Merck, known as MSD outside of the United States and Canada, and EyeBio have initiated the Phase 2b/3 BRUNELLO trial to investigate Restoret (MK-3000) for diabetic macular edema (DME). The Wnt signaling pathway, a critical target in retinal diseases, is activated by MK-3000, a first-in-class tetravalent, tri-specific antibody that was previously known as EYE103. The BRUNELLO trial is in line with the optimistic results of the Phase 1/2 AMARONE study, which assessed MK-3000 in patients with DME and neovascular age-related macular degeneration (NVAMD).
Dr. David Guyer, CEO of EyeBio, remarked, "Data from the Phase 1/2 AMARONE study provided early evidence for the potential of MK-3000 for patients with retinal disease." A randomized, double-masked study, the BRUNELLO trial compares two dose levels of Restoret (MK-3000) with ranibizumab, an established treatment for DME. The study will enroll patients with DME, a severe retinal condition that impacts vision and quality of life and is becoming increasingly concerning as a result of the increasing prevalence of diabetes. Restoret has the potential to address the unmet medical requirements of patients with retinal diseases such as DME and NVAMD. Merck is dedicated to utilizing science to enhance patient outcomes on a global scale.
