Current anti-VEGF therapies for wet age-related macular degeneration (AMD) and diabetic macular edema (DME) are frequently discontinued, due in part to the high treatment burden associated with regular injections (1-3). In addition, anti-VEGFs only treat one aspect of disease pathogenesis, with inflammation still playing a key role (4). As such, an unmet need persists for comprehensive, durable treatment options in retinal exudative diseases. EYP-1901 (vorolanib intravitreal insert; DURAVYU™)* provides sustained release of the tyrosine kinase inhibitor (TKI) vorolanib via next-generation bioerodible Durasert E™ technology, with consistent drug delivery over at least 6 months. Vorolanib offers a novel multi-mechanism of action, working intracellularly to suppress angiogenesis through the inhibition of all vascular endothelial growth factor receptors (VEGFRs) and platelet-derived growth factor receptor (PDGFR), as well as suppressing inflammation through the inhibition of interleukin-6 (IL-6) signaling (5).
Supportive evidence for EYP-1901 continues to build through a robust clinical trial program. The Phase 1 dose-escalation trial DAVIO (NCT04747197) provided proof-of-concept, enrolling 17 patients with previously-treated wet AMD (6, 7). The subsequent Phase 2 DAVIO 2 trial (NCT05381948) enrolled 161 patients who were randomized to receive a single 2 mg or 3 mg dose of EYP-1901 or aflibercept 2 mg every-8-weeks (q8W) (8). DAVIO 2 met its primary endpoint, with EYP-1901 2 mg and 3 mg both demonstrating statistical noninferiority to aflibercept 2 mg q8W on best-corrected visual acuity (BCVA) change from baseline averaged over Week 28/32 (9). EYP-1901 provided continuous stable anatomic control, and substantially reduced patient treatment burden (89% and 85% reduction vs pre-trial in the 2 mg and 3 mg arm, respectively) (10). Pivotal Phase 3 trials LUGANO (NCT06668064) and LUCIA (NCT06683742) are ongoing to demonstrate safety and efficacy of EYP-1901 with 6-month redosing in previously-treated and treatment-naïve patients with wet AMD (11, 12). These are identical randomized, double-masked noninferiority trials enrolling 432 and 475 patients who receive EYP-1901 2.7 mg every 6 months following 3 monthly aflibercept injections, or on-label aflibercept 2 mg q8W (13). The primary endpoint is mean change in BCVA from Day 1 to Week 52/56 averaged vs aflibercept q8W. Enrollment is complete, with topline data for LUGANO anticipated mid-2026 and LUCIA to follow (14). Masked interim patient baseline characteristics aligned with expectations per study design, with mean baseline BCVA of about 65 ETDRS letters (20/50 Snellen equivalent) (15). LUGANO and LUCIA have received two consecutive positive recommendations from the independent Data Safety Monitoring Committee (DSMC), with no changes to protocol required (16).
To contextualize potential Phase 3 results in wet AMD, a post hoc analysis** of DAVIO 2 data examined visual and anatomic outcomes in patients who met Phase 3 criteria. Patients in DAVIO 2 meeting Phase 3 vision inclusion criteria (baseline BCVA 35–78 letters, vs 35–85 letters in Phase 2) demonstrated stable vision and central subfield thickness (CST) across arms, similar to the full patient population (15). Both Phase 2 and Phase 3 trials include supplemental treatment with aflibercept 2 mg per protocol prespecified criteria, with streamlined criteria for Phase 3 (15). A further post hoc analysis** assessed rate of supplemental treatments in patients from DAVIO 2 with phase 3 supplemental treatment criteria applied. Fewer patients in DAVIO 2 would have received supplemental treatment per phase 3 criteria compared to phase 2 criteria (21% vs 38%, and 14% vs 37% for EYP-1901 2 mg and 3 mg arms, respectively) (15).
In DME, the Phase 2 VERONA trial (NCT06099184) enrolled 27 patients who received a single dose of aflibercept 2 mg followed by a single 1.3 mg or 2.7 mg dose of EYP-1901 or sham. The trial met its primary endpoint; both EYP-1901 dose levels achieved extended time-to-first supplemental injection versus aflibercept, with early and sustained vision and anatomic improvement in the EYP-1901 arms (17). Preparations for pivotal phase 3 trials are underway – COMO and CAPRI will compare EYP-1901 2.7 mg dosed every 6 months to on-label aflibercept 2 mg q8W in approximately 240 treatment-naïve and previously-treated patients in each study. Enrollment is expected to commence in Q1, 2026 (18).
A robust clinical trial program supports EYP-1901’s potential to fulfill unmet needs in retinal exudative diseases, with reduced treatment burden. Across four completed clinical trials to date, EYP-1901 has demonstrated a favorable safety and tolerability profile with no safety signals (5). Pivotal Phase 3 trials are underway in both wet AMD and DME, informed by the success of completed Phase 1 and 2 trials.
*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.
**Post hoc analysis, not predictive of Phase 3 results.
References
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- BL Kuo et al., “Long-term treatment patterns for diabetic macular edema: Up to 6-year follow-up in the IRIS® registry,” Ophthalmol Retina, 8, 1074 (2024). DOI: 10.1016/j.oret.2024.05.017.
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- M Singer, R Ribeiro, “DAVIO 2 trial results: Assessment of treatment burden in wet age-related macular degeneration treated with EYP-1901 (vorolanib intravitreal insert) versus aflibercept,” Presented at: Macula Society Annual Meeting; Charlotte Harbor, FL (2025). Accessed January 7, 2026.
- ClinicalTrials.gov, “A 2-year study of EYP-1901 in subjects with wet age related macular degeneration (wAMD) (LUGANO) primary efficacy will be determined at Week 56 (wAMD),” National Library of Medicine (US), (2024).
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