Oxurion NV announced that the first patient has been dosed in its Phase 2 clinical study evaluating THR-687 in patients with Diabetic Macular Edema (DME) (study name “INTEGRAL”). The INTEGRAL study is a Phase 2, randomized, multicenter trial and is the first study in which multiple intravitreal injections of THR-687 will be administered in humans. The two-part study will assess two dose levels of multiple THR-687 injections (Part A) and, if successful, go on to evaluate the efficacy and safety of THR-687 versus aflibercept (the current standard of care) for the treatment of DME (Part B). Part A is being conducted in treatment naïve subjects to select the optimal THR-687 dose level to be assessed in Part B. Part B will be conducted in both treatment naïve and treatment experienced subjects to evaluate the efficacy and safety of THR-687 compared to aflibercept. The primary efficacy endpoint of the study in Part B is the change in Best Corrected Visual Acuity (BCVA) from baseline at Month 3. The dose selection decision, following Part A, is anticipated in the first half of 2022 with top line data from Part B expected in the second half of 2023. Oxurion has already generated positive data from a Phase 1, open-label, multicenter (US), single dose escalation study evaluating the safety of a single intravitreal injection of 3 dose levels (0.4 mg, 1.0 mg, 2.5 mg) of THR-687 for the treatment of DME. A single injection of THR-687 was safe and well-tolerated, showing a very encouraging efficacy signal. 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. The mean BCVA improvement was maintained with 8.3 letters gain at Month 3 following a single injection of THR-687. A 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. Beyond DME, THR-687 has the potential to be developed for additional vascular retinal disorders including for wet Age-related Macular Degeneration (wet AMD) and Retinal Vein Occlusion (RVO).