Danegaptide Shows Promise in Diabetic Retinopathy – Phase 1b Trial Results

Promising early results from a phase 1b clinical trial suggest a potential new avenue for treating diabetic retinopathy. Researchers found that oral administration of the drug danegaptide led to biological changes in over half of patients with nonproliferative diabetic retinopathy, specifically reducing vascular leakage and macular exudation. Importantly, the study, presented at Angiogenesis, Exudation, and Degeneration 2026, showed no concerning safety signals.

Understanding Diabetic Retinopathy and Danegaptide

Diabetic retinopathy is a common complication of diabetes, affecting the blood vessels in the retina. Nonproliferative diabetic retinopathy is an early stage of the disease. The study focused on adults with this condition, also experiencing diabetic macular edema. Danegaptide, developed by Breye Therapeutics, is being investigated as a potential oral treatment, offering a less invasive approach compared to current therapies.

Did You Know? The phase 1b trial involved participants from the U.K., Germany, and the U.S., highlighting an international effort to address this vision-threatening condition.

Study Details and Findings

The trial, led by Carl D. Regillo, MD, of Wills Eye Hospital, involved 24 adults with an average age of 64. Participants received danegaptide orally, either once or twice daily, for 28 days, followed by a 14-day follow-up period. Analysis included data from 22 patients. Researchers used fluorescein angiography and high-definition OCT to assess the drug’s effects. The results indicated that 55% of patients exhibited signs of reduced vascular leakage and/or decreased macular exudation.

Expert Insight: The potential to treat diabetic retinopathy in its earlier stages, as suggested by these findings, could represent a significant shift in how this disease is managed, potentially preventing progression to more severe forms and preserving vision.

What’s Next for Danegaptide?

Breye Therapeutics announced completion of the phase 1b trial in June 2025. The company is currently seeking funding for a phase 2 randomized clinical trial. If successful, this next phase of research could further validate danegaptide’s efficacy and safety, potentially paving the way for a new treatment option for individuals with diabetic retinopathy. Future trials will explore optimal dosages and long-term effects.

Frequently Asked Questions

What was the primary outcome measured in this study?

The primary outcome assessed was the biological effect of danegaptide, specifically looking for signs of reduced vascular leakage and macular exudation using fluorescein angiography and high-definition OCT.

Were there any reported side effects from danegaptide?

No clinical safety signals were observed during the phase 1b trial, indicating that danegaptide was well-tolerated by the participants.

Who presented the study results?

Carl D. Regillo, MD, director of the retina service at Wills Eye Hospital and a member of Breye’s scientific advisory board, presented the findings at Angiogenesis, Exudation, and Degeneration 2026.

As research into danegaptide continues, what impact could a convenient oral treatment option have on patient adherence to diabetic retinopathy management plans?