ASRS 2025: Phase 2 VERONA study shows durable treatment outcomes with EYP-1901 for DME
Yasha Modi, MD, of NYU Langone Health, gave a presentation at the American Society of Retina Specialists (ASRS) Annual Meeting about the potential to reduce treatment burden with a combination of EYP-1901 plus aflibercept in patients with diabetic macular edema.
Yasha Modi, MD:
At the ASRS 2025 meeting, I had the opportunity to present the VERONA phase 2 study. Now this was a study looking at a tyrosine kinase inhibitor in the setting of diabetic macular edema versus that of aflibercept.
Now, the tyrosine kinase inhibitors have a unique mechanism of action. They effectively block intracellular VEGF receptors. The goal is that there’s sort of these inserts that can last for up to about 6 months in time. From preclinical data, we learned that they’re going to get to the tissues pretty quickly. Even though it has zero-order kinetics, it gets to the tissues very rapidly.
From DAVIO-2, we learned in AMD patients that patients could be extended up to about 6 months, and that’s informed the study design of the LUGANO and the LUCIA study. In diabetic macular edema, the study that I presented was the VERONA phase 2 study, and this was a 3-arm study looking at 2 separate doses of EYP-1901, or Duravyu, given in conjunction with aflibercept, or aflibercept alone. Now, you would argue that patients were then followed monthly, and maybe you would argue that perhaps this seems sort of an obvious study that patients in the aflibercept arm would require more treatment, but effectively they were followed monthly, they had the opportunity to get supplemental treatment, and therefore this effectively functions like a PRN study, with the primary outcome being the time to first supplement of anti-VEGF therapy.
Now, unlike the DAVIO-2 where these patients were really heavily treated, in this particular study these patients had a visual acuity of around 20/50, and their macular edema was present at the time, meaning they were sort of undertreated at the time of the study. When you compare the 2 arms relative to that of aflibercept, the best corrected visual acuity immediately goes up after 1 month compared to that of just aflibercept, and that’s sort of sustained all the way out through 24 weeks. Now, that’s sort of a unique finding because ideally if it’s a zero-order kinetics drug, we really shouldn’t see this bump, but this highlights the unique feature where you have immediate therapeutic impact, where the synergy effectively of both the TKI plus aflibercept had better visual acuities right out of the gate. This was sustained really all the way out through 24 weeks. Now, if you look at the high-dose arm and you say, “What percentage of patients went supplement-free?” That was about 73% relative to that of 50% getting aflibercept.
In the real world, what does this all mean? Well, you have this drug that if they recapitulate these findings in the phase 3 study, which they’re moving forward with, well, now all of a sudden we have a durable treatment that can be used in conjunction with our standard anti-VEGF therapies to hopefully reduce the treatment burden for our patients. We talked about the visual gains kind of right out of the gate; when considering the anatomy of these patients, this effectively mirrors what we see in terms of the visual acuity gains, and that is you have patients with a rapid reduction in their central subfield thickness immediately at four months, and that was greater in the combined EYP-1901 arm and aflibercept relative to those who are just getting aflibercept alone, and that anatomy benefit was persistent out through 24 weeks. This informs our decision-making when we think about a phase 3 study, where the ultimate goal is to sort of see how patients do with every 6-month re-treatment.
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