Merck sees pivotal victory for $3B eye disease prospect

Key Points:

• Merck’s Brunello trial for remigromig, a trispecific diabetic macular edema (DME) drug, met its primary endpoint by demonstrating noninferiority to ranibizumab (Lucentis) on visual acuity improvement at Week 52.
• Remigromig, which targets the Wnt signaling pathway to restore blood-retinal barrier integrity, was generally well tolerated but showed higher rates of proliferative diabetic retinopathy, vitreous hemorrhage, and treatment discontinuations compared to ranibizumab.
• Merck plans to present detailed trial data at the upcoming American Academy of Ophthalmology Annual Meeting and will engage regulatory authorities, with a second similar phase 2b/3 trial ongoing and expected to complete primary data collection in March.
• The drug aims to address the 30-40% of DME patients who do not respond or stop responding to existing VEGF inhibitors, with Merck positioning remigromig as part of a potential combination treatment strategy alongside VEGF drugs.
• Remigromig and a related Tie2xVEGF bispecific, MK-8748, were acquired by Merck in a $1.3 billion upfront deal for EyeBio in 2024, supporting Merck’s strategy to diversify beyond its key oncology drug Keytruda amid patent expirations.