MSD’s novel diabetic macular oedema (DME) therapy has been proven non-inferior to Roche and Novartis’ marketed anti-VEGF drug, Lucentis (ranibizumab), though early tolerability signals could throw a spanner in the works for the medicine’s potential disruption of the anti-VEGF-dominated market.
In the Phase IIb/III BRUNELLO study (NCT06571045), MSD pitted two different once-four-weekly doses of remigromig against Lucentis, an anti-VEGF therapy commonly used to treat DME, across a cohort of 984 adults.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
During the trial, both the 0.5mg and 0.8mg doses of remigromig, previously known as EYE103, offered a non-inferior change in the clarity and sharpness of vision versus Lucentis – meeting the trial’s primary endpoint.
According to David Guyer, CEO and president of the drug’s original developer, EyeBio, this makes remigromig the “first and only new mechanism of action” in two decades that has achieved non-inferior late-stage results to that of the anti-VEGF class.
However, BRUNELLO investigators did observe higher rates of treatment-related adverse events (TRAEs) such as bleeding inside the vitreous and proliferative diabetic retinopathy – an affliction where abnormal new blood vessels grow in the eye. While MSD is yet to share specifics on the drug’s safety and tolerability profile, the pharma giant did note that there were more TRAE-linked discontinuations in the remigromig arms versus the Lucentis treatment group. MSD plans to characterise these findings through further analyses.
Despite running into some potential tolerability roadblocks, remigromig could represent a notable step forward for patients with DME, as researchers estimate that around four in 10 patients do not fully respond to marketed treatments like Lucentis or Bayer and Regeneron’s flagship therapy Eylea (aflibercept).
William Blair analysts note that the BRUNELLO study provides significant further validation of the Wnt agonism mechanism in DME.
If remigromig were to make it to market, it could become the first therapy to target the Wingless-related integration site (Wnt) signalling pathway, which contributes to tissue repair and the renewal of cells in the eye.
MSD, known as Merck & Co. in the US, acquired the rights to remigromig through its $3bn takeover of EyeBio in 2024.
Wnt agonism approach catches the industry’s eye
While MSD is currently one of the frontrunners in the race to bring a Wnt agonist to the DME market, California-based biotech Surrozen is also looking to take its multispecific Wnt-focused antibody, SZN-8141, to the clinic by the end of 2026. Unlike remigromig, SZN-8141 combines its agonistic activity on Frizzled-4 (FZD4), a Wnt protein receptor, with VEGF antagonism – potentially approaching treatment from multiple angles.
According to William Blair analysts, Surrozen’s Wnt-focused pipeline could “represent blockbuster opportunities given the potential for differentiated efficacy”.
According to a recent report from GlobalData, parent company of Clinical Trials Arena, the DME market was worth $4.42bn across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, Japan) in 2024. Analysts predict that the segment will balloon at a compound annual growth rate (CAGR) of 3.4% between 2024 and 2034.
