AMD updates from ARVO: treatment burden, ongoing assessment of vorolanib intravitreal insert
Ramiro Ribeiro, MD, PhD, of Eyepoint Pharmaceuticals, discussed the design of the LUGANO and LUCIA trials, which were presented at the ARVO 2025 meeting.
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 ARVO this year, we’re going to be presenting our clinical development program in wet AMD. We’re first presenting our DAVIO 2 study, which is the largest phase 2 study using TKI in wet AMD.
We are presenting new data on a post-hoc analysis, assessing the treatment burden for patients that enroll in that study. We show that patients that were in the Duravyu arm, our investigational product, had a lower reduction in the treatment burden compared to patients on the aflibercept arm while maintaining the same visual acuity gains throughout the study. That’s, of course, very exciting and we had that phase 2 study. Now the other poster we’re presenting at ARVO is the design of our phase 3 clinical program, the LUGANO and the LUCIA studies.
In that study, we are enrolling both treatment-naive patients as well as previously treated. We have 2 arms, a Duravyu arm and aflibercept 2 mg as a control. For that study, every single patient gets 3 loading doses of aflibercept in the beginning of the study, and then at week 8 they get aflibercept plus Duravyu. Then on the aflibercept arm, aflibercept plus sham. The primary endpoint for that study is the change in best corrected visual acuity from baseline to average week 52 and 56.
We assess the primary endpoint at 1 year, but the studies are designed to last for 2 years for safety follow-up assessment.
It is a very exciting time for EyePoint. Those studies are currently enrolling and going ahead of schedule. Being able to present the study design at ARVO, it’s going to be something that we’re looking forward with the retina community.
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