Merck's Remigromig Shows Positive Results in Diabetic Macular Edema Trial

Merck & Co. has unveiled positive topline results from the pivotal phase 2b/3 BRUNELLO trial evaluating its investigational drug Remigromig (MK-3000, formerly EYE103) for diabetic macular edema (DME). Remigromig is a tetravalent, tri-specific antibody designed to activate the Wnt pathway, which plays a role in repairing and maintaining the blood-retinal barrier while increasing vascular endothelial growth factor (VEGF) levels in retinal diseases.

The trial compared two dose levels of Remigromig (0.5 mg and 0.8 mg) against the active control ranibizumab 0.5 mg in 984 participants with DME. At 52 weeks, both doses of Remigromig demonstrated non-inferiority to ranibizumab in improving best-corrected visual acuity (BCVA). The drug was generally well tolerated, though higher rates of proliferative diabetic retinopathy (PDR), vitreous hemorrhage, and treatment discontinuations due to adverse events were observed in the Remigromig arms.

David Guyer, MD, founder, CEO, and president of EyeBio, emphasized the significance of these results, stating that Remigromig represents the first new mechanism of action in 20 years to achieve phase 3 results non-inferior to anti-VEGF therapy. Merck plans to present additional data from the BRUNELLO trial at the American Academy of Ophthalmology (AAO) annual meeting's Retina Subspecialty Day on Saturday, Oct. 10.

Merck also has another ophthalmic candidate, MK-8748 (Tiespectus), in its pipeline for wet age-related macular degeneration (AMD) and DME. Tiespectus is a novel bispecific antibody that activates the Tie2 pathway and inhibits VEGF, aiming to stabilize retinal and choroidal blood vessels.