Clinical-stage ophthalmology biotechnology company EyeBio has announced first dosing of participants with an investigational treatment for neovascular age-related macular degeneration (nAMD) and diabetic macular oedema (DMO).
The Phase 1b/2 AMARONE trial is evaluating the safety and preliminary efficacy of intravitreal Restoret (EYE103). The first participants dosed in the multi-centre trial are from Arizona in the United States.
The trial plans to enrol up to 92 participants, who will receive 12-week regimens of Restoret. EyeBio Chief Scientific Officer Dr Tony Adamis said Restoret has the “potential to address a major unmet need in these diseases (nAMD and DMO), namely excess fluid in the retina”.
“Anti-VEGF registrational trials and real-world data both show that excess fluid leads to poorer vision, and the longer that fluid resides in the retina, the less opportunity there is to recover vision. Improved drying of the retina is the clearest opportunity for improvement in patients’ outcomes. Restoret addresses a new biology, which is critical if we want to deliver results beyond those seen with anti-VEGF alone.”
The company’s Chief Medical Officer, Dr Jonathan Prenner said, “More than 60% of patients have suboptimal outcomes and more than 30% have active disease despite treatment with anti-VEGF agents.
“Restoret may present an opportunity to break through the efficacy ceiling we have reached with anti-VEGF standard of care.”
Restoret is an intravitreally delivered, tri-specific antibody that acts as an agonist of the Wnt signalling pathway.