Enzhong Jin, Xiaoying Zhu, Shijie Li, Mingwei Zhao, Heng Miao, Tong Qian
In this short-term real-world study comprising three exploratory disease-specific cohorts of Chinese patients, faricimab was associated with favorable anatomical and functional outcomes and was well tolerated, with the most pronounced benefit in treatment-naïve nAMD eyes. Responses in DME and RVO-ME were more variable and appeared to be influenced by prior treatment history; these subgroup analyses were exploratory, and larger prospective studies are warranted.
OBJECTIVE: To evaluate the real-world efficacy and safety of the bispecific antibody faricimab in Chinese patients with neocascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema secondary to retinal vascular occlusion (RVO-ME).
METHODS: This retrospective, single-center study included 63 patients (74 eyes: 47 nAMD, 19 DME, 8 RVO-ME); no subjects dropped out. Of the 74 eyes, 37.8% were treatment-naïve and 62.2% were treatment-experienced. All eyes received intravitreal faricimab 6 mg in a three-dose loading regimen followed by pro re nata (PRN) retreatment. Best-corrected visual acuity (BCVA, ETDRS letters) and central macular thickness (CMT) were assessed at baseline, 1 month, 3 months, and final follow-up (mean follow-up, 23.9 ± 12.3 weeks). Subgroup analyses by prior treatment status were performed.
RESULTS: Faricimab was associated with anatomical and functional improvements. In nAMD, treatment-naïve patients (n = 17) showed significant BCVA improvement (62.52 ± 5.80 to 71.05 ± 15.68 letters, P = 0.037) and CMT reduction (477.86 ± 189.45 to 324.19 ± 137.62 μm, P = 0.001) at final follow-up. Previously-treated nAMD patients (n = 30) showed only a transient CMT reduction at 3 months (P = 0.022) without sustained visual improvement. After the first injection, intraretinal fluid resolved in 90% of nAMD eyes that had IRF at baseline. After three loading doses, complete resolution of subretinal fluid and pigment epithelial detachment (PED) occurred in 66.7% and 31.3% of eyes, respectively. In DME, treatment-naïve patients (n = 9) achieved early BCVA improvement at 1 month (P = 0.0273) and sustained benefit at final follow-up (P = 0.0180), whereas previously-treated patients (n = 10) showed delayed improvement at 3 months in both BCVA and CMT (P = 0.0117 and 0.0195). In RVO-ME, BCVA improved significantly at 3 months and final follow-up (P = 0.018 and 0.028), whereas CMT showed a nonsignificant decrease. No significant ocular or systemic adverse events were observed.
CONCLUSION: In this short-term real-world study comprising three exploratory disease-specific cohorts of Chinese patients, faricimab was associated with favorable anatomical and functional outcomes and was well tolerated, with the most pronounced benefit in treatment-naïve nAMD eyes. Responses in DME and RVO-ME were more variable and appeared to be influenced by prior treatment history; these subgroup analyses were exploratory, and larger prospective studies are warranted.