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. 2024 Feb 20:18:507-516.
doi: 10.2147/OPTH.S448507. eCollection 2024.

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

Asako Tanaka  1 , Masayuki Hata  1 , Memiri Tsuchikawa  1 , Naoko Ueda-Arakawa Ueda-Arakawa  1 , Hiroshi Tamura  1 , Manabu Miyata  1 , Ayako Takahashi  1 , Ai Kido  1 , Yuki Muraoka  1 , Masahiro Miyake  1 , Sotaro Ooto  1 , Akitaka Tsujikawa  1
Affiliations

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

Asako Tanaka et al. Clin Ophthalmol. .

Abstract

Purpose: 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.

Keywords: CRT; ELM; IRF; MNV; PCV; PNV; RAP; anti-VEGF; anti-vascular endothelial growth factor; central retinal thickness; external limiting membrane; faricimab; intraretinal fluid; macular neovascularization; neovascular age-related macular degeneration; nvAMD; pachychoroid neovasculopathy; polypoidal choroidal vasculopathy; retinal angiomatous proliferation.

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Conflict of interest statement

M Hata: Novartis Pharma, Senju Pharmaceutical, Alcon Research Institute, and Kyoto Drug Discovery and Development; A. N Ueda-Arakawa: Santen Pharmaceutical, Novartis Pharma, and Chugai Pharmaceutical; H. Tamura: Findex, Bayer Yakuhin, Novartis Pharma, Santen Pharmaceutical, SUNTORY, and Otsuka Pharmaceutical; M Miyata: Alcon Japan, Novartis Pharma, Santen Pharmaceutical, HOYA, Bayer Yakuhin, Senju Pharmaceutical, and Kowa Pharmaceutical; A. Takahashi: Bayer Yakuhin, Novartis Pharma, Santen Pharmaceutical, and MSD; Y. Muraoka: Rohto Pharmaceutical, Bayer Yakuhin, Novartis Pharma, Alcon Japan, Canon, Santen Pharmaceutical, Senju Pharmaceutical, AMO Japan, HOYA, Johnson & Johnson K.K.; M Miyake: Novartis Pharma, Bayer Yakuhin, Kowa Pharmaceutical, Alcon Japan, AMO Japan, Santen Pharmaceutical, Senju Pharmaceutical, Johnson and Johnson K. K., and Chugai Pharmaceutical; S. Ooto: Bayer Yakuhin, Kowa Pharmaceutical, Janssen Pharmaceutical, Novartis Pharma, AMO Japan, Santen Pharmaceutical, Alcon Japan, and Senju Pharmaceutical; A. Tsujikawa: Canon, Findex, Santen Pharmaceutical, Kowa Pharmaceutical, Pfizer, Sumitomo Pharma, Rhoto Pharmaceutical, Nippon Boehringer Ingelheim, Nidek, Johnson & Johnson, Nikon Solutions, AMO Japan, Senju Pharmaceutical, Wakamoto Pharmaceutical, Alcon Japan, Alcon Pharma, Otsuka Pharmaceutical, Tomey Corporation, Taiho Pharma, Hoya, Bayer Yakuhin, Novartis Pharma, Chugai Pharmaceutical, Astellas, Eisai, Daiich-Sankyo, Janssen Pharmaceutical, Kyoto Drug Discovery and Development, Allergan Japan, MSD, Ellex, HOYA, Sanwa Kagaku Kenkyusho, Nitten Pharmaceutical, and AbbVie GK. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Treatment protocol. Intervention schedule for patients with age-related macular degeneration treated with faricimab. We administered three, monthly injections of 6 mg faricimab, and evaluated the efficacy two months after the third injection (month 4). Clinical data were collected at baseline and month 4. ×, Faricimab injection (6 mg); 〇, clinical data collection; □, efficacy endpoint.
Figure 2
Figure 2
Visual and anatomic outcome of age-related macular degeneration (AMD) eyes treated with faricimab. (A and B) Changes in the logarithm of minimum angle resolution (logMAR) visual acuity (VA) in total eyes (A), and typical age-related macular degeneration (tAMD) and polypoidal choroidal vasculopathy (PCV) eyes (B). (C–F) Changes in central retinal thickness (CRT) (C), subfoveal choroidal thickness (SFCT) (D), maximum pigment epithelial detachments (PED) height (E), and maximum subretinal hyperreflective material (SHRM) height (F) in total eyes. *P < 0.05, **P < 0.005, ***P < 0.001 compared between two groups (A and C–F), and between baseline and month 4 (B).
Figure 3
Figure 3
Comparison of visual and anatomic outcome between age-related macular degeneration (AMD) with and without pachychoroid phenotypes. Changes in the logarithm of minimum angle resolution (logMAR) visual acuity (VA) (A), subfoveal choroidal thickness (SFCT) (B), central retinal thickness (CRT) (C), maximum pigment epithelial detachments (PED) height (D), and maximum subretinal hyperreflective material (SHRM) height (E) in age-related macular degeneration (AMD) with and without pachychoroid phenotypes. *P < 0.05, **P < 0.005, ***P < 0.001 compared between baseline and month 4 (A–E), and †P < 0.05 compared between eyes with and without pachychoroid phenotypes (C).
Figure 4
Figure 4
Comparison of visual and anatomic outcome between age-related macular degeneration (AMD) with and without dry macula at month 4. (A) Prevalence of dry macula, SRF, and IRF at baseline and month 4. (B and C) Changes in central retinal thickness (CRT) (B), and logarithm of minimum angle resolution (logMAR) visual acuity (VA) (C) in age-related macular degeneration (AMD) with and without dry macula at month 4. **P < 0.005, ***P < 0.001 compared between baseline and month 4 (B and C).
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