Merck’s investigational eye disease drug remigromig met the primary endpoint in the Phase 2b/3 BRUNELLO trial, demonstrating non-inferiority to ranibizumab in vision improvement at one year in adults with diabetic macular edema.
Both remigromig doses independently met the endpoint, measured by mean change from baseline in best corrected visual acuity. Patients receiving 0.5 milligrams gained an average of 9.1 letters, while those receiving 0.8 milligrams gained 8.7 letters. Patients receiving monthly ranibizumab at 0.5 milligrams gained 11.8 letters.
The differences fell within the trial’s prespecified non-inferiority margin. No secondary endpoint demonstrated superiority to ranibizumab.
Safety findings included higher rates of adverse events related to proliferative diabetic retinopathy, including new-onset cases, in the remigromig groups. These events occurred in 6.7% of patients receiving 0.5 milligrams and 6.1% receiving 0.8 milligrams, compared with 0.9% receiving ranibizumab.
Treatment discontinuations due to adverse events were also more frequent with remigromig: 4.9% and 4.5% in the respective dose groups, versus 0.9% with ranibizumab.
Merck said additional analyses are underway to characterize these findings. Proliferative diabetic retinopathy cases were generally manageable with standard treatment, according to the company.
Remigromig, also known as MK-3000, is a tri-specific antibody designed to activate the Wnt pathway, which is involved in repairing and maintaining the blood-retinal barrier.
The results were presented at the American Academy of Ophthalmology annual meeting in New Orleans. Merck plans to discuss them with regulators.
Remigromig is also being evaluated in the pivotal BAROLO trial for diabetic macular edema and a Phase 2 study in other retinal diseases.
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