Merck said remigromig met the primary endpoint in the pivotal Phase 2b/3 BRUNELLO trial in adults with diabetic macular edema (DME).
Both tested doses—0.5 mg and 0.8 mg—were non-inferior to Roche’s ranibizumab at 52 weeks, based on changes in best-corrected visual acuity.
Remigromig is an investigational tri-specific antibody designed to activate the Wnt pathway and help repair the blood-retinal barrier. Merck acquired the program in its $3 billion Eyebiotech takeover.
The result supports remigromig’s potential as the first major new mechanism for retinal vascular diseases in more than two decades, but it does not yet establish commercial success.
Safety remains a concern:
Merck reported higher rates of proliferative diabetic retinopathy, vitreous hemorrhage and treatment discontinuations due to adverse events versus ranibizumab. Further analysis is underway.
A second pivotal DME trial is ongoing, and Merck plans to present fuller results at the American Academy of Ophthalmology meeting next month.
Sources:
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