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Clinical Studies

Phase 3 Clinical Studies

Wet AMD Phase 3 Program Overview

EYP-1901 is currently being studied in phase 3 trials for wet AMD and DME.

This phase 3 program follows a well-established regulatory approval pathway with patient-centric, non-inferiority trials compared with on-label aflibercept—designed to inform real-world treatment practices.

Phase 3 Trials Are Designed to Enable Global Regulatory Approval of EYP-1901
LUGANO and LUCIA Trials: global, randomized, double-masked, aflibercept-controlled

Objective:

Demonstrate EYP-1901, when administered every 6 months, achieves similar visual outcomes to on-label aflibercept while reducing treatment burden

Trial Design:

  • ~400 patients per trial
  • Two arms
    • EYP-1901 (2.7 mg)
    • Aflibercept on-label control (2 mg q8w)
  • EYP-1901 dosing every 6 months
  • One-year efficacy and safety endpoint for NDA submission

Primary Endpoint:

The difference in mean change in BCVA from Day 1 to Week 52 and 56 (blended) versus aflibercept control

Secondary Endpoints:

Safety, statistically superior reduction in treatment burden, percent of eyes supplement-free, anatomical stability

Wet AMD Phase 3 Pivotal Trial Design

LUGANO and LUCIA
Phase 3 pivotal trial design for wet age-related macular degeneration showing the LUGANO and LUCIA studies, comparing DURAVYU and aflibercept. Design shows scheduled dosing, masking, and supplemental anti-VEGF allowed per protocol through long-term follow-up.

EYP-1901 dosing + aflibercept

EYP-1901 dosing

Sham injection for masking

Aflibercept + sham injection for masking

Scheduled aflibercept

Scheduled visit

Continued sham or aflibercept q8W

EYP-1901 dosing consists of 2 inserts delivered in a single injection.

DME Phase 3 Program Overview

EYP-1901 is currently being studied in 2 ongoing phase 3 trials in DME: COMO and CAPRI.

This phase 3 program follows a well-established regulatory approval pathway with patient-centric, non-inferiority trials compared with on-label aflibercept—designed to inform real-world treatment practices.

Phase 3 Trials Are Designed to Enable Global Regulatory Approval of EYP-1901
COMO and CAPRI Trials: global, randomized, double-masked, aflibercept-controlled

Objective:

Demonstrate EPY-1901 administered every six months achieves similar visual outcomes to on-label aflibercept while reducing treatment burden

Trial Design:

  • Two pivotal, non-inferiority trials
  • ~240 patients per trial
  • Two arms
    • EYP-1901 (2.7 mg)
    • Aflibercept on-label (2 mg)
  • Treatment-experienced and treatment-naïve patients

Primary Endpoint:

Difference in mean change in BCVA from 
Day 1 to Week 52 and 56 (blended) versus aflibercept control

Secondary Endpoints:

Safety, reduction in treatment burden, percent of eyes supplement-free, anatomical stability

DME Phase 3 Pivotal Trial Design

COMO and CAPRI
Phase 3 pivotal trial design for diabetic macular edema showing the COMO and CAPRI studies, comparing DURAVYU and aflibercept. Design shows scheduled dosing, masking, and supplemental anti-VEGF permitted per protocol through long-term follow-up.

EYP-1901 dosing + aflibercept

EYP-1901 dosing

Sham injection for masking

Aflibercept + sham injection for masking

Scheduled aflibercept

Scheduled visit

Continued sham or aflibercept q8W

EYP-1901 dosing consists of 2 inserts delivered in a single injection.
*Criteria for supplemental injection assessed starting after Week 16 and at every subsequent visit.

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, Marketing Authorization in any other country, and the timeline for potential approval or authorization is uncertain. DURAVYU has been conditionally accepted by the US FDA as the proprietary name for EYP-1901 (vorolanib intravitreal insert).

AMD, age-related macular degeneration; BCVA, best corrected visual acuity; DME, diabetic macular edema; FDA, US Food & Drug Administration; NDA, new drug application; q6m, every 6 months; q8w, every 8 weeks; VEGF, vascular endothelial growth factor.

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