Merck and EyeBio Announce Initiation of Phase 2b/3 Clinical Trial for Restoret™ for the Treatment of Diabetic Macular Edema
September 04 2024 - 5:40AM
Business Wire
Merck (NYSE: MRK), known as MSD outside of the United States and
Canada, and EyeBio, a wholly-owned subsidiary of Merck & Co.,
Inc., Rahway, N.J., USA, today 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.”
About the BRUNELLO trial 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. For further
information about the BRUNELLO trial, please visit
www.clinicaltrials.gov.
About 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.
About Restoret Restoret (MK-3000, formerly EYE103) is an
investigational, potentially first-in-class tetravalent,
tri-specific Wnt antibody designed to address unmet medical need in
patients with retinal diseases, including diabetic macular edema
(DME) and neovascular age-related macular degeneration (NVAMD).
MK-3000 is administered as an 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. Preclinical evidence indicates that
agonizing the Wnt pathway in the retina may reduce vascular
leakage.
About Merck At Merck, known as MSD outside of the United
States and Canada, we are unified around our purpose: We use the
power of leading-edge science to save and improve lives around the
world. For more than 130 years, we have brought hope to humanity
through the development of important medicines and vaccines. We
aspire to be the premier research-intensive biopharmaceutical
company in the world - and today, we are at the forefront of
research to deliver innovative health solutions that advance the
prevention and treatment of diseases in people and animals. We
foster a diverse and inclusive global workforce and operate
responsibly every day to enable a safe, sustainable and healthy
future for all people and communities. For more information, visit
www.merck.com and connect with us on X (formerly Twitter),
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Forward-Looking Statement of Merck & Co., Inc., Rahway,
N.J., USA This news release of Merck & Co., Inc., Rahway,
N.J., USA (the “company”) includes “forward-looking statements”
within the meaning of the safe harbor provisions of the U.S.
Private Securities Litigation Reform Act of 1995. These statements
are based upon the current beliefs and expectations of the
company’s management and are subject to significant risks and
uncertainties. There can be no guarantees with respect to pipeline
candidates that the candidates will receive the necessary
regulatory approvals or that they will prove to be commercially
successful. If underlying assumptions prove inaccurate or risks or
uncertainties materialize, actual results may differ materially
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forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s Annual
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