Merck advances EyeBio’s Remigromig in US trial for diabetic macular edema
Merck plans to present the BRUNELLO results at the American Academy of Ophthalmology Annual Meeting in New Orleans on October 10 and discuss the findings with regulatory authorities.
USA—Merck & Co. has reported positive topline results from its BRUNELLO trial, showing that remigromig met the primary endpoint in adults with diabetic macular edema (DME) by matching ranibizumab on a measure of visual acuity after 52 weeks.
The result supports continued development of the experimental treatment, which Merck acquired through its 2024 purchase of EyeBio.
Trial results and safety findings
BRUNELLO is a pivotal Phase 2b/3 study comparing two doses of remigromig, 0.5 mg and 0.8 mg, with 0.5 mg ranibizumab, sold as Lucentis in the US by Roche’s Genentech.
According to Merck, both remigromig doses were noninferior to ranibizumab for the mean change from baseline in best-corrected visual acuity at Week 52.
Remigromig is an investigational tetravalent, trispecific antibody designed to activate the Wnt signaling pathway.
Merck says the pathway helps repair and maintain the blood-retinal barrier, which can become compromised in retinal vascular diseases such as DME.
The drug was previously known as EYE103 and Restoret during EyeBio’s development programme.
Merck also reported that remigromig was generally well tolerated.
However, patients receiving either dose had higher rates of proliferative diabetic retinopathy, vitreous haemorrhage and treatment discontinuations because of adverse events than those receiving ranibizumab.
The company said further analyses are underway to better characterise these findings.
Competitive position in DME
The findings are significant for Merck because remigromig uses a mechanism different from established anti-VEGF therapies.
At a Wells Fargo investor event in September, Merck Research Laboratories President Dean Li said the company estimates that 30% to 40% of patients with DME either do not respond to existing VEGF treatments or eventually stop responding.
Li also said Merck expects ophthalmologists could combine VEGF and non-VEGF treatments as treatment options expand.
The DME market already includes several anti-VEGF medicines, including ranibizumab, aflibercept, and faricimab, increasing the importance of clinical differentiation for newer therapies.
Merck’s EyeBio investment
Merck acquired EyeBio in 2024 for an upfront payment of US$1.3 billion, with up to US$1.7 billion in additional development, regulatory, and commercial milestone payments, bringing the potential transaction value to US$3 billion.
The deal gave Merck remigromig and other retinal disease programmes as the company expanded its ophthalmology pipeline.
Merck plans to present the BRUNELLO results at the American Academy of Ophthalmology Annual Meeting in New Orleans on October 10 and discuss the findings with regulatory authorities.
A second Phase 2b/3 study, BAROLO, is also evaluating remigromig in DME, while the company is studying the drug in other retinal conditions.
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