; 0 [− 0.0969 to 0.125, P = 0.58], − 1.5 [− 27.8 to 13.5, P = 0.11] µm, respectively, sf-CT decreased significantly; − 19.5 [− 45.5 to 7.75, P = 0.015] µm. The patients switched back showed no significant change in sf-CT. The injection interval extended significantly in the IVF continuation and the switch-back group (2.0 and 3.0 weeks, respectively; [P = 0.0007 and 0.0078]) in eyes with a pre-switching interval of less than 12 weeks. Faricimab shows promise as a safe and effective alternative to brolucizumab for treating nAMD.

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Three-month outcomes of faricimab loading therapy for wet age-related macular degeneration in Japan

Cited by 33 publications

References 28 publications

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

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

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

One-year visual and anatomical outcomes of intravitreal faricimab injection for neovascular age-related macular degeneration after prior brolucizumab treatment

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