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A new mechanism in 20 years holds its own against the gold standard. Merck's remigromig matched ranibizumab in improving vision for diabetic macular edema patients at 52 weeks in the BRUNELLO trial. However, higher rates of retinal vascular complications raised some safety flags that analysts say need closer scrutiny.
A new mechanism in 20 years holds its own against the gold standard
Merck's investigational eye drug remigromig has hit a major milestone: in the pivotal phase 2b/3 BRUNELLO trial of 984 patients with diabetic macular edema (DME), both low- and high-dose remigromig were noninferior to ranibizumab (Roche's anti-VEGF standard of care) in improving best corrected visual acuity (BCVA) at 52 weeks. If approved, it would be the first drug with a novel mechanism of action for retinal vascular diseases in over two decades.
What makes remigromig different? Rather than blocking blood vessel growth like anti-VEGF agents, it activates the Wnt pathway — a cell growth-regulating system — to help repair the retina's leaky blood-vessel barrier and reduce the swelling that blurs vision in DME patients. Full one-year results will be presented at the American Academy of Ophthalmology (AAO) meeting in October.
By the Numbers
Why it matters: DME is a leading cause of vision loss in people with diabetes, and current treatments have been largely limited to anti-VEGF injections for decades. A new mechanism that matches the standard of care in efficacy — even with safety questions still to be resolved — could meaningfully expand treatment options for millions of patients worldwide.