Merck’s DME Drug Candidate Meets Phase 3 Efficacy Goal, but Safety Concerns Remain

Merck said its candidate treatment for diabetic macular edema, remigromig, met the noninferiority criterion for vision improvement in a late-stage clinical trial.

Merck confirmed efficacy in the BRUNELLO trial, which compared the candidate with Roche’s Lucentis, but said it will conduct further analyses because rates of proliferative diabetic retinopathy, intraocular hemorrhage and treatment discontinuation were high.

Merck acquired the candidate when it bought iBio for $1.3 billion (about 1.74 trillion won) two years ago. The company plans to present the full first-year results at a conference on Oct. 10.