Merck's Remigromig Meets Vision Endpoint in Diabetic Macular Edema Trial
Pharmaceutical giant Merck & Co., Inc. (NYSEMRK) announced on Thursday that its experimental eye drug remigromig met the noninferiority goal against ranibizumab in a pivotal trial for diabetic macular edema.
The Sept. 24 release of the BRUNELLO study results revealed that both doses of remigromig (0.5 mg and 0.8 mg) showed no significant difference in vision improvement compared to the active control, ranibizumab. However, Merck did not disclose the mean gain in vision chart letters for either dose or for the control group.
The study involved 984 adults with diabetic macular edema, who received intravitreal injections of remigromig or ranibizumab every four weeks during the first year. The primary measure was mean change from baseline in best-corrected visual acuity at Week 52, measured on a standard eye chart.
While Merck's shares closed at $148.08 on Wednesday, before Thursday's announcement, no p value or confidence interval was reported by the company. However, Dean Y. Li, President of Merck Research Laboratories, stated that 'we look forward to advancing remigromig in diabetic macular edema, a leading cause of vision loss for people with diabetes, with the hope of offering a new treatment option with the first novel mechanism of action for retinal vascular diseases in more than two decades.'