Faricimab Safe, Effective for Use in Treating nAMD in Treatment-Naive Eyes

A new study published in Clinical & Experimental Ophthalmology found that faricimab was effective in treating patients with neovascular age-related macular degeneration (nAMD) who had not previously been treated. Lesion activity in nAMD also responded better with faricimab compared with the 2-mg dose of aflibercept.

Faricimab is a vascular endothelial growth factor (VEGF) inhibitor that targets VEGF-A and angiopoietin-2 to treat nAMD, otherwise known as dry AMD. Faricimab has previously been shown to improve visual acuity outcomes in patients with nAMD in a way that was not inferior to aflibercept 2 mg.2 These results primarily came from phase 3 trials, necessitating more data on real-world outcomes. This study aimed to measure visual acuity outcomes, safety profiles, and lesion inactivation rates in a real-world data set of patients who were living with nAMD and were treatment naive prior to the study. These results were compared against outcomes in eyes treated with aflibercept 2 mg.1

Faricimab was effective in treatment-naive eyes for treating nAMD | Image credit: RFBSIP - stock.adobe.com

The study primarily used data from Australia through the Fight Retinal Blindness! registry. All data from this registry are observational. Patients are systematically tracked at each visit through the registry, and demographic data were collected at the time of the first intravitreal injection. Visual acuity was measured at each visit. Physicians were asked to grade the activity of neovascularization into inactive, subretinal fluid (SRF) only, or active groups. The treatment administered was also recorded.

All included eyes were treatment naive and began treatment with faricimab between January 2023 and September 2024. Eyes were included if they were aged 50 years and older, had at least 1 follow-up visit after the first injection, and had a visual acuity measure available at the first injection. The follow-up time was 12 months in all participants. Participants were recorded as having completed treatment if they had any visits after 12 months. Participants were defined as staying on the medication if they continued to use faricimab during the observation period; patients who were defined as having switched off did so prior to the end of the observation period.

In the comparison group, participants were included if they started aflibercept 2 mg between 2017 and 2021 so as to reduce selection bias, as faricimab would not have been available for patients at that time.

There were 160 eyes eligible for this study; 35% of the 142 patients were men, and the mean age was 81.5 years at first injection. The mean crude visual acuity improved by 4.0 letters over the course of 12 months. The mean number of injections was 7.2, and the mean number of visits was 7.4, both within 12 months. A total of 48% of the eyes achieved a dosing interval of 12 weeks or more, but 22% were being treated more frequently than the 8-weekly minimum.

A total of 6.9% of the eyes switched off of faricimab after a mean of 24 weeks. Their mean visual acuity improved by 5.1 letters at the time of switch-off. A total of 15% of the eyes did not complete the 12-month follow-up, with those who completed the follow-up being younger (80.8 vs 85.8 years) and having a better baseline visual acuity (63.2 vs 52.2 letters) compared with those who did not complete it.

More eyes became inactive after being treated with faricimab at 12 months compared with aflibercept (71% vs 62%); faricimab also led to more patients being inactive at least once over the 12 months (90% vs 85%). Mean visual acuity gain was slightly higher in those who used faricimab (+4.0 vs +3.7 letters). Last injection intervals were slightly longer in those taking faricimab (median, 11.0 vs 9.3 weeks).

There were some limitations to this study. It had a smaller sample size, which could limit its generalizability. Selection bias is possible due to the observational design of the study. The follow-up period was also relatively short and prevents analysis of long-term outcomes.

“Our findings support the use of faricimab in routine clinical practice, highlighting its efficacy and durability with no significant safety signal,” the authors concluded. “Ongoing observational studies will be essential to establish what precisely the additional benefits are that second-generation VEGF inhibitors offer our nAMD patients.”

References

1. Gillies M, Hashimoto Y, Nazari R, et al. Twelve-month real-world outcomes of faricimab for treatment-naïve neovascular AMD in Australia. Clin Exp Ophthalmol. Published online February 8, 2026. doi:10.1111/ceo.70072
2. Bonavitacola J. FDA approves faricimab PFS for leading causes of vision loss. AJMC®. July 8, 2024. Accessed February 11, 2026. https://www.ajmc.com/view/fda-approves-faricimab-pfs-for-leading-causes-of-vision-loss