\nMerck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first presentation of one-year results from the pivotal Phase 2b\/3 BRUNELLO trial evaluating remigromig (MK-3000, formerly EYE103), an investigational, potentially first-in-class tetravalent, tri-specific antibody designed to activate the Wingless-related integration site (Wnt) pathway, for the treatment of diabetic macular edema (DME). Results were presented today at the American Academy of Ophthalmology (AAO) 2026 Annual Meeting in New Orleans: BRUNELLO – 1-Year Pivotal Trial Results of Remigromig (MK-3000, formerly EYE103) for the Treatment of Diabetic Macular Edema; D. D’Amico.<\/p>\n
\nIn the BRUNELLO study, both remigromig dose arms met the primary endpoint independently, demonstrating non-inferiority in mean change from baseline in best corrected visual acuity (BCVA) at one year compared with monthly 0.5mg ranibizumab. Mean BCVA gains at Year 1 were +9.1 letters (95% CI, 8.1-10.1; p=0.0129, multiplicity-adjusted) with remigromig 0.5 mg and +8.7 letters (95% CI, 7.7-9.8; p=0.0222, multiplicity-adjusted) with remigromig 0.8 mg, compared with +11.8 letters with ranibizumab (95% CI, 10.7-12.8). Differences between treatment groups were within the prespecified non-inferiority margin and were not considered clinically meaningful. No secondary endpoints demonstrated superiority to ranibizumab.<\/p>\n
\nWhile both doses of remigromig were generally well tolerated, adverse events related to proliferative diabetic retinopathy (PDR) occurred more frequently with remigromig than with ranibizumab (6.7% and 6.1% with remigromig 0.5 mg and 0.8 mg, respectively, versus 0.9%), inclusive of new-onset PDR.1<\/sup> In addition, higher rates of treatment discontinuations due to adverse events were observed in the remigromig treatment arms compared with ranibizumab (4.9% and 4.5% with remigromig 0.5 mg and 0.8 mg, respectively, versus 0.9%). Additional analyses are underway to further characterize these findings. PDR rates may reflect natural disease progression in DME patients since remigromig focuses on repair and maintenance of the blood-retinal barrier rather than directly suppressing new vessel growth. PDR cases were generally manageable with standard-of-care treatment.<\/p>\n \n\u201cAlthough anti-VEGF therapies remain the foundation of treatment for diabetic macular edema, up to two thirds of patients fail to achieve clinically meaningful vision gains after one year, underscoring the need to explore new biological pathways,\u201d said Donald J. D\u2019Amico, M.D., chair of Ophthalmology at Weill Cornell Medicine, Ophthalmologist-in-Chief, New York-Presbyterian Hospital and presenting author of the BRUNELLO study. \u201cThese findings \u2012 which demonstrate for the first time that a biologic targeting the Wnt pathway can achieve visual acuity comparable to an established anti-VEGF therapy \u2012 support continued evaluation of this novel approach as we look forward to additional Phase 3 results from the BAROLO study.\u201d<\/p>\n \n\u201cDespite important advances in care, up to 40% of patients with diabetic macular edema have persistent disease activity after six months of treatment, meaning that they do not respond or only partially respond to therapy, underscoring the need for new therapeutic approaches,\u201d said Dr. David Guyer, founder, chief executive officer and president of EyeBio, a wholly owned subsidiary of Merck. \u201cThe BRUNELLO study provides important evidence that activating the Wnt pathway, which is involved in the repair and maintenance of the blood-retinal barrier, may offer a potential new way to help patients with DME and expand treatment options for retinal specialists and their patients.\u201d<\/p>\n \n\u201cThe BRUNELLO results represent an important milestone for people living with diabetic macular edema, a leading cause of vision loss among people living with diabetes, which impacts nearly 1.6 million people in the U.S.,\u201d said Dr. Dean Y. Li, president, Merck Research Laboratories. \u201cAs the first new mechanism of action in more than 20 years to demonstrate non-inferior visual acuity compared with standard-of-care anti-VEGF therapy in a pivotal DME study, remigromig has the potential to expand treatment options for retinal specialists and patients. We thank the patients, caregivers and investigators whose participation made this study possible.\u201d<\/p>\n \nThe BRUNELLO trial data further strengthens Merck\u2019s advancing ophthalmology pipeline, which is aimed at promoting retinal recovery by addressing specific retinal diseases associated with vascular leakage and neovascularization, including DME, neovascular (wet) age-related macular degeneration (NVAMD) and macular edema secondary to retinal vein occlusion (RVO).<\/p>\n \nResults from BRUNELLO will be discussed with regulatory authorities. Remigromig is also being evaluated in the ongoing pivotal Phase 2b\/3 BAROLO study (NCT06957080<\/a>) in patients with DME and in a Phase 2 proof-of-concept study (SUPER TUSCAN) in patients with NVAMD and RVO (NCT07205887<\/a>).<\/p>\n \nThe company is also developing MK-8748 (also known as Tiespectus, EYE201), a novel investigational bispecific antibody with a dual mechanism that directly activates the Tie2 pathway and inhibits VEGF with the goal of stabilizing retinal and choroidal blood vessels and reducing fluid accumulation in the macula. MK-8748 is currently being studied in two pivotal Phase 2b\/3 trials for the treatment of NVAMD, TORRONTES (NCT07496567<\/a>) and MALBEC (NCT07440225<\/a>), and in two pivotal Phase 3 studies for the treatment of DME, SANGIOVESE (NCT07705555<\/a>) and SYRAH (NCT07705607<\/a>).<\/p>\n About the BRUNELLO trial<\/b><\/p>\n \nBRUNELLO is a randomized, double masked pivotal Phase 2b\/3 trial (NCT06571045<\/a>) evaluating the safety and efficacy of two dose levels (0.5 mg and 0.8 mg) of intravitreal (IVT) remigromig (MK-3000, formerly EYE103) versus active control 0.5mg ranibizumab in adults with DME. The trial enrolled 984 participants who were randomized 1:1:1 to receive low and high dose regimens of remigromig 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 primary endpoint is 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 testing. The key secondary endpoints at week 52 are mean change from baseline in BCVA (superiority of remigromig vs. ranibizumab), and mean change from baseline in Central Subfield Thickness (CST) (superiority of remigromig vs. ranibizumab).<\/p>\n About Remigromig<\/b><\/p>\n \nRemigromig (MK-3000, formerly EYE103) is an investigational, potentially first-in-class tetravalent, tri-specific antibody designed to activate the Wingless-related integration site (Wnt) pathway, which is involved in the repair and maintenance of the blood-retinal-barrier. Remigromig is being studied in patients with certain retinal diseases including diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD). Remigromig is administered by intravitreal injection.<\/p>\n About diabetic macular edema<\/b><\/p>\n \nDiabetic macular edema (DME) is a serious retinal condition and a leading cause of vision loss for people with diabetes. An estimated 1.6 million people are living with DME in the United States. DME 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. While currently available treatments have helped to improve outcomes, a significant number of patients, up to 40%, do not respond or only partially respond to therapy, underscoring the need for new treatment approaches.<\/p>\n About Merck<\/b><\/p>\n \nAt 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 \u2013 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<\/a> and connect with us on X (formerly Twitter)<\/a>, Facebook<\/a>, Instagram<\/a>, YouTube<\/a> and LinkedIn<\/a>.<\/p>\n Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA<\/b><\/p>\n \nThis news release of Merck & Co., Inc., Rahway, N.J., USA (the \u201ccompany\u201d) includes \u201cforward-looking statements\u201d 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\u2019s 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 from those set forth in the forward-looking statements.<\/p>\n \nRisks and uncertainties include, but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company\u2019s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company\u2019s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and\/or regulatory actions.<\/p>\n \nThe company undertakes no obligation to publicly update any 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\u2019s Annual Report on Form 10-K for the year ended December 31, 2025 and the company\u2019s other filings with the Securities and Exchange Commission (SEC) available at the SEC\u2019s Internet site (http:\/\/www.sec.gov\/<\/a>).<\/p>\n 1<\/sup> PTs indicative of PDR: diabetic retinopathy (if LLT \u2018proliferative diabetic retinopathy\u2019), vitreous hemorrhage, iris neovascularization, retinal neovascularization, glaucoma (if LLT \u2018neovascular glaucoma\u2019), neovascularization<\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20261010000066\/en\/<\/a><\/span><\/p>\n \nMedia Contacts:<\/p>\n \nElizabeth Sell<\/p>\n
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elizabeth.sell@merck.com
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