News|Articles|November 11, 2026

VERONA: Katherine Talcott, MD, on early gains with a TKI insert in DME

Author(s)Katherine Talcott, MD, Kassi Filkins, Martin David Harp

Diabetic macular edema (DME) remains a leading cause of vision loss in working-age adults, and many patients need frequent anti-VEGF injections to keep fluid under control. The vorolanib intravitreal insert (EYP-1901; Duravyu; EyePoint), an investigational bioerodible insert that releases the tyrosine kinase inhibitor (TKI) vorolanib for approximately 6 months, is being studied as a way to reduce that burden.

At the 26th EURETINA Congress in Vienna, Austria, results from the phase 2 VERONA trial (NCT06099184) were presented. VERONA randomized 27 patients with previously treated DME to a single injection of aflibercept 2 mg plus EYP-1901 2.7 mg (n = 11), EYP-1901 1.3 mg (n = 10) or sham (n = 6), with monthly assessment for supplemental treatment through week 24. The trial met its primary end point of extended time to first supplemental injection: 73% and 60% of patients in the 2.7-mg and 1.3-mg arms, respectively, remained supplement-free through week 24, compared with 50% of patients receiving aflibercept alone. Improvements in best-corrected visual acuity (BCVA) and central subfield thickness (CST) were seen as early as week 4, although mean BCVA gains at week 24 were similar across arms. Greater reductions in macular leakage area (−3.1 and −2.0 vs −0.7 mm²) and total macular volume (−0.60 and −0.37 vs −0.16 mm³) were also reported with both insert doses at week 24.

COMO (NCT07449936) and CAPRI (NCT07449923), two phase 3 noninferiority trials that together enrolled 551 patients, are comparing the 2.7-mg insert every 6 months with aflibercept 2 mg every 8 weeks, with topline data expected in the fourth quarter of 2027. EyePoint is now prioritizing the DME program after both of its phase 3 trials in neovascular age-related macular degeneration, LUGANO and LUCIA, missed their noninferiority primary end points.

Modern Retina spoke with Katherine E. Talcott, MD, a vitreoretinal specialist at the Cole Eye Institute, Cleveland Clinic, in Cleveland, Ohio, who presented the VERONA findings at EURETINA. In the following Q&A, Talcott discusses how vorolanib differs from anti-VEGF therapy, the VERONA design, the efficacy and safety findings, the early visual and anatomic response that surprised her and the phase 3 COMO and CAPRI program.

This Q&A has been lightly edited for length and clarity.

Modern Retina (MR): What is EYP-1901, and how does it differ from current anti-VEGF therapy?

Katherine E. Talcott, MD: So the VERONA study is a phase 2 study looking at patients who have diabetic macular edema. EYP-1901 is a tyrosine kinase inhibitor, so it's a small molecule that doesn't just impact the VEGF signaling pathway, but also PDGFR as well as IL-6–mediated inflammation, and it's an intravitreal insert that's designed to last approximately 6 months.

MR: How was the phase 2 VERONA trial designed?

Talcott: So the phase 2 VERONA study looked at previously treated patients with DME. So at baseline, everyone got aflibercept 2 mg at the same time. People were randomized to get sham, EYP-1901 1.3 mg or EYP-1901 2.7 mg. They were followed for 6 months. Starting at month 1, they were able to get supplemental treatment if they met prespecified criteria.

MR: What were the key efficacy findings?

Talcott: So overall, in the phase 2 VERONA study, the primary end point was met, which is that patients who were treated with EYP-1901 in addition to aflibercept 2 mg needed less supplementation, or their time to supplementation was lower than if they didn't receive it. So there was a significant difference in the number of patients who were able to go supplement free if they got EYP-1901 versus [sham].

If we broke it down by vision and then by CST, the vision improved in the EYP-1901 groups to a greater extent, even 1 month following the initial injection, suggesting that the drug is available early and was able to maintain those visual acuity gains over 6 months. Similarly, there was an improvement of CST. First signal was at just a month after the initial injection, and that was maintained over 6 months.

The other thing that was shown is that EYP-1901 had a significant impact in terms of macular leakage as well as macular volume, which are important mediators and biomarkers in diabetic macular edema.

MR: What did the safety data show?

Talcott: Of course, to all of us as retina specialists, safety is top of mind. There were no significant safety signals in the trial. There were no cases of intraocular inflammation, vasculitis or endophthalmitis, and no patients discontinued treatment because of the experimental drugs.

MR: What surprised you most about the results?

Talcott: I think the thing that surprised me the most is that there was a difference in terms of the vision and the OCT just starting at 1 month following the initial injection. I would have expected, just based on the mechanism of TKIs, just decreased burden, but it actually looked like those patients who were treated with both actually got improved vision and had better anatomy than the patients who just got aflibercept. I think this is a promising signal for TKIs in this space, that TKIs will be able to hopefully help reduce treatment burden for these patients.

MR: What comes next, and what could this mean for patients?

Talcott: So overall, I think these results are really exciting. They're going to be further analyzed in the phase 3 pivotal studies, COMO and CAPRI, which are both fully enrolled, and we expect results in the fourth quarter of 2027. But I think the reason that this can be helpful potentially for patients is because it's able to maintain good visual acuity gains and improvement of their anatomy, but with a decreased treatment frequency and treatment burden.