By targeting the retina’s protective barrier, oral Danegaptide could help treat diabetic eye damage earlier, though its lasting benefits remain to be tested.
For millions of people with diabetes, treating vision-threatening eye damage means waiting until vision loss has already begun, at which point doctors must deliver regular anti-VEGF injections directly into the eye.
These drugs block a protein involved in blood vessel growth and leakage, but the need for repeated, invasive procedures has made treatment before irreversible damage impractical. Now, researchers have demonstrated that an oral medication called Danegaptide could one day replace or complement those injections.
The new research focuses on non-proliferative diabetic retinopathy, or NPDR, the most common form of diabetes-related damage to the retina, the light-sensitive tissue at the back of the eye. Diabetic retinopathy affects nearly 30% of people living with diabetes, and NPDR accounts for the vast majority of those cases, affecting an estimated tens of millions worldwide. Roughly one-third of adults with diabetes will develop some form of diabetic retinopathy during their lifetime, and the disease remains a leading cause of blindness in working-age adults.
Protecting the retina’s barrier in preclinical models
In a study published September 23, 2026, in the journal Science Translational Medicine, researchers from Trinity College Dublin and Breye Therapeutics tested Danegaptide in preclinical disease models, where its effectiveness was comparable to injectable therapies. Administering the drug rapidly reduced leakage from blood vessels in the retina and reversed retinal swelling, also known as edema. It also prevented breakdown of the inner blood-retina barrier, which regulates what passes from the bloodstream into retinal tissue.
“Managing diabetic eye disease before irreversible damage occurs has long been constrained by the burden of invasive injections,” said Professor Matthew Campbell, chair of neurovascular genetics at Trinity College Dublin and senior author of the research paper.
“Our findings demonstrate that a simple oral pill can effectively target and repair the inner blood-retina barrier. This potentially offers a non-invasive, preventive path forward that could protect vision in both eyes simultaneously, long before severe sight loss takes hold.”
Early retinal improvements, uncertain lasting benefits
In an early Phase Ib clinical trial involving 24 patients with NPDR, oral Danegaptide was safe and well-tolerated, and 55% of participants showed early signs of biological activity. These signs included marked reductions in retinal leakage, decreased central subfield thickness, a measurement of thickness in the central region of the retina, and the disappearance of fluid-filled cysts within retinal tissue.
The human findings provide an initial indication that the drug may act on the retinal changes seen in NPDR, while the comparison with injectable treatments comes from the preclinical models. The research team is calling for larger Phase II trials to assess whether the early results translate into lasting benefits.
Dr. Pete Adamson, chief scientific officer at Breye Therapeutics, added, “The data from this study validate a major paradigm shift in retinal care. By proving that an oral therapy like Danegaptide can directly protect the inner blood-retina barrier, we are opening the door to early, non-invasive intervention for NPDR. The successful Phase Ib results provide a very strong foundation for larger Phase II clinical trials to evaluate long-term efficacy.”
Reference: “Preclinical and clinical evaluation of systemic danegaptide for the treatment of nonproliferative diabetic retinopathy” by Natalie Hudson, Gergő Porkoláb, Jeffrey O’Callaghan, Nicole Hanley, Basma Baccouche, Márk Varró, Ulrik Mouritzen, Benedikte el-Bandak Lind, Peter Adamson and Matthew Campbell, 23 September 2026, Science Translational Medicine.
DOI: 10.1126/scitranslmed.aed8692
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