Merck presents one-year results on a novel DME treatment at AAO 2026
Merck presented one-year results from a pivotal trial evaluating remigromig, a tri-specific agent targeting a pathway involved in retinal eye disease, in adults with diabetic macular edema (DME). The study compared remigromig with ranibizumab, a standard anti-VEGF therapy, and found non-inferiority in improving visual acuity after one year. The findings may influence future treatment options for people with DME, a condition that can threaten vision in diabetes. No regulatory approvals are reported here; the results are early-phase, though they are described as pivotal for guiding next steps in research and development.
What the study tested and what was found
The BRUNELLO trial examined remigromig (also called MK-3000), an investigational biologic with a novel mechanism designed to engage three targets in the Wingless-related integration site pathway. In adults with DME, the study compared remigromig to the standard anti-VEGF therapy ranibizumab over roughly one year. The main finding reported is non-inferiority in mean change from baseline in best-c corrected visual acuity (BCVA) at one year, meaning remigromig performed about as well as ranibizumab in preserving or improving vision. The press release notes remigromig as potentially the first biologic with this new mechanism to show non-inferiority in a pivotal DME trial. The data are described as being presented for the first time at AAO 2026.
Key facts for readers
- Remigromig is an investigational, tri-specific agent targeting a pathway called the Wingless-related integration site (Wnt) pathway, which is involved in cellular signaling in the retina.
- The trial compared remigromig with ranibizumab over one year in adults with diabetic macular edema.
- The primary note reported is non-inferiority in visual acuity improvements at one year compared with ranibizumab.
- Remigromig is not yet approved by regulators based on the information provided; results are from a pivotal trial used to support future development decisions.
- Persistent DME remains common despite current therapies, underscoring the potential value of new approaches if proven safe and effective in larger trials.
Who is affected and what it means for care
Adults with diabetic macular edema were the study participants. DME is a complication of diabetes that can cause vision loss if untreated or not adequately managed. Treatments currently rely on anti-VEGF injections; a non-inferiority result suggests remigromig could become an alternative option if approved, potentially offering different dosing schedules or side-effect profiles. At this stage, the information is from a single trial and does not indicate real-world accessibility or payer coverage.
Practical next steps for patients and clinicians
- Monitor for regulatory updates: await formal regulatory review and potential approval timelines before considering use outside trials.
- Discuss ongoing treatment plans with a clinician if you or a loved one has DME, especially if current therapy is suboptimal or burdensome; do not change treatment without medical advice.
- Consider trial participation: pivotal trials can offer access to investigational therapies under rigorous monitoring.
- Stay informed about long-term safety and real-world effectiveness data that typically accompany broader development and possible approvals.
Limits of the information and open questions
What the one-year results show is non-inferiority to an existing therapy in a specific trial population. Details about safety, long-term outcomes, dosing, and comparative advantages remain to be disclosed in full scientific publications and regulatory submissions. It is not yet known how remigromig would fit into standard practice, how often injections would be required, or how costs would compare to current treatments.
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