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Clinical Studies

Phase 2 – Wet AMD

DAVIO 2 evaluated a single dose of EYP-1901 vs on-label aflibercept in patients previously treated for wet AMD

DAVIO 2 Study Design:

The graphic summarizes clinical evaluation of DURAVYU across four retinal disease trials. It shows patient counts and study names including DAVIO, PAVIA, DAVIO 2, and VERONA, spanning Phase 1 and Phase 2 studies in neovascular age-related macular degeneration and diabetic macular edema. In total, more than 190 patients received DURAVYU across these studies.

Scheduled aflibercept

Scheduled visit

Sham injection for masking

Protocol prespecified Retreatment criteria*:

BCVA reduction ≥5 letters and CST increase ≥75 µm OR
vision-threatening hemorrhage OR
BCVA reduction ≥10 letters OR
CST increase ≥100 µm

Investigator discretion

Primary Endpoint

Mean change in BCVA at Months 7 and 8, averaged (6 months after EYP-1901 dose).

Patient Demographics

Previously treated patients (N=161) received ~10 anti-VEGF injections/year prior to study entry (normalized mean†; range 2–13 injections) and had a baseline of ~20/32 Snellen equivalent (mean 73–75 ETDRS letters; range 41–85 letters).

*Due to nAMD; from best on-study measurement.

†Normalized to a 12-month treatment period: number of actual injections received divided by actual months of prior treatment and multiplied by 12 months.

DAVIO 2 Results

Primary Endpoint Met:

BCVA statistically noninferior with a single EYP-1901 dose vs aflibercept 2 mg q8w with anatomical control from baseline through month 8.

BCVA statistically noninferior with a single EYP-1901 dose vs aflibercept q8w

Mean Change in BCVA From Baseline
Line graph showing mean change in best-corrected visual acuity from baseline over eight months, with EYP-1901 doses demonstrating visual acuity outcomes comparable to aflibercept and meeting the predefined noninferiority primary endpoint. Line graph showing mean change in best-corrected visual acuity from baseline over eight months, with EYP-1901 doses demonstrating visual acuity outcomes comparable to aflibercept and meeting the predefined noninferiority primary endpoint.

Anatomic control from baseline through month 8 with no sawtooth pattern following single dose of EYP-1901

Mean Change in CST From Baseline

A single dose of EYP-1901 maintained or improved vision in >80% of patients

BCVA at Month 7/8
Bar chart showing the proportion of patients with changes in best-corrected visual acuity at months 7 and 8, with more than 80 percent of patients across treatment groups experiencing stable or improved vision. Bar chart showing the proportion of patients with changes in best-corrected visual acuity at months 7 and 8, with more than 80 percent of patients across treatment groups experiencing stable or improved vision.

Vision outcomes measured by BCVA letters lost or gained.

85% overall reduction in treatment burden with a single dose of EYP-1901 vs pre-trial

63% of eyes receiving EYP-1901 were supplemental injection–free up to Month 8‡

Visualization showing treatment burden before and after a single dose of EYP-1901, with an overall reduction in injections compared with the pre-trial period and most patients remaining supplemental injection-free through month 8. Visualization showing treatment burden before and after a single dose of EYP-1901, with an overall reduction in injections compared with the pre-trial period and most patients remaining supplemental injection-free through month 8.

Percent change in treatment burden Month 2 to Month 8 from pre-trial injection burden over same duration.

‡Actual injections received; ie, does not include visits where eyes met criteria but no injection given per investigator discretion.

A Favorable Safety Profile

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

DAVIO 2 Key Safety Findings

  • No EYP-1901–related ocular or systemic serious adverse events (SAEs)
  • No insert migration into the anterior chamber
  • No cases of retinal occlusive vasculitis
  • No visual impairment due to the insert
  • No discontinuations related to EYP-1901 treatment

AMD, age-related macular degeneration; BCVA, best corrected visual acuity; CST, central subfield thickness; ETDRS, Early Treatment Diabetic Retinopathy Study; nAMD, neovascular age-related macular degeneration; q8w, every 8 weeks; SAE, serious adverse event; VEGF, vascular endothelial growth factor.

EYP-1901 is an investigational product and the safety and efficacy of EYP-1901 has not been established. FDA has not approved EYP-1901 in the United States. The materials discussed on this site do not predict future FDA approval. Conclusive evidence of efficacy and safety of EYP-1901 will require further investigation in well-controlled Phase 3 clinical trials.

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