Merck (MRK) announced the initiation of a pivotal Phase 2b/3 trial evaluating MK-8748, a novel investigational bispecific antibody that directly activates Tie2 signaling and inhibits vascular endothelial growth factor, for the treatment of neovascular age-related macular degeneration. The study, known as MALBEC, is the first trial of a broader late-phase development program for MK-8748, with a second study in NVAMD scheduled to begin this year. The decision to advance into pivotal studies is based on results from the Phase 1/2a RIOJA trial, a two-part study evaluating MK-8748 in patients with either NVAMD, macular edema secondary to branch retinal vein occlusion or diabetic macular edema.
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