Merck announced in a press release the initiation of a pivotal phase 2b/3 trial evaluating MK-8748 (also known as Tiespectus, EYE201) for the treatment of neovascular (wet) age-related macular degeneration (NVAMD). MK-8748 is a novel investigational bispecific antibody that directly activates Tie2 signaling and inhibits vascular endothelial growth factor.

The study, known as MALBEC, is the first trial of a broader late-phase development program for MK-8748. A second study in NVAMD is scheduled to begin this year (NCT07496567). The company said the decision to advance into pivotal studies is based on results from the phase 1/2a RIOJA trial (NCT06664502), a 2-part study that evaluated MK-8748 in patients with NVAMD, macular edema secondary to branch retinal vein occlusion, or diabetic macular edema (DME). Merck said it is advancing an ophthalmology pipeline aimed at addressing certain retinal diseases associated with vascular leakage and neovascularization, including NVAMD, DME, and macular edema secondary to retinal vein occlusion.

In addition to MK-8748, the company is developing MK-3000 (also known as Restoret, EYE103), an investigational, potentially first-in-class tetravalent, trispecific antibody that activates the Wingless-related integration site signaling pathway. MK-3000 is being studied in 2 fully enrolled, ongoing registrational phase 2b/3 studies for the treatment of DME. RP