Merck and EyeBio announce initiation of phase 2b/3 BRUNELLO trial evaluating MK-3000 for treatment of diabetic macular edema

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Merck and EyeBio have announced the initiation of the phase 2b/3 BRUNELLO trial (NCT06571045) evaluating MK-3000 (Restoret, formerly EYE103) for the treatment of diabetic macular edema (DME).

The BRUNELLO trial is a randomized, double-masked trial evaluating the efficacy and safety of 2 dose levels of intravitreal MK-3000 versus active control ranibizumab in patients with DME.

Patients will be randomized 1:1:1 to receive low and high-dose regimens of MK-3000 or ranibizumab every 4 weeks for the first year. In the second year, the frequency of treatment for participants will shift based on a personalized treatment interval algorithm. Dual primary endpoints for the trial are safety and mean change in best-corrected visual acuity (BCVA) from baseline to week 52 in the study eye of the participants, using standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) vision.¹

MK-3000 is an investigational, potentially first-in-class tetravalent, tri-specific Wnt antibody and is administered as an intravitreal injection to eliminate vascular leakage in retinal diseases by agonizing the Wnt pathway with the goal of restoring and maintaining the blood-retinal barrier.¹

The initiation of the BRUNELLO trial is based on results from the open-label, Phase 1/2 AMARONE study of MK-3000 in patients with DME and neovascular age-related macular degeneration (nAMD).¹

David Guyer, MD, founder and CEO of EyeBio discussed the initiation of the BRUNELLO trial in a press release from Merck and EyeBio stating, “Data from the Phase 1/2 AMARONE study provided early evidence for the potential of MK-3000 for patients with retinal disease. 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.”

This past July, Merck completed the acquisition of EyeBio, making it a wholly-owned subsidiary of Merck. The deal was valued as high as $3 billion, including an upfont cash payment of $1.3 billion, along with the potential for an additional $1.7 billion in developmental, regulatory, and commercial milestone payments.

References:

1. Merck and EyeBio Announce Initiation of Phase 2b/3 Clinical Trial for Restoret™ for the Treatment of Diabetic Macular Edema. Press Release; September 4, 2024. Accessed September 5, 2024. https://www.merck.com/news/merck-and-eyebio-announce-initiation-of-phase-2b-3-clinical-trial-for-restoret-for-the-treatment-of-diabetic-macular-edema/