Merck announced on September 24, 2026 that its investigational antibody remigromig met the non‑inferiority goal in the pivotal BRUNELLO trial for diabetic macular edema. The study enrolled 984 patients with DME who were randomized 1:1:1 to receive either 0.5 mg remigromig, 0.8 mg remigromig, or 0.5 mg ranibizumab every four weeks, with a personalized dosing algorithm scheduled for the second year.
At 52 weeks, both remigromig doses met the pre‑specified non‑inferiority criterion for mean change from baseline in best‑corrected visual acuity when compared with ranibizumab. Merck noted that the antibody was generally well tolerated, but higher rates of proliferative diabetic retinopathy, vitreous hemorrhage, and treatment discontinuations due to adverse events were observed in the remigromig arms.
The company plans to present the year‑one results at the American Academy of Ophthalmology Annual Meeting in New Orleans on October 10 and will discuss the findings with regulatory authorities. Additional ongoing research includes the BAROLO Phase 2b/3 study in DME and a Phase 2 proof‑of‑concept trial in neovascular age‑related macular degeneration and retinal vein occlusion.
Diabetic macular edema affects an estimated 1.6 million people in the United States and remains a leading cause of vision loss among individuals with diabetes.
