This phase 2 study reports the safety and efficacy of faricimab for diabetic macular edema (DME). Faricimab is a novel bispecific antibody that targets both angiopoietin-2 and VEGF-A.

Study design

The BOULEVARD trial was a prospective, active comparator-controlled, double-masked study that was conducted at 59 sites in the United States. Researchers randomized 168 treatment-naïve patients to receive intravitreal faricimab (6.0 or 1.5 mg) or 0.3 mg ranibizumab and 61 patients previously treated with anti-VEGF to receive 6.0 mg faricimab or 0.3 mg ranibizumab. Patients were dosed monthly for 20 weeks and observed for up to 36 weeks.

Outcomes

Treatment-naïve patients, on average, improved 13.9, 11.7 and 10.3 ETDRS letters from baseline in the 6.0-mg faricimab, 1.5-mg faricimab and ranibizumab groups, respectively. The 3.6-letter difference between the 6.0-mg faricimab and ranibizumab groups was statistically significant (P=0.03). During the observation period, both patient populations experienced dose-dependent reductions in central subfield thickness, improvements in diabetic retinopathy severity scale (DRSS) score improvements and longer time to retreatment during the observation period with faricimab compared with ranibizumab. There were no new or unexpected safety signals.

Limitations

Since this was a phase 2 study, more studies are needed before this treatment can become a standard of care.

Clinical significance

Patients treated with faricimab demonstrated statistically superior visual acuity gains than with ranibizumab at week 24. They exhibited improvements in central subfield thickness, DRSS score and extended durability outcomes. Patients with DME may benefit from simultaneous inhibition of angiopoietin-2 and VEGF-A using faricimab.