Registered study summary

“This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.” (opens the source at this quote in a new tab)

Program objective: similar vision with dosing every 6 months and lower treatment burden

“Objective: Demonstrate that EYP-1901, when administered every 6 months, achieves similar visual outcomes to on-label aflibercept while reducing treatment burden in patients with nAMD” (opens the source at this quote in a new tab)

Role in the planned New Drug Application after LUGANO

“Submit comprehensive Phase 3 data package (LUGANO & LUCIA) to FDA, including pooled data H1 2027” (opens the source at this quote in a new tab)

“We look forward to a potential New Drug Application (NDA) filing with FDA in the first half of 2027, pending LUCIA results in the fourth quarter of 2026.” (opens the source at this quote in a new tab)

Summary: sites and timeline

The ClinicalTrials.gov record (last updated 2026-09-03) lists 113 locations: 78 in the United States, 7 in Israel, 7 in Poland, 6 in India, 5 in Brazil, 4 in Hungary, 3 in Czechia, and 1 each in Germany, Slovakia, and the United Kingdom. The 2025 enrollment completion announcement also names participation in Australia, which the registry does not list. The first participant was dosed in December 2024 (registry study start 2024-11-27), enrollment was completed on July 29, 2025, primary completion is estimated for 2026-10, topline data are expected in the fourth quarter of 2026, and study completion is estimated for 2027-10.

Registry dates

Milestone	Registry record
Study start (actual)	“2024-11-27”
Primary completion (estimated)	“2026-10”
Study completion (estimated)	“2027-10”

Countries

“LUCIA also marked our expansion beyond the U.S. with patient participation in South America, Europe, Israel, Australia and India, demonstrating global momentum and interest in DURAVYU.” (opens the source at this quote in a new tab)

“We expect continued strong momentum, with sites outside the US now actively enrolling along with select LUGANO sites preparing to cross over to LUCIA.” (opens the source at this quote in a new tab)

First participant dosed

“today announced that the first patient has been dosed in the LUCIA trial, the Company’s second global Phase 3 clinical trial of DURAVYU, formerly EYP-1901, for the treatment of wet age-related macular degeneration (wet AMD).” (opens the source at this quote in a new tab)

Enrollment completion

“We successfully completed enrollment in our two pivotal Phase 3 clinical trials: the LUGANO trial on May 27, 2025, and the LUCIA trial on July 29, 2025.” (opens the source at this quote in a new tab)

Expected topline results

“The Company remains on track to report topline data from the second wet AMD pivotal Phase 3 LUCIA trial in the fourth quarter of 2026.” (opens the source at this quote in a new tab)

Phase 3, randomized, double-masked, parallel-group, aflibercept-controlled design

“A 2-year Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Wet AMD” (opens the source at this quote in a new tab)

Identical design to LUGANO

“LUGANO and LUCIA are identical, randomized, double-masked, aflibercept controlled, non-inferiority Phase 3 trials assessing the efficacy and safety of DURAVYU in patients with active wet AMD including both treatment naïve and treatment experienced patients.” (opens the source at this quote in a new tab)
“At Day 1, patients are randomized 1:1 to receive either DURAVYU 2.7mg every six months or on-label aflibercept as control.” (opens the source at this quote in a new tab)

“The LUCIA trial enrolled a very similar patient population, although the trial was slightly larger, at 475 patients. But the protocol is essentially identical.” (opens the source at this quote in a new tab)

Aflibercept loading, sham masking, and 24-month safety follow-up

“All participants will receive 3 loading doses of aflibercept” (opens the source at this quote in a new tab)
“Sham injections used for masking” (opens the source at this quote in a new tab)
“On-label aflibercept control group” (opens the source at this quote in a new tab)

“In June 2024, we announced alignment on pathway to approval with U.S. Food and Drug Administration (FDA) based on positive End of Phase 2 meeting in April 2024 for two non-inferiority trials, 6-month redosing of DURAVYU™ and sham for masking with a one-year endpoint.” (opens the source at this quote in a new tab)
“Safety evaluation only will be continued through year two of the trials.” (opens the source at this quote in a new tab)

Independent Data Safety Monitoring Committee

“DSMC meetings are scheduled to occur every six months per the trial protocol, and this is the last anticipated DSMC meeting ahead of topline data.” (opens the source at this quote in a new tab)

Key inclusion criteria

Criterion	Quoted registry text
Minimum age	“50 Years”
Diagnosis and prior treatment status	“Previously treated or treatment naïve patients with a documented diagnosis of wAMD in the study eye, with onset of disease that began at any time prior to the Screening Visit.”
Visual acuity in the study eye	“Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score between 78 to 35 letters (approximately 20/32 to 20/200 Snellen equivalent) in the study eye at the Screening Visit and on Baseline (Day 1).”
Previously treated participants	“For previously-treated subjects, must have been treated with at least 2 anti-VEGF IVT injections (i.e., aflibercept 2 mg, aflibercept 8 mg, bevacizumab, ranibizumab, or faricimab) in the previous 6 months for wAMD per standard of care in the study eye prior to the Screening Visit.”

Key exclusion criteria

“Subfoveal fibrosis, atrophy, or scarring in the center subfield” (opens the source at this quote in a new tab)
“Fellow eye BCVA <20 letters (20/400 Snellen equivalent)” (opens the source at this quote in a new tab)

Planned mix of treatment-naive and previously treated participants

“Trials include approximately 75% treatment-naïve and 25% previously treated patients.” (opens the source at this quote in a new tab)

Registered arms

Arm	Arm label	Intervention
Experimental	“EYP-1901 2686 µg”	“Intravitreal Injection”
Active comparator	“Aflibercept”	“Aflibercept (2.0 mg)”

Dosing schedule: vorolanib insert every 6 months from month 2

“Patients in the DURAVYU treatment arm will receive an intravitreal injection of DURAVYU every six months, starting at month two of the trial.” (opens the source at this quote in a new tab)

“Patients in the DURAVYU 2.7mg treatment arm will be re-dosed every six months for a total of four doses over the two-year trial.” (opens the source at this quote in a new tab)

Supplemental aflibercept criteria

“Supplemental aflibercept per prespecified criteria (all arms)” (opens the source at this quote in a new tab)
“BCVA reduction of ≥5 letters from best on-study measurement due to nAMD AND CST increase of ≥75 microns on SD-OCT from lowest on-study measurement” (opens the source at this quote in a new tab)

“> 5 letter drop with 75 microns new fluid from AMD compared to best on study, or new, sight threatening hemorrhage due to wet AMD” (opens the source at this quote in a new tab)

Dosing visits reached during the trial

“As of May 2, 2026, all active patients in the treatment arm have reached the Week 32 visit, during which patients received their second DURAVYU dose. Over 35% of those patients have also received their third planned dose at Week 56.” (opens the source at this quote in a new tab)

Summary: rationale for the endpoint and margin

LUCIA uses the same primary endpoint and -4.5-letter margin as LUGANO. The sponsor cites non-inferiority margin precedent from recent FDA approvals in neovascular AMD, and published phase 3 trials in neovascular AMD used margins of 4.5 letters (Archway, port delivery system with ranibizumab) or 4 letters (TENAYA and LUCERNE, faricimab; PULSAR, aflibercept 8 mg).

Registered outcomes

Outcome type	Measure	Time frame
Primary	“Average change in best corrected visual acuity (BCVA)”	“Weeks 52 and 56”
Secondary	“Rate of injection burden”	“Week 56”
Secondary	“Average change in best corrected visual acuity (BCVA)”	“Week 96”

Primary endpoint and non-inferiority margin of 4.5 letters

“LUGANO & LUCIA Follow Established Non-Inferiority Regulatory Path in Wet AMD Endpoints Primary Endpoint: Non-inferior (NI) mean change in BCVA from Day 1 to Week 52 and Week 56 (blended) vs aflibercept control (NI margin of -4.5 letters)” (opens the source at this quote in a new tab)

Secondary endpoints

“Primary endpoint Difference in mean change in BCVA from Day 1 to W52 and 56 (averaged) vs aflibercept control” (opens the source at this quote in a new tab)
“Secondary endpoints • Safety • Reduction in treatment burden • Percent of eyes supplement-free • Anatomical stability” (opens the source at this quote in a new tab)

PULSAR: sample size assumptions and noninferiority test results at the four-letter margin

“A SD of 13·6 letters was assumed for each group. Assuming a dropout rate of 10% by week 48, approximately 320 patients were planned for each group.” (opens the source at this quote in a new tab)
“The aflibercept 8q12 and 8q16 groups met the primary efficacy endpoint and showed non-inferior BCVA gains compared with the aflibercept 2q8 group, based on a non-inferiority margin of 4 letters” (opens the source at this quote in a new tab)
“The estimated difference in least square mean changes from baseline to week 48 in BCVA for aflibercept 8q12 versus 2q8 was –0·97 (95% CI –2·87 to 0·92; noninferiority test at four-letter margin: p=0∙0009) and for aflibercept 8q16 versus 2q8 was –1·14 (–2·97 to 0·69; p=0∙0011).” (opens the source at this quote in a new tab)

Planned enrollment

Source field	Value
Registry enrollment (estimated)	“400”

Enrolled and randomized participants

“The LUGANO trial enrolled 432 patients and the LUCIA trial enrolled 475 patients who were randomly assigned, 1:1, to a DURAVYU 2.7mg arm or an on-label aflibercept control arm.” (opens the source at this quote in a new tab)

“The LUCIA trial has enrolled and randomized over 400 patients in seven months making DURAVYU one of the fastest enrolling Phase 3 pivotal programs in wet AMD.” (opens the source at this quote in a new tab)

Participants analyzed

No evidence found.

Analysis plan informed by LUGANO results

“Includes learnings from LUGANO for the LUCIA analysis plan, ahead of topline results” (opens the source at this quote in a new tab)

Analysis populations, model, and multiplicity control

No evidence found.

Topline efficacy results

No evidence found.

Sponsor expectation of regression to the mean in 15-letter losses

“If LUCIA shows a regression to the mean in 15-letter losers, then we would be confident that our drug would be shown to be noninferior.” (opens the source at this quote in a new tab)

“Modeling demonstrates impact of control arm overperformance and supports potential regression-to-the-mean for LUCIA” (opens the source at this quote in a new tab)

Interim masked safety across LUGANO and LUCIA

“Interim masked safety data from the Phase 3 trials show a continued favorable safety profile for DURAVYU, consistent with the safety observed in over 190 patients across four completed clinical trials.” (opens the source at this quote in a new tab)

“The Company also announced that based on interim masked safety data, the safety profile observed in LUGANO and LUCIA is consistent with previous DURAVYU clinical trials.” (opens the source at this quote in a new tab)

Unmasked LUCIA safety results

No evidence found.

Summary

No LUCIA efficacy or safety results have been reported as of September 2026; topline data are expected in the fourth quarter of 2026, and the only safety information is interim masked data pooled with LUGANO.
The sponsor states that learnings from LUGANO were included in the LUCIA analysis plan before LUCIA topline results; the content of these changes has not been disclosed, and changes made after results of an identical trial are known may affect how the LUCIA primary analysis is interpreted.
The design is identical to LUGANO, so the same design limitations apply: three aflibercept loading doses before the first insert, supplemental aflibercept in both arms, a fixed aflibercept 2 mg every 8 weeks comparator, a -4.5-letter margin, efficacy assessed to week 56 with safety-only follow-up in year 2, and exclusion of only center-subfield atrophy.
Enrollment (475 participants) exceeded the registry estimate of 400, and the registry lists 113 sites in 10 countries, 78 (69.0%) of them in the United States; the registry does not list Australia, which the sponsor named as a participating country.
If LUCIA meets its primary endpoint, the planned New Drug Application would rest on one trial meeting and one identical trial not meeting the prespecified primary endpoint, together with pooled data.