Ramiro Ribeiro, MD, PhD, of Eyepoint Pharmaceuticals, speaks about data presented at the Retina World Congress that showed positive outcomes with Duravyu for patients with diabetic macular edema (DME).
Ramiro Ribeiro, MD, PhD:
My name is Ramiro Ribeiro. I’m the Chief Medical Officer at EyePoint and I’m responsible for the clinical studies that we’re conducting for wet AMD indication as well as DME.
At the Retina World Congress this year we are presenting for the first time, our VERONA study 24-week results. To recap, the VERONA trial was a study designed to assess the efficacy of the review in patients with DME. In that study we enrolled patients with active DME, so they had CST greater than 325 microns. We dosed everybody with aflibercept at day 1 and then they get either Duravyu high-dose, Duravyu low-dose, or the control arm was aflibercept plus sham. Those patients were followed on a monthly basis and the primary endpoint was at week 24, and it was the time to first anti-VEGF supplement injection.
What we show in that study was that patients on the review arm had a delay in getting their first treatment with anti-VEGF, resulting in a positive study. But what was very important was that we showed a early gain in BCVA at week 4 throughout week 12, which was also seeing a reduction in CST. The CST results mirror what we saw in the BCVA results. Very important for the VERONA trial in terms of safety, continues to be excellent with the same safety profile of Duravyu that we saw in other studies. We are now discussing the plans for our DME indication with regulatory agencies and planning for future steps.
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