Merck and EyeBio Start Phase 2b/3 Trial for Restoret™ to Treat Diabetic Macular Edema

Merck, identified as MSD outside the U.S. and Canada, along with its subsidiary EyeBio, has initiated the Phase 2b/3 BRUNELLO trial for evaluating Restoret™ (MK-3000, formerly EYE103) in treating diabetic macular edema (DME). MK-3000 is a novel, investigational tetravalent tri-specific antibody that targets the Wingless-related integration site (Wnt) signaling pathway. The decision to commence the BRUNELLO trial is supported by data from the Phase 1/2 AMARONE study, which involved patients with DME and neovascular age-related macular degeneration (NVAMD).

The AMARONE study's early results provided promising evidence for MK-3000's potential benefits for patients with retinal diseases. Dr. David Guyer, founder, CEO, and president of EyeBio, emphasized the significance of the BRUNELLO trial as an important milestone in collaboration with Merck to offer new treatments for patients with DME.

The BRUNELLO trial is a randomized, double-masked Phase 2b/3 study assessing the safety and efficacy of two dosages of intravitreal (IVT) Restoret (MK-3000) against the active control, ranibizumab, in DME patients. Participants will be randomly assigned to receive either low or high doses of MK-3000 or ranibizumab every four weeks for the first year. In the second year, treatment frequency will be adjusted based on a personalized treatment interval (PTI) algorithm. The primary endpoints of the trial are safety and the mean change in best-corrected visual acuity (BCVA) from baseline to week 52, using standardized Early Treatment Diabetic Retinopathy Study (ETDRS) vision measurements.

Diabetic macular edema (DME) is a serious condition that can lead to vision impairment and blindness if not treated. It affects around 750,000 individuals in the United States. DME occurs when damaged blood vessels leak into the retina, causing swelling in the macula, which is essential for sharp vision. The prevalence of DME is expected to increase alongside the rising incidence of diabetes.

Restoret (MK-3000, formerly EYE103) is a pioneering investigational Wnt antibody designed to address the unmet medical needs of patients with retinal diseases like DME and NVAMD. Administered through intravitreal injection, MK-3000 aims to stop vascular leakage in retinal diseases by activating the Wnt pathway, thereby restoring and maintaining the blood-retinal barrier. Preclinical studies suggest that activating the Wnt pathway in the retina could reduce vascular leakage.

Merck, known as MSD outside the United States and Canada, has been dedicated to using cutting-edge science to save and improve lives globally for more than 130 years. The company strives to be a leader in research-intensive biopharmaceuticals, focusing on developing innovative health solutions to prevent and treat diseases in both humans and animals. Merck fosters a diverse and inclusive workforce and operates responsibly to ensure a safe, sustainable, and healthy future for all communities.

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