Merck, in collaboration with its subsidiary EyeBio, has announced the initiation of the Phase 2b/3 BRUNELLO clinical trial to evaluate Restoret™ (MK-3000), a novel therapeutic agent, for the treatment of diabetic macular edema (DME). This pivotal study aims to assess the efficacy and safety of Restoret in improving visual outcomes for patients with DME, a leading cause of vision loss among individuals with diabetes.
The BRUNELLO trial (NCT06571045) is a randomized, double-masked, active-controlled study designed to compare two dose levels of intravitreal Restoret (MK-3000) against ranibizumab, a current standard of care, in patients with DME. Eligible patients will be randomized in a 1:1:1 ratio to receive either low-dose MK-3000, high-dose MK-3000, or ranibizumab administered every four weeks for the first year. In the second year, the frequency of treatment will be adjusted based on a personalized treatment interval (PTI) algorithm.
The dual primary endpoints of the BRUNELLO trial are safety and the mean change in best-corrected visual acuity (BCVA) from baseline to week 52, as measured by standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) vision testing. The trial seeks to enroll a diverse patient population to ensure broad applicability of the findings.
Restoret (MK-3000): A Novel Approach to DME Treatment
Restoret (MK-3000, formerly EYE103) is an investigational, potentially first-in-class tetravalent, tri-specific antibody. It is designed to agonize the Wingless-related integration site (Wnt) signaling pathway. Preclinical evidence suggests that agonizing the Wnt pathway in the retina may reduce vascular leakage, a key factor in the development of DME.
MK-3000 is administered via intravitreal injection, seeking to eliminate vascular leakage in retinal diseases by agonizing the Wnt pathway with the goal of restoring and maintaining the blood-retinal barrier.
Clinical Context and Unmet Needs
Diabetic macular edema (DME) is a serious retinal condition affecting an estimated 750,000 people in the United States. It occurs when damaged blood vessels leak into the retina, causing swelling in the macula, the central region of the retina responsible for sharp, detailed vision. If left untreated, DME can lead to blindness and a reduced quality of life.
"Data from the Phase 1/2 AMARONE study provided early evidence for the potential of MK-3000 for patients with retinal disease," said Dr. David Guyer, founder, chief executive officer and president of EyeBio. "The initiation of the BRUNELLO trial marks an important milestone as we work with our new colleagues at Merck, driven by the common purpose to deliver new, much needed options for patients with diabetic macular edema."
About EyeBio
EyeBio is a wholly-owned subsidiary of Merck & Co., Inc., focused on developing and commercializing novel therapies for the treatment of retinal diseases. EyeBio's mission is to deliver innovative solutions that address unmet medical needs and improve the lives of patients with vision-threatening conditions.
