Merck said its experimental drug remigromig met its primary goal in the Phase 2b/3 BRUNELLO study for diabetic macular edema (DME), a leading cause of vision loss in people with diabetes. After one year, remigromig was not less effective than ranibizumab, the current standard of care, at improving patients’ vision.
The efficacy results came with safety concerns. Proliferative diabetic retinopathy, a serious complication, occurred in 6.1% to 6.7% of patients treated with remigromig, compared with 0.9% of those receiving ranibizumab. More patients in the remigromig groups also discontinued treatment because of side effects.
Merck said it is conducting further analyses of the safety findings and plans to discuss the results with regulators.