Talk Bio

Prof. Carl D. Regillo presented Phase 1b trial data for danegaptide in 24 patients with non-proliferative diabetic retinopathy (NPDR) and macular edema at the Angiogenesis, Exudation and Degeneration 2026 symposium on February 7, 2026. 1 2 The oral treatment was well-tolerated, achieved targeted plasma levels, and showed retinal imaging data consistent with reductions in vascular leakage in more than half of patients, with statistically significant reductions in edema measures after 4 weeks. 1 2 Danegaptide is a first-in-class oral small molecule that stabilizes vasculature and protects against retinal capillary breakdown caused by hyperglycemia. 1 2 The data support advancing to a Phase 2 randomized trial assessing improvements in Diabetic Retinopathy Severity Scale (DRSS) scores; Breye is preparing and fundraising for this. 1 2 3 Sources: 1. https://www.globenewswire.com/news-release/2026/02/09/3234282/0/en/Strong-clinical-data-for-Breye-Therapeutics-lead-oral-asset-danegap...