Merck drug remigromig meets primary goal in Phase 2b/3 study

Merck announced topline results on September 24, 2026, from the pivotal Phase 2b/3 BRUNELLO trial evaluating remigromig in adults with diabetic macular edema (DME). Both the 0.5 mg and 0.8 mg doses met the primary endpoint at week 52 by demonstrating non-inferiority to the active control, 0.5 mg ranibizumab, in mean change from baseline in best-corrected visual acuity.

The trial enrolled 984 participants randomised across three treatment arms. Both remigromig doses were generally well tolerated, although higher rates of proliferative diabetic retinopathy, vitreous hemorrhage, and treatment discontinuations due to adverse events occurred compared with ranibizumab. Further analyses remain underway to examine these events.

Remigromig is a tri-specific antibody designed to activate the Wnt pathway to repair the blood-retinal barrier. Merck is also testing the therapy in the ongoing Phase 2b/3 BAROLO study for DME and a Phase 2 trial for other retinal conditions. The company plans to present the one-year BRUNELLO data at the American Academy of Ophthalmology Annual Meeting on October 10, 2026.