Merck and its subsidiary EyeBio have announced the initiation of the Phase 2b/3 BRUNELLO clinical trial to evaluate Restoret (MK-3000), an investigational therapy for diabetic macular edema (DME). This follows promising results from the Phase 1/2 AMARONE study, which assessed MK-3000 in patients with DME and neovascular age-related macular degeneration.

Restoret, a tetravalent, tri-specific antibody, targets the Wnt signaling pathway, aiming to reduce retinal vascular leakage. The BRUNELLO trial will compare 2 doses of Restoret to the current treatment standard, ranibizumab, in a randomized, double-masked study. Participants will receive treatments every 4 weeks in the first year, with personalized intervals in the second year. The trial’s primary endpoints are safety and improvements in visual acuity over 52 weeks.