Evaluating the effectiveness, durability, and safety of faricimab in patients with diabetic macular edema.

This study evaluated the effectiveness, durability, and safety of faricimab (Vabysmo) for the treatment of patients with diabetic macular edema (DME). The data showed that faricimab with extended dosing up to every 16 weeks was safe and showed good vision gains and clinical improvements in these patients.

Patients with diabetes are at risk of developing an eye disease called diabetic retinopathy (DR). Some patients with DR can develop thickening and swelling of a part of the eye, called diabetic macular edema (DME). DME is a major cause of vision loss in patients with diabetes. DME consists of the accumulation of fluid at the back of the eye (retina). This fluid causes swelling in the central part of the retina (macula).

One type of treatment for DME is anti-VEGF drugs. They are injected into the eye and reduce the swelling to prevent vision loss. The anti-VEGF drugs like aflibercept (Eylea) decrease the formation of new blood vessels in the eye and reduce swelling. Despite the effectiveness of anti-VEGF therapy in clinical trials, optimal treatment outcomes are difficult to achieve and maintain in clinical practice.

Requiring injections every 4–8 weeks and frequent monitoring visits can be burdensome for patients and their doctors. Faricimab is a new bispecific antibody that targets both VEGF and angiopoietin 2. This leads to a stabilization of the blood vessels in the retina. This stops the leakage of fluid. The effectiveness, durability, and safety of faricimab for the treatment of patients with DME are still unknown.

This study involved 2 studies and included a total of 1891 patients with DME. Patients were randomly assigned into 3 groups in both studies. In study 1 (YOSEMITE), group 1 included 315 patients who received faricimab every 8 weeks. Group 2 included 313 patients who received faricimab every 4 weeks up to every 16 weeks (personalized based on DME activity). Group 3 included 312 patients who received aflibercept every 8 weeks. In study 2 (RHINE), group A included 317 patients who received faricimab every 8 weeks. Group B included 319 patients who received faricimab every 4 weeks up to every 16 weeks. Group C included 315 patients who received aflibercept every 8 weeks.

In the YOSEMITE study, the average vision gains from baseline at two years were +10.7 eye chart letters in group 1 and +11.6 eye chart letters in group 2 compared to +10.9 eye chart letters in group 3.

In the RHINE study, the average vision gains from baseline at two years were +11.8 eye chart letters in group A and +10.8 eye chart letters in group B compared to +10.3 eye chart letters in group C.

Important vision gains and anatomical improvements with faricimab were achieved with adjustable dosing up to every 16 weeks.

The frequency of eye side effects was similar between the groups.

This study concluded that faricimab with extended dosing up to every 16 weeks was safe and showed important vision gains and anatomical improvements in patients with DME.

The follow-up period was short, of 1 year. A longer follow-up is needed to confirm these results. This study was funded by F Hoffman-La Roche, the manufacturer of faricimab.