RAHWAY, N.J. — September 24, 2026
Merck announced topline results from the pivotal Phase 2b/3 BRUNELLO study evaluating remigromig (MK-3000, formerly EYE103) in adults with diabetic macular edema (DME). Both the 0.5 mg and 0.8 mg doses of the investigational intravitreal therapy demonstrated non-inferiority to 0.5 mg ranibizumab for mean change from baseline in best-corrected visual acuity (BCVA) at Week 52. Merck reported that both doses were generally well tolerated, while higher rates of proliferative diabetic retinopathy, vitreous hemorrhage and treatment discontinuations due to adverse events were observed with remigromig compared with ranibizumab.
Remigromig Demonstrates Non-Inferior Visual Acuity Results
BRUNELLO evaluated two dose levels of remigromig against active-control ranibizumab in adults with DME. At Week 52, both remigromig doses met the primary endpoint of non-inferiority for mean change in BCVA from baseline, based on standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) vision testing. The randomized trial enrolled 984 participants, assigned 1:1:1 to receive 0.5 mg remigromig, 0.8 mg remigromig or 0.5 mg ranibizumab. Participants received treatment every four weeks during the first year, with treatment frequency planned to shift during the second year according to a personalized treatment interval algorithm.
Safety Findings Include Events Requiring Further Analysis
Both remigromig doses were generally well tolerated in the topline analysis. However, Merck reported higher rates of proliferative diabetic retinopathy, vitreous hemorrhage and treatment discontinuations due to adverse events in the remigromig groups compared with ranibizumab. The company said additional analyses are underway to further characterize these findings. Detailed one-year efficacy and safety results are scheduled for presentation at the American Academy of Ophthalmology (AAO) Annual Meeting in New Orleans on October 10, 2026, followed by discussions with regulatory authorities.
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Merck Advances Wnt-Pathway Approach in Retinal Diseases
Remigromig is an investigational tetravalent, tri-specific antibody designed to activate the Wnt pathway, which is involved in repair and maintenance of the blood-retinal barrier. The therapy is being evaluated in DME and other retinal diseases, including neovascular age-related macular degeneration (NVAMD). Merck is also evaluating remigromig in the ongoing Phase 2b/3 BAROLO study in DME and the Phase 2 SUPER TUSCAN study in NVAMD and retinal vein occlusion. The company is developing additional ophthalmology programs, including MK-8748 (Tiespectus/EYE201), a bispecific antibody designed to activate Tie2 and inhibit VEGF.
Source :Merck press release
