Merck & Co.’s Brunello trial has hit its primary endpoint, shedding light on the effects of a trispecific diabetic macular edema (DME) drug that the Big Pharma bought in a $3 billion takeover.

The phase 2b/3 trial compared Merck's remigromig to ranibizumab, the VEGF inhibitor that Roche’s Genentech sells as Lucentis in the U.S. Mimicking a natural ligand called norrin, remigromig agonizes the Wnt signaling pathway. The pathway supports the restoration and maintenance of blood-retinal barrier integrity, suggesting remigromig could improve visual outcomes.

Merck’s Brunello trial provided support for the hypothesis while leaving questions about remigromig’s commercial prospects unanswered. Both doses of remigromig were noninferior to ranibizumab at Week 52 on the primary endpoint, which looked at change on the best-corrected visual acuity vision test.

Remigromig was well tolerated, Merck said. However, the company reported higher rates of proliferative diabetic retinopathy, vitreous hemorrhage and treatment discontinuations because of adverse events on remigromig than on ranibizumab. Merck is running further analyses to characterize the findings. Eyebiotech, remigromig’s original developer, saw no drug-related adverse events in a phase 1b/2a trial.

Merck will present data from the trial at the American Academy of Ophthalmology Annual Meeting next month. The Big Pharma also plans to discuss the data with regulatory authorities. Another phase 2b/3 trial of remigromig in DME is ongoing and scheduled to reach primary completion in March, according to the federal trials database. Like Brunello, the second trial is comparing remigromig to ranibizumab.

, about whether Merck believed it could show superiority to ranibizumab in the Brunello trial.

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