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Clinical Studies

Phase 2 – DME

VERONA evaluated EYP-1901 vs aflibercept in patients with active DME

VERONA Study Design:

VERONA study design showing a Phase 2 clinical trial of single-dose EYP-1901 at two dose levels compared with aflibercept, with scheduled visits, supplemental anti-VEGF per protocol, and a primary endpoint assessed at week 24.

Scheduled aflibercept

Scheduled visit

Sham injection

Protocol prespecified Retreatment criteria:

Starting at Week 4: BCVA reduction 5–9 letters and CST increase >75 µm on 2 consecutive visits†‡ OR
BCVA reduction ≥10 letters due to DME† OR
CST increase ≥100 µm‡ vs baseline OR
Investigator discretion

Starting at Week 12: Lack of 10% reduction in CST vs Baseline

Primary Endpoint:

Time to first supplemental anti-VEGF injection.

Patient Demographics:

Patients with active DME received ~2.7 anti-VEGF injections in the past year (mean; range 2–13 injections), diagnosed ~3 years prior (mean; range, 1–8 years), had a baseline of ~20/50 Snellen equivalent (mean 66–67 ETDRS letters; range 46–75 letters), and ~392–430 μm CST (mean; range, 320–645 µm).

*After screening, patients received a single aflibercept injection at Day 1 and were evaluated monthly for supplemental treatment (off-label aflibercept use). There was no loading phase.
†Relative to best on-study measurement.
‡CST as measured by SD-OCT.

VERONA Results

Primary Endpoint Met:

Both EYP-1901 dose levels demonstrated extended time to first supplemental treatment vs aflibercept—with the majority of EYP-1901 patients supplement-free up to Week 24

Cumulative supplement-free rates up to week 24, full analysis set§

Donut charts showing cumulative supplement-free rates through week 24, with rates of 60 percent for EYP-1901 1.3 mg, 73 percent for EYP-1901 2.7 mg, and 50 percent for aflibercept.Donut charts showing cumulative supplement-free rates through week 24, with rates of 60 percent for EYP-1901 1.3 mg, 73 percent for EYP-1901 2.7 mg, and 50 percent for aflibercept.

Both EYP-1901 dose levels demonstrated extended time to first supplemental treatment vs aflibercept

Summary of Eyes Requiring Supplemental Injections, Full Analysis Set
Line graph showing the cumulative proportion of eyes requiring supplemental injections through week 24, with increasing supplementation over time across EYP-1901 dose groups and aflibercept. Line graph showing the cumulative proportion of eyes requiring supplemental injections through week 24, with increasing supplementation over time across EYP-1901 dose groups and aflibercept.

Graph depicts supplemental-injection rates through (ie, including) the specified study week.

§Supplement-free rates up to Week 24 reflect rates prior to any treatments given during the Week 24 visit.

BCVA and CST outcomes: A single EYP-1901 dose resulted in a clinically meaningful improvement with early bioavailability

BCVA and CST Changes From Baseline, Full Analysis Set
Dual line charts showing changes in best-corrected visual acuity and central subfield thickness from baseline through week 24, illustrating early bioavailability and sustained visual and anatomical outcomes across EYP-1901 dose groups and aflibercept. Dual line charts showing changes in best-corrected visual acuity and central subfield thickness from baseline through week 24, illustrating early bioavailability and sustained visual and anatomical outcomes across EYP-1901 dose groups and aflibercept.

In a subgroup analysis of supplement-free eyes, a single dose of EYP-1901 demonstrated better BCVA and fluid outcomes vs aflibercept in eyes that remained supplement-free through Week 24

BCVA and CST Changes From Baseline, Supplement-Free Subgroup
Line graph showing change in best-corrected visual acuity from baseline through week 24 in the supplement-free subgroup, with sustained visual acuity improvements observed across EYP-1901 dose groups and aflibercept. Line graph showing change in best-corrected visual acuity from baseline through week 24 in the supplement-free subgroup, with sustained visual acuity improvements observed across EYP-1901 dose groups and aflibercept.

Supplement-free is defined as patients who did not receive a supplement at any point during the study.

A Favorable Safety Profile

EYP-1901 was well-tolerated—No SAEs related to EYP-1901 reported

VERONA Key Safety Findings

  • No EYP-1901-related ocular or systemic SAEs
  • No cases of:
    • Endophthalmitis
    • Retinal vasculitis (occlusive or non-occlusive)
    • Intraocular inflammation (IOI)
    • Insert migration into the anterior chamber
  • No visual impairment due to the insert
  • No discontinuations

BCVA, best corrected visual acuity; CST, central subfield thickness; DME, diabetic macular edema; ETDRS, Early Treatment Diabetic Retinopathy Study; SAE, serious adverse event; SD-OCT, spectral-domain optical coherence tomography; VEGF, vascular endothelial growth factor.

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