Merck reported positive topline results from the pivotal Phase 2b/3 BRUNELLO study for remigromig. This investigational treatment targets diabetic macular edema (DME), a leading cause of vision loss in diabetic patients.
The drug met its primary endpoint by demonstrating non-inferiority to the standard treatment, ranibizumab. These vision improvement results were measured after 52 weeks of treatment.
Remigromig functions as a first-in-class antibody that activates the Wnt pathway to maintain the blood-retinal barrier. While the drug was generally well-tolerated, Merck noted higher rates of proliferative diabetic retinopathy and vitreous hemorrhage compared to the control group.
These specific adverse events require further analysis. Merck will discuss the findings with regulatory authorities and present detailed results at the American Academy of Ophthalmology meeting in October.