Dosing begins in phase 1b/2 trial of Restoret for wet AMD, DME
Click Here to Manage Email Alerts
Key takeaways:
- Up to 92 patients will undergo a 12-week regimen of Restoret.
- The primary outcomes are safety and mean change in best corrected visual acuity from baseline to week 12.
Patient dosing is underway in a phase 1b/2 clinical trial of Restoret for the treatment of diabetic macular edema and neovascular age-related macular degeneration, according to a press release from EyeBio.
Restoret (EYE103) is an intravitreally delivered antibody that acts as an agonist of the Wnt signaling pathway, the release said. It is designed to resolve residual fluid in the retina and improve visual acuity in wet AMD, DME and other retinal diseases of permeability.
Image: Adobe Stock
The AMARONE trial will evaluate the safety and preliminary efficacy of the investigational treatment in up to 92 patients who will receive 12-week regimens of Restoret. The primary endpoints are safety and mean change in best corrected visual acuity from baseline to week 12 in the study eye.
“Restoret has the potential to address a major unmet need in these diseases, namely excess fluid in the retina,” Anthony P. Adamis, MD, chief scientific officer of EyeBio, said in the release. “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.”
Read more about
Click Here to Manage Email Alerts