A large retrospective study indicates that patients with neovascular age-related macular degeneration (nAMD) treated with faricimab experienced improved or stabilized visual acuity and a decrease in retina central subfield thickness (CST) during their first year of treatment. The study also suggested that many patients were able to extend the interval between faricimab injections while maintaining disease control.
Faricimab, a bispecific monoclonal antibody, targets both vascular endothelial growth factor (VEGF) and angiopoietin-2, stabilizing blood vessels and reducing leakage and inflammation. This dual mechanism of action theoretically enhances its efficacy compared to anti-VEGF-only alternatives and reduces the risk of systemic exposure and inflammation.
Large-Scale Real-World Data
The real-world retrospective study, led by David Tabano MD, analyzed electronic medical records of over 19,000 eyes from nearly 16,000 nAMD patients treated with faricimab injections for at least 12 months. The cohort included approximately 15,000 patients previously treated for nAMD with other anti-VEGF agents and about 1,100 treatment-naïve patients. Data was sourced from the American Academy of Ophthalmology’s Intelligent Research in Sight (IRIS) registry, encompassing data on over 75 million unique ophthalmic patients seen by 16,000 clinicians across the US.
All patients had at least 12 months of medical record data prior to faricimab treatment, including at least two measurements of visual acuity and two CST measurements for a CST subgroup. At the time of first faricimab treatment, about 42% of treatment-naïve eyes and 52% of previously treated eyes had best documented visual acuity (BDVA) of 20/40 or better. Previously treated eyes received about seven injections at approximately 45-day intervals in the 12 months before switching to faricimab; two-thirds had previously used aflibercept.
Positive Visual and Anatomical Outcomes
The study revealed that mean BDVA improved slightly for treatment-naïve patients, increasing by nearly 3 letters after five faricimab injections. Previously treated patients showed stable visual acuity, with a loss of only 0.3 lines after five treatments. According to Dr. Tabano, these findings align with other studies demonstrating early visual acuity improvement followed by preservation during treatment.
Treatment-naïve eyes also exhibited a more pronounced improvement in CST, steadily decreasing from a mean of 311.0 μm at baseline to 262.1 μm after four injections. In comparison, previously treated eyes showed a decrease from a mean CST of 295.3 μm to 272.6 μm after four treatments, building upon any reduction achieved with prior treatments. Notably, nearly two-thirds of treatment-naïve eyes and over one-third of previously treated eyes experienced a CST reduction of 10% or more following faricimab initiation.
Furthermore, the percentage of eyes with uncontrolled nAMD decreased after faricimab initiation, dropping from 46% to 17% after four injections in treatment-naïve eyes and from 38% to 29% in previously treated eyes.
Reduced Injection Frequency
After the first 6 months of faricimab treatment, fewer injections were required to control nAMD. The mean number of injections decreased from 4.0 to 2.4 in the second 6 months for treatment-naïve eyes and from 4.3 to 3.2 in previously treated eyes. Treatment-naïve eyes demonstrated comparable injection frequency over 12 months to the Tenaya and Lucerne phase III clinical trials for faricimab. This suggests that physicians may be comfortable extending treatment intervals based on early anatomical response, although the rationale for extending intervals is not explicitly documented in the electronic records, according to Dr. Tabano.
Dr. Tabano concluded that the results indicate real-world effectiveness and durability of faricimab treatment, which could effectively increase system capacity to treat nAMD.
