Clinical Report: Could NPDR Be Treated Orally?
Overview
The phase 1b trial of danegaptide, an oral treatment for non-proliferative diabetic retinopathy (NPDR), demonstrated good safety, tolerability, and early signs of biological activity, including reductions in vascular leakage. This study suggests a potential shift in managing NPDR, addressing an unmet need for less invasive treatment options.
Background
Diabetic retinopathy (DR) is a leading cause of vision loss among patients with diabetes, particularly in its non-proliferative stage. Current treatments primarily involve invasive intravitreal injections, which are burdensome for patients at earlier stages of the disease. The development of an oral therapy like danegaptide could provide a more accessible treatment option, potentially improving patient adherence and outcomes.
Data Highlights
| Parameter | Results |
|---|---|
| Patients | 24 |
| Reduction in vascular leakage | More than half of study eyes |
| Statistically significant reduction in edema scores | Yes |
Key Findings
- Danegaptide is the first oral drug specifically designed for diabetic retinopathy.
- The phase 1b trial met its objectives for safety, tolerability, and pharmacokinetics.
- More than half of the study eyes showed retinal imaging data associated with reduced vascular leakage.
- Participants exhibited statistically significant reductions in edema scores by the end of the study.
- Oral administration may improve patient adherence compared to repeated intravitreal injections.
Clinical Implications
The introduction of danegaptide as an oral therapy could significantly change the management of NPDR, allowing for earlier intervention and reducing the burden of treatment on patients. This approach may also enhance adherence to treatment regimens, potentially improving long-term outcomes.
Conclusion
Danegaptide shows promise as a novel oral treatment for NPDR, addressing significant unmet needs in the management of this condition. Further studies are necessary to confirm these findings and assess the long-term benefits of this therapy.
References
- Carl Regillo, Angiogenesis, Exudation and Degeneration Symposium, 2026 -- Could NPDR Be Treated Orally?
- Journal of Gastroenterology — Pharmacological Approaches for Managing NAFLD and NASH: Present and Future Perspectives
- Bone Marrow Transplantation — Poster Presentations from the Nurses Group at the 47th Annual Conference of the European Society for Blood and Marrow Transplantation (Sessions NP001 – NP028)
- the asco post — Intralesional Nivolumab May Be Effective Against Precancerous Oral Lesions
- Retinal Physician — NPI001 Demonstrates Treatment Effect in RP Trial
- Standards of Care in Diabetes-2026
- Evaluation of Intravitreal Aflibercept for the Treatment of Severe Nonproliferative Diabetic Retinopathy
- Oral therapies for diabetic retinopathy: Addressing an unmet need or a distant prospect? - PMC
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