EyePoint initiates Duravyu program, announces preclinical vorolanib data

EyePoint (EYPT) announced details for its pivotal Phase 3 program evaluating Duravyu for the treatment of diabetic macular edema with first patient dosing anticipated in first quarter of 2026. The company also shared new preclinical data that demonstrates vorolanib, the active drug in Duravyu, inhibits interleukin-6 mediated inflammation through inhibition of all Janus Kinase receptors, in particular JAK-1, in addition to known blockage of vascular endothelial growth factor mediated vascular permeability. This finding reinforces the early and sustained improvements observed through six months in the Phase 2 VERONA clinical trial and positions Duravyu as a potential multi-mechanism of action treatment. New data demonstrates that Duravyu has the potential to be a multi-MOA treatment, inhibiting both VEGF via inhibition of all VEGFRs and IL-6 signaling via JAK receptor blockage. IL-6 is a pro-inflammatory cytokine that has been observed at significantly higher levels in patients with DME and wet AMD compared to healthy individuals. IL-6 signaling occurs via activation of the JAK kinases, particularly JAK-1, leading to vascular leakage and inflammation that together compound damage to the blood-retinal barrier in DME. Vorolanib is a potent and selective tyrosine kinase inhibitor that inhibits all VEGF and JAK receptors, particularly JAK-1, with new in vitro data showing a reduction in IL-6 activity of more than 50% potentially bringing a synergistic anti-inflammatory effect in addition to established VEGF inhibition. Furthermore, Duravyu features sustained drug delivery providing consistent daily dosing with receptor inhibition for at least six months after a single injection. The positive efficacy results from the Phase 2 VERONA trial, where a single DURAVYU 2.7mg dose demonstrated early and meaningful improvements in vision and anatomy compared to aflibercept, further underscore the potential clinical utility in DME. The company will be presenting the preclinical data on JAK/IL-6 inhibition at the Eyecelerator meeting at AAO 2025.