pp-210 Tablets

Indication: Diabetic macular oedema (DME) — oral systemic therapy Clinical stage: Phase 2 — Phase 2a completed (positive); Phase 2b/3 strategy via FDA Type C meeting (planned 2025) Modality: Small molecule (vascular endothelial junction stabiliser via SIRT1 pathway) Mechanism / Target: Selectively stabilises endothelial cell-to-cell junctions in retinal vasculature via SIRT1 (sirtuin-1) pathway activation; reduces retinal vascular leakage in DME without anti-VEGF mechanism; addresses both inflammatory and metabolic drivers of DME Route / form: Oral tablet (once or twice daily) Differentiation: First potential oral treatment for DME; entirely novel mechanism vs. intravitreal anti-VEGF injections (aflibercept, ranibizumab); Phase 2a positive (67 patients, 3 months, US); major patient benefit — eliminates need for repeated eye injections; FDA regulatory strategy via Type C meeting; Thea Open Innovation = Phase 2 support for separate eye drop formulation;