Oxurion NV reported positive topline data from a Phase 1 study with THR-687, a novel, potent, pan-RGD integrin antagonist for the treatment of Diabetic Macular Edema (DME). The Phase 1, open-label, multi-center (US), single dose escalation study evaluated the safety of a single intravitreal injection of 3 increasing doses (0.4 mg, 1.0 mg, 2.5 mg) of THR-687 for the treatment of DME (NCT03666923). Patients recruited into the study had a history of response to prior anti-VEGF and/or corticosteroid treatment. At baseline, the study patient population had a mean BCVA of 56 letters, and a mean Central Subfield Thickness (CST) of 542µm. Topline data from the trial show that THR-687 is well-tolerated and safe with no dose-limiting toxicities. No serious adverse events were reported at any of the doses evaluated in the study. The study also looked at efficacy including changes to the patient’s BCVA. Across all doses, a rapid onset of action in mean BCVA was observed from Day 1 with an increase of 3.1 letters, which further improved to 9.2 letters at Month 1. This activity was maintained with a mean BCVA improvement of 8.3 letters at Month 3 following a single injection of THR-687. A clear dose response was seen with the greatest positive effect on BCVA and Central Subfield Thickness (CST) with the highest dose of THR-687. For this highest dose, a mean BCVA Improvement of 11 letters was noted at Day 14, with a peak improvement of 12.5 letters at Month 3. Similarly, a peak mean CST decrease of 106 µm was observed at Day 14 with the highest dose of THR-687. The company is currently preparing the complete data analysis from this Phase 1 study with THR-687 and plans to present further clinical data at the Angiogenesis, Exudation, and Degeneration 2020 Meeting on 8th February in Miami, Florida. THR-687 is the second VEGF-independent clinical candidate under development for diabetic eye disease by Oxurion. THR-149, the Company’s other and most advanced VEGF-independent treatment also delivered positive Phase 1 results in July 2019.