Danegaptide Shows Promise in Early Diabetic Retinopathy Treatment

New research suggests that danegaptide, an oral medication, may offer a novel treatment approach for nonproliferative diabetic retinopathy (NPDR), potentially allowing for intervention at earlier stages of the disease. A phase 1b study presented at Angiogenesis, Exudation, and Degeneration 2026 demonstrated positive biological effects and a favorable safety profile.

What is Diabetic Retinopathy?

Diabetic retinopathy is a common complication of diabetes, affecting the blood vessels in the retina. It’s a leading cause of blindness globally. The National Eye Institute details the progression from mild NPDR to more severe forms, including proliferative diabetic retinopathy, which requires more aggressive treatment. Early detection and management are crucial to prevent vision loss.

Study Findings: Danegaptide’s Impact

The phase 1b study, conducted across the U.K., Germany, and the U.S., involved 24 adults (mean age 64; 25% female) with NPDR and diabetic macular edema. Participants received oral danegaptide once or twice daily for 28 days, followed by a 14-day follow-up period. Twenty-two patients were included in the final analysis.

Key findings include:

• Safety: No clinical safety signals were observed during the study period. Plasma levels of danegaptide remained within the targeted range.
• Vascular Leakage Reduction: 55% of patients exhibited signs of reduced vascular leakage, as assessed by fluorescein angiography. This indicates a decrease in fluid leaking from blood vessels in the retina.
• Macular Exudation Reduction: A similar proportion of patients showed reduced macular exudation, evidenced by decreased macular thickness, macular volume, and fewer intraretinal cysts on high-definition OCT scans. Macular exudation refers to the buildup of fluid in the macula, the central part of the retina responsible for sharp, central vision.

How Does Danegaptide Work?

Danegaptide is a novel peptide that modulates the activity of the angiopoietin-2 (Ang-2) pathway. Breye Therapeutics, the developer of danegaptide, explains that Ang-2 plays a critical role in vascular destabilization and inflammation, both key factors in the development of diabetic retinopathy. By targeting this pathway, danegaptide aims to stabilize blood vessels and reduce leakage.

Potential for Earlier Intervention

Carl D. Regillo, MD, director of the retina service at Wills Eye Hospital and a member of Breye’s scientific advisory board, highlighted the potential of danegaptide to treat diabetic retinopathy at earlier stages. “This would create new options for how diabetic retinopathy is treated — opening the door to halting or even reversing disease and treating it before the risk emerges of disease progression to advanced forms,” he stated in a press release.

What’s Next?

Breye Therapeutics is currently fundraising for a phase 2 randomized clinical trial to further evaluate the efficacy and safety of danegaptide in a larger patient population. The completion of the phase 1b trial was announced in June 2025. The company anticipates that positive results from future trials could lead to a new oral treatment option for diabetic retinopathy, potentially improving outcomes for millions of people with diabetes.

Key Takeaways

• Danegaptide demonstrates promising biological activity in patients with nonproliferative diabetic retinopathy.
• The phase 1b study showed a favorable safety profile.
• Danegaptide may allow for earlier intervention in diabetic retinopathy, potentially preventing vision loss.
• A phase 2 clinical trial is planned to further evaluate the drug’s efficacy.

Disclaimer: This article provides general information and should not be considered medical advice. Always consult with a qualified healthcare professional for diagnosis and treatment of any medical condition.