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Merck Presents One-Year Results from the Pivotal Phase 2b/3 BRUNELLO Study Evaluating Remigromig, a Tri-specific Agonist of the Wingless-related Integration Site (Wnt) Pathway, in Adults with Diabetic Macular Edema at AAO 2026

Business Wire•10/10/2026•18:10 ET
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Key Highlights

  • ➤Remigromig 0.5 mg gained 9.1 BCVA letters versus ranibizumab’s 11.8 at Year 1
  • ➤Remigromig met non-inferiority endpoint in both dose arms versus monthly ranibizumab
  • ➤PDR-related adverse events reached 6.7% and 6.1% versus 0.9% with ranibizumab
  • ➤Treatment discontinuations due to adverse events reached 4.9% and 4.5% versus 0.9%
  • ➤BRUNELLO enrolled 984 participants; results will be discussed with regulators

Expert Statements

Donald J. D’Amico, Chair of Ophthalmology at Weill Cornell Medicine, Ophthalmologist-in-Chief at New York-Presbyterian Hospital and presenting author of the BRUNELLO study

“Although anti-VEGF therapies remain the foundation of treatment for diabetic macular edema, up to two thirds of patients fail to achieve clinically meaningful vision gains after one year, underscoring the need to explore new biological pathways”

David Guyer, Founder, chief executive officer and president of EyeBio, a wholly owned subsidiary of Merck

“Despite important advances in care, up to 40% of patients with diabetic macular edema have persistent disease activity after six months of treatment, meaning that they do not respond or only partially respond to therapy, underscoring the need for new therapeutic approaches”

David Guyer, Founder, chief executive officer and president of EyeBio, a wholly owned subsidiary of Merck

“The BRUNELLO study provides important evidence that activating the Wnt pathway, which is involved in the repair and maintenance of the blood-retinal barrier, may offer a potential new way to help patients with DME and expand treatment options for retinal specialists and their patients.”

Dean Y. Li, President, Merck Research Laboratories

“The BRUNELLO results represent an important milestone for people living with diabetic macular edema, a leading cause of vision loss among people living with diabetes, which impacts nearly 1.6 million people in the U.S.”

Dean Y. Li, President, Merck Research Laboratories

“As the first new mechanism of action in more than 20 years to demonstrate non-inferior visual acuity compared with standard-of-care anti-VEGF therapy in a pivotal DME study, remigromig has the potential to expand treatment options for retinal specialists and patients.”

Merck Presents One-Year Results from the Pivotal Phase 2b/3 BRUNELLO Study Evaluating Remigromig, a Tri-specific Agonist of the Wingless-related Integration Site (Wnt) Pathway, in Adults with Diabetic Macular Edema at AAO 2026

Remigromig demonstrated non-inferiority in mean change from baseline in best corrected visual acuity versus ranibizumab at one year in patients with diabetic macular edema (DME)

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