Merck’s Remigromig shows non-inferiority at 52 weeks in Phase 2b/3 BRUNELLO study

  • Merck reported 52-week BRUNELLO results for remigromig in adults with diabetic macular edema.
  • Both 0.5 mg and 0.8 mg doses were non-inferior to 0.5 mg ranibizumab.
  • Higher rates of proliferative diabetic retinopathy and vitreous hemorrhage occurred with remigromig.

Merck’s remigromig met the BRUNELLO study’s primary efficacy objective, with both the 0.5 mg and 0.8 mg doses demonstrating non-inferiority to 0.5 mg ranibizumab at 52 weeks in adults with diabetic macular edema. Remigromig, also known as MK-3000 and formerly EYE103, is an investigational tetravalent, tri-specific antibody designed to activate the Wnt pathway, which supports repair and maintenance of the blood-retinal barrier. Diabetic macular edema occurs when diabetes damages retinal blood vessels, causing fluid to leak into and swell the macula, the area responsible for sharp central vision. Both doses were generally well tolerated, although higher rates of proliferative diabetic retinopathy, vitreous hemorrhage and adverse-event-related treatment discontinuations were observed versus ranibizumab. Merck said further analyses are underway. Remigromig is also being studied in the Phase 2b/3 BAROLO trial and the Phase 2 SUPER TUSCAN study, while Merck is advancing the broader ophthalmology pipeline, including MK-8748 in four pivotal trials. Merck shares were up 0.28% at $148.49 at publication, according to Benzinga Pro data.

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