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  • Merck, EyeBio announce...

Merck, EyeBio announce initiation of Phase 2b/3 clinical trial for Restoret for Diabetic Macular Edema

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-09-08T16:00:47+05:30  |  Updated On 8 Sept 2024 4:01 PM IST
First subjects dosed in Phase-1 clinical trial of Cognitive Disorder drug
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Rahway: Merck, known as MSD outside of the United States and Canada, and EyeBio, a wholly-owned subsidiary of Merck & Co., Inc., Rahway, N.J., USA, have announced the initiation of the Phase 2b/3 BRUNELLO trial evaluating Restoret (MK-3000, formerly EYE103) for the treatment of diabetic macular edema (DME).

MK-3000 is an investigational, potentially first-in-class tetravalent, tri-specific antibody that acts as an agonist of the Wingless-related integration site (Wnt) signaling pathway. 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 (NVAMD).

“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.”

Diabetic macular edema (DME) is a serious retinal condition that poses a risk to vision, potentially leading to blindness and a reduced quality of life if left untreated. DME impacts an estimated 750,000 people in the United States and occurs when damaged blood vessels leak into the retina, resulting in swelling in the macula, the central region of the retina crucial for precise vision necessary for everyday activities. The prevalence of DME is anticipated to rise with the increasing incidence of diabetes.

BRUNELLO is a randomized, double masked Phase 2b/3 trial ( NCT06571045 ) evaluating the efficacy and safety of two dose levels of intravitreal (IVT) Restoret (MK-3000) versus active control ranibizumab in patients with DME. Eligible patients will be randomized 1:1:1 to receive low and high dose regimens of MK-3000 or ranibizumab every four weeks for the first year. In the second year, the frequency of treatment for participants will shift based on a personalized treatment interval (PTI) algorithm. The dual primary endpoints 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.

Read also: Merck Animal Health concludes acquisition of Elanco Aqua business

merckmerck newseyebioeyebio newsRestoretdiabetic macular edema
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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