Merck reports Phase 2b/3 trial results for remigromig

Merck presented one-year results on October 10, 2026, from the pivotal Phase 2b/3 BRUNELLO trial evaluating remigromig in adults with diabetic macular edema. The trial enrolled 984 participants across three arms, testing two dosage levels of intravitreal remigromig against monthly 0.5 mg ranibizumab. The presentation took place at the American Academy of Ophthalmology 2026 Annual Meeting in New Orleans.

Both dose arms of remigromig met the primary endpoint of non-inferiority in best corrected visual acuity compared with ranibizumab at one year. Patients receiving 0.5 mg remigromig achieved a mean gain of 9.1 letters, while those on 0.8 mg gained 8.7 letters. Participants treated with ranibizumab gained a mean of 11.8 letters. Merck reported that differences between groups fell within the prespecified non-inferiority margin, while no secondary endpoints showed superiority over ranibizumab.

Adverse events related to proliferative diabetic retinopathy occurred in 6.7% of participants on remigromig 0.5 mg and 6.1% on remigromig 0.8 mg, compared with 0.9% for ranibizumab. Discontinuation rates due to adverse events reached 4.9% and 4.5% in the respective remigromig groups, versus 0.9% in the active control arm. Merck noted these events were generally manageable with standard care and that additional analyses are underway.

Merck plans to discuss the BRUNELLO trial data with regulatory authorities. Remigromig, which activates the Wnt pathway to support the blood-retinal barrier, is also undergoing evaluation in the Phase 2b/3 BAROLO study for diabetic macular edema and the Phase 2 SUPER TUSCAN trial for additional retinal conditions.