Merck & Co. Inc. (NYSE: MRK) announced topline results from the pivotal Phase 2b/3 BRUNELLO trial regarding remigromig (MK-3000, formerly EYE103) for the treatment of diabetic macular edema (DME).
The trial evaluated remigromig, a tetravalent, tri-specific antibody designed to activate the Wingless-related integration site (Wnt) pathway, which is involved in repairing and maintaining the blood-retinal barrier. The study focused on adults with DME, a complication where high blood sugar damages retinal blood vessels, causing fluid to leak into the macula and impair vision.
At 52 weeks, both doses of remigromig (0.5 mg and 0.8 mg) demonstrated non-inferiority to the active control, 0.5 mg of Roche Holding AG’s (OTC: RHHBY) Lucentis (ranibizumab), for the mean change from baseline in best-corrected visual acuity (BCVA).
However, the remigromig treatment arms reported higher rates of proliferative diabetic retinopathy (PDR), vitreous hemorrhage, and treatment discontinuations due to adverse events compared to the ranibizumab group. The company noted that both doses of remigromig were generally well tolerated, with further analyses underway.
Merck highlighted that the BRUNELLO results contribute to its advancing ophthalmology pipeline. The company is developing MK-8748 (also known as Tiespectus, EYE201), a bispecific antibody that activates the Tie2 pathway and inhibits VEGF. MK-8748 is currently being studied in pivotal Phase 2b/3 trials for neovascular age-related macular degeneration (NVAMD) and Phase 3 studies for DME.
