Merck has begun the pivotal Phase 2b/3 MALBEC study of MK‑8748, a bispecific antibody that activates Tie2 signaling while inhibiting VEGF, for the treatment of neovascular age‑related macular degeneration (NVAMD). The trial will compare MK‑8748 to the current standard of care, aflibercept, and will evaluate mean change in best‑corrected visual acuity as its primary endpoint.
The launch of this study marks a key step in Merck’s expanding ophthalmology strategy, which was accelerated by the acquisition of EyeBio for up to $3 billion in May 2024. EyeBio’s lead candidate, Restoret (EYE103), and MK‑8748 together broaden Merck’s portfolio in a high‑growth, high‑barrier market that can help offset the impending Keytruda patent cliff expected in 2028‑2029. Merck’s existing ophthalmology assets include Winrevair, which generated $280 million in sales in Q1 2025, and Capvaxive, a 21‑valent pneumococcal conjugate vaccine for adults.
The MALBEC trial is a large, diverse, Phase 2b/3 study that is expected to provide regulatory data within the next few years. While the exact completion date is not disclosed, the design and endpoints are aligned with FDA expectations for a potential approval pathway. The trial’s dual‑mechanism approach—simultaneous Tie2 activation and VEGF inhibition—aims to address unmet needs in patients who do not fully respond to anti‑VEGF monotherapy and to reduce injection frequency.
Merck’s Q1 2025 worldwide sales totaled $15.5 billion, with Keytruda contributing $7.2 billion and Winrevair $280 million. The company maintained its full‑year 2025 sales guidance of $64.1 billion to $65.6 billion, reflecting confidence in its diversified pipeline. The investment in the MK‑8748 program is part of a broader strategy to generate new revenue streams as Keytruda’s exclusivity period winds down.
The initiation of the MALBEC study signals Merck’s commitment to building a robust ophthalmology pipeline that could become a significant contributor to future earnings. While the trial’s success remains uncertain, the potential for a dual‑mechanism therapy to improve efficacy and reduce treatment burden positions MK‑8748 as a promising candidate in a competitive market dominated by anti‑VEGF agents.
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