An overview of key findings from the phase 2 DAVIO 2 and VERONA clinical trials and updates on phase 3 trials in progress, presented at Retina World Congress 2026.

While current standard-of-care anti-vascular endothelial growth factor (anti-VEGF) therapies have revolutionized the treatment of retinal exudative diseases such as wet age-related macular degeneration (AMD) and diabetic macular edema (DME), core challenges remain, with many patients still experiencing vision loss over the long-term (1, 2). Patients are often undertreated, driven in part by the high burden of frequent intravitreal injections and high rate of discontinuation, underscoring a need for more durable treatment options (1-4). Further, while anti-VEGF therapies target angiogenic drivers of disease, inflammation also plays a role in pathogenesis (5). Multi-target therapies may have the potential to improve disease control and optimize vision outcomes.

EYP-1901 (vorolanib intravitreal insert; DURAVYU™)* offers sustained release of the tyrosine kinase inhibitor (TKI) vorolanib via next-generation bioerodible Durasert E™ technology, delivering therapeutic levels for at least six months following a single intravitreal injection (6). Vorolanib works intracellularly to suppress angiogenesis through pan-VEGF receptor (VEGFR) and platelet-derived growth factor receptor (PDGFR) inhibition (7). In addition, vorolanib inhibits interleukin-6 (IL-6)-mediated inflammatory signaling via interaction with the kinase JAK1, providing a multi-mechanism of action (6,8).

EYP-1901 continues to be evaluated in a robust clinical trial program, comprising completed phase 1 and 2 trials, with phase 3 trials currently in progress (9-15). Key findings from the phase 2 DAVIO 2 (wet AMD) and VERONA (DME) studies, and an update on ongoing phase 3 trials were covered in three presentations at Retina World Congress (May 14–17, 2026; Fort Lauderdale, FL).

The phase 2 DAVIO 2 trial (NCT05381948) enrolled 161 patients with previously treated wet AMD, randomized to receive a single dose of EYP-1901 2 mg, EYP-1901 3 mg, or on-label aflibercept 2 mg every 8 weeks (q8W). Patients in all arms received 3 loading doses of aflibercept 2 mg and were eligible for supplemental injections from Week 12 per protocol-prespecified criteria. Vision outcomes, including a post hoc time-in-range (TIR) analysis, were presented by Dr. Priya Vakharia (Retina Vitreous Associates of Florida, Palm Harbor, FL). DAVIO 2 met its primary endpoint, with a single dose of EYP-1901 2 mg or 3 mg found to be statistically noninferior to aflibercept 2 mg q8W based on mean change in best-corrected visual acuity (BCVA) from baseline at Week 28/32. Receipt of supplemental treatment did not drive vision outcomes. Over 85% of EYP-1901-treated patients demonstrated stable (<5-letter change) or improved (≥5-letter increase) vision six months after a single dose. In the TIR analysis, functional vision was maintained ≥69 letters (minimum driving requirement in most U.S. states) for the majority of time with EYP-1901 (EYP-1901 2 mg, 25 of 32 weeks; EYP-1901 3 mg, 28 of 32 weeks), similarly to aflibercept 2 mg q8W (24 of 32 weeks). Overall, EYP-1901-treated patients demonstrated an ≥85% reduction in treatment burden versus pre-trial (16).

Results from the phase 2 VERONA trial (NCT06099184) were presented by Dr. Ehsan Rahimy (Palo Alto Medical Foundation; Byers Eye Institute, Palo Alto, CA). VERONA enrolled 27 previously-treated patients with active DME, who received a single dose of aflibercept 2 mg followed by a single dose of EYP-1901 1.3 mg, 2.7 mg, or sham, with patients followed for 24 weeks. The trial met its primary endpoint, with both EYP-1901 dose levels achieving extended time to first supplemental treatment versus aflibercept 2 mg. Over 70% of patients treated with EYP-1901 2.7 mg were supplement-free up to Week 24, compared to 50% in the aflibercept 2 mg arm. A single dose of EYP-1901 demonstrated early and sustained vision and anatomic improvements, with final mean BCVA change from baseline +6.9, +7.1, and +7.3 letters, and mean CST change from baseline −71.1, −75.9, and −43.7 µm in the EYP-1901 1.3 mg, EYP-1901 2.7 mg, and aflibercept 2 mg arms, respectively. Improvements were observed as early as Week 4 (the first post-treatment visit) and maintained over the course of the study. Dose-dependent reductions in macular volume and macular leakage area were also observed, with mean change from baseline in macular volume −0.37, −0.60, and −0.16 mm3, and macular leakage area −2.02, −3.14, and −0.66 mm2 in the EYP-1901 1.3 mg, EYP-1901 2.7 mg, and aflibercept 2 mg arms, respectively (17).

Across four completed phase 1 and 2 trials to date, in over 190 patients, EYP-1901 has been found to be well-tolerated, with no EYP-1901 drug-related safety concerns and no EYP-1901-related discontinuations (18).

Building on the positive phase 2 program, phase 3 trials of EYP-1901 in both wet AMD and DME are currently underway, summarized in a presentation by Dr. Ashkan M. Abbey (Texas Retina Associates, Dallas, TX). In wet AMD, LUGANO (NCT06668064) and LUCIA (NCT06683742) have enrolled more than 400 patients each, both treatment-naïve and previously treated. These noninferiority trials aim to demonstrate that EYP-1901 2.7 mg, dosed every six months, achieves similar visual outcomes to on-label aflibercept 2 mg q8W while reducing treatment burden. The primary endpoint is difference in mean change in BCVA from Day 1 to Week 52/56 average versus aflibercept control, with patients followed for 96 weeks. Topline data for LUGANO are anticipated in mid-2026, with LUCIA to follow shortly after (18). Based on interim masked safety data, the observed safety profile in LUGANO/LUCIA is consistent with previous EYP-1901 clinical trials (18,19).

In DME, phase 3 trials COMO (NCT07449936) and CAPRI (NCT07449923) are enrolling approximately 240 treatment-naïve and previously-treated patients per trial, with enrollment expected to complete in Q3 2026 (18,20). Again, these trials will evaluate non-inferiority of EYP-1901 2.7 mg dosed every six months versus on-label aflibercept control, with the primary endpoint of difference in mean change in BCVA from Day 1 to Week 52/56 averaged. Patients will be followed for 88 weeks, with topline data anticipated 2H 2027 (18).

 A robust clinical trial program to date supports the potential of EYP-1901 to provide durable treatment of retinal exudative diseases, with the goal of improving long-term vision outcomes and reducing patient treatment burden. Phase 3 results in both wet AMD and DME are eagerly anticipated.

*DURAVYU™ has been conditionally accepted by the US FDA as the proprietary name for
EYP-1901 (vorolanib intravitreal insert). EYP-1901 is an investigational medicinal product and is not authorized for sale in any country at the time of this publication. FDA approval in the US and Marketing Authorization in any other country and the timeline for potential approval or authorization is uncertain.The dose investigated in phase 3 trials is 2.686 mg (two inserts of 1.343 mg each) administered in a single injection.