Merck Advances Bispecific Antibody MK-8748 Into Late-Stage Wet AMD Studies

Merck announced the initiation of a pivotal Phase 2b/3 trial, MALBEC, to evaluate MK-8748 (Tiespectus/EYE201), a novel bispecific antibody for the treatment of neovascular (wet) age-related macular degeneration (NVAMD). The therapy is designed to both activate Tie2 signalling and inhibit VEGF, targeting key pathways involved in retinal disease.

The MALBEC study marks the first late-stage trial in a broader development program for MK-8748, with an additional NVAMD study planned later this year. The advancement to pivotal trials follows encouraging results from the earlier Phase 1/2a RIOJA study, which assessed the therapy across multiple retinal conditions, including NVAMD, diabetic macular edema, and macular edema related to retinal vein occlusion.

“Despite available therapies, many patients with neovascular age-related macular degeneration remain at risk of further vision loss due to continued vascular leakage,” said Dr. David Guyer, founder, chief executive officer and president, EyeBio, a wholly-owned subsidiary of Merck & Co., Inc., Rahway, N.J., USA. “With its differentiated dual mechanism directly agonizing Tie2 and inhibiting VEGF, MK-8748 has the potential to offer a novel approach to maintain vascular stability for patients with serious retinal diseases.”

Merck continues to expand its ophthalmology pipeline, focusing on diseases driven by vascular leakage and abnormal blood vessel growth. These include NVAMD, diabetic macular edema, and retinal vein occlusion-related conditions, all of which represent significant unmet medical needs.

Alongside MK-8748, the company is also developing MK-3000 (Restoret/EYE103), a next-generation antibody targeting the Wnt signaling pathway. This candidate is currently being evaluated in ongoing Phase 2b/3 studies for diabetic macular edema, further strengthening Merck’s late-stage ophthalmology portfolio.

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Merck Advances Bispecific Antibody MK-8748 Into Late-Stage Wet AMD Studies