Clinical Report: Breye Raises €67.5M for Oral DR Therapy
Overview
Breye Therapeutics has secured €67.5 million to advance danegaptide into a Phase II trial for non-proliferative diabetic retinopathy (NPDR). This funding will support the development of danegaptide.
Background
Diabetic retinopathy is a significant cause of vision loss among individuals with diabetes, and treatment options for early stages, such as NPDR, are limited. Current therapies often require invasive procedures.
Data Highlights
Breye plans to initiate a randomized Phase II study of danegaptide in NPDR patients in 2027. A Phase Ib study completed in 2025 showed that danegaptide was well tolerated and indicated early signs of clinical activity.
Key Findings
- Breye Therapeutics raised €67.5 million in an oversubscribed Series A financing round.
- Danegaptide is an oral small molecule designed to stabilize retinal vasculature.
- The therapy aims to address chronic hyperglycemia effects, such as capillary breakdown and vascular leakage.
- Current treatment options for NPDR are limited, with intravitreal therapies requiring injections.
Clinical Implications
The advancement of danegaptide represents a potential shift in the management of NPDR, offering a non-invasive treatment option. Clinicians may consider the implications of oral therapies in their treatment strategies for diabetic retinopathy.
Conclusion
Breye Therapeutics has secured funding to develop an oral treatment for diabetic retinopathy.
Related Resources & Content
- Breye Therapeutics, Retinal Physician, 2024 -- Breye Raises €67.5M for Oral DR Therapy
- Breye Therapeutics, New Retinal Physician, 2024 -- Breye Therapeutics Initiates Danegaptide Trial
- American Diabetes Association, Diabetes Care, 2026 -- 12. Retinopathy, Neuropathy, and Foot Care: Standards of Care in Diabetes
- JAMA Network, 2024 -- Four-Year Visual Outcomes in the Protocol W Randomized Trial of Intravitreous Aflibercept for Prevention of Vision-Threatening Complications of Diabetic Retinopathy
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- 12. Retinopathy, Neuropathy, and Foot Care: Standards of Care in Diabetes—2026 | Diabetes Care | American Diabetes Association
- Four-Year Visual Outcomes in the Protocol W Randomized Trial of Intravitreous Aflibercept for Prevention of Vision-Threatening Complications of Diabetic Retinopathy | Trials | JAMA | JAMA Network
- Effect of Fenofibrate on Progression of Diabetic Retinopathy | NEJM Evidence
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