Lucy Cobbs, MD
Wills Eye Hospital
Thomas Jefferson University Hospital
Dr. Rishi Singh from Cleveland Clinic presented the 12-month results for the DAVIO Trial, which investigated the safety and efficacy of EYP-1901, Vorolanib as a bioerodible Durasert, for treating patients with neovascular age-related macular degeneration (nAMD). Vorolanib is a receptor-binding small molecule tyrosine kinase inhibitor which antagonizes all isoforms of VEGF. EYP-1901 is a novel approach to nAMD therapy, combining vorolanib with a sustained delivery device.
The DAVIO trial was a 12-month multi-center open-label dose escalation study with no control arm in nAMD patients who had been previously treated with anti-VEGF therapy. The study design included a screening visit at which patients were given the standard-of-care anti-VEGF treatment and EYP-1901 within 7-10 days following the randomization. This was a dose escalation study from 440 micrograms up to 3000 micrograms within the trial. The primary endpoint was safety, including ocular and non-ocular adverse events. The secondary endpoints were the change in best corrected visual acuity (BCVA) and central subfield thickness (CST) over time with the need for supplemental anti-VEGF therapy over the course of the study.
Patients had to have a minimum of 3 anti-VEGF treatments in the 6 months prior to entry in the trial. The criteria for administering supplemental anti-VEGF therapy during the study included new or worsening vision-threatening hemorrhage, increase of CST thickness of 75 microns from baseline, or a loss of 10 letters of visual acuity from baseline.
The study results demonstrated an overall favorable safety profile with no evidence of serious adverse events, no retinal vasculitis, no posterior segment inflammation, and no occlusive events. There was a reduction in treatment burden at 12 months, with various levels of reduction seen at dose escalation over the study. The mean BCVA and CST were stable after the single EYP-1901 injection from baseline.
Dr. Singh concluded his presentation, noting that there are several phase 2 clinical trials expected in the upcoming year on EYP-1901 for multiple indications, including nAMD, diabetic retinopathy, and diabetic macular edema.