Phase 2
N=161
Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD)
Wet Age-related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT05381948 ↗Enrolled (actual)
161
Serious AEs
6.0%
Results posted
Oct 2025
Primary outcome: Primary: Average Change in Best Corrected Visual Acuity (BCVA) From Baseline Averaged Over Weeks 28 and 32 — 1.17; 1.05; 0.87 score on a scale — p=0.919
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- EYP-1901 (Drug); Aflibercept 2mg/0.05mL Inj,Oph (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- EyePoint Pharmaceuticals, Inc.
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Change in Best Corrected Visual Acuity (BCVA) From Baseline Averaged Over Weeks 28 and 32 |
1.17; 1.05; 0.87 | 0.919 |
| SECONDARY Change From Baseline in Best Corrected Visual Acuity up to Week 56 |
73.4; 73.9; 74.9; 1.6; 1.0; 0.8 | — |
| SECONDARY Percentage of Subjects With >=5, >=10, and >=15 BCVA Letter Change From Baseline up to Week 56 |
34.0; 25.0; 21.2; 13.2; 20.8; 11.5 | — |
| SECONDARY Percentage of Subjects Not Receiving Supplemental Injection of Aflibercept up to Week 56 |
94.3; 62.5; 63.5; 82.7; 42.6; 46.2 | — |
| SECONDARY Median Time to First Supplemental Aflibercept Injection in the Study Eye Following the EYP-1901 Dose at Week 8 |
37.00; 40.79 | — |
| SECONDARY Number of Aflibercept Intravitreal Injections up to Week 56 (Including Loading Dose) |
3.23; 2.06; 2.13; 6.33; 3.45; 3.36 | — |
| SECONDARY Mean Change From Baseline in Central Subfield Thickness (CST) by Spectral-Domain - Optical Coherence Tomography (SD-OCT) up to Week 56 |
265.7; 264.5; 262.9; 5.4; 17.8; 10.6 | — |
| SECONDARY Change From Baseline in Height of Subretinal Fluid by Spectral-Domain - Optical Coherence Tomography up to Week 56 |
46.87; 49.84; 50.71; 33.05; 18.75; 10.68 | — |
| SECONDARY Percentage of Subjects With No Detectable Intraretinal Fluid/Cysts in the Central Subfield up to Week 56 |
62.3; 52.1; 51.9; 59.6; 59.6; 51.9 | — |
| SECONDARY Change From Baseline in Total Lesion Area by Fluorescein Angiography (FA) up to Week 56 |
5.06884; 5.48285; 4.82169; 1.24141; 1.07111; 1.13971 | — |
| SECONDARY Change From Baseline in Total Choroidal Neovascularization Area by Fluorescein Angiography up to Week 56 |
5.06; 5.44; 4.77; 1.15; 1.10; 1.19 | — |
| SECONDARY Systemic Exposure to EYP-1901 Measured Through Plasma Levels up to Week 56 |
0.000; 0.000; 0.00; 0.00; 23.206; 27.121 | — |
| SECONDARY Ocular Exposure to EYP-1901 Measured Through Aqueous Humor (AH) Levels up to Week 32 |
0.000; 0.000; 0.00; 0.00; 17.426; 25.066 | — |
| SECONDARY Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Treatment-Emergent Adverse Events up to Week 56 |
30; 21; 40; 30; 11; 28 | — |
Summary
This is a phase 2 randomized, double -masked study comparing the efficacy of EYP-1901 at 2 dose levels: 2060 microgram (mcg) and 3090 mcg against aflibercept.
Eligibility Criteria
Inclusion Criteria
- Documented diagnosis of wAMD in the study eye, with disease onset any time prior to the Screening Visit.
- Documented anatomical response (that is, reduction in fluid on [spectral-domain - optical coherence tomography (SD-OCT)] to previous intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections in the study eye prior to the Screening Visit.
- Previously treated with at least 2 anti-VEGF intravitreal injections (that is, bevacizumab, ranibizumab, aflibercept or faricimab) for wAMD per standard of care in the study eye within 6 months prior to the Screening Visit.
- Received previous anti-VEGF therapy 2 to 5 weeks (14 to 35 days) in the study eye prior to Screening Visit, but no more than 42 days prior to randomization to study treatment on Day 1.
- Best corrected visual acuity (BCVA) early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 35 letters (20/200 Snellen equivalent) to 85 letters (20/20 Snellen equivalent) in the study eye at the Screening Visit and on Day 1.
- Able to understand, and willingness to sign, the informed consent and to provide access to personal health information via Health Insurance Portability and Accountability Act (HIPAA) authorization.
- Willingness and ability to comply with all scheduled visits, restrictions, and assessments.
- For women of childbearing potential, or men with female partners of childbearing potential, agreement to the use of an appropriate form of contraception at the Screening Visit and for the duration of the study.
Exclusion Criteria
- History of pars plana vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye.
- Prior treatment with Visudyne® (verteporfin), external beam radiation therapy, or transpupillary thermotherapy in the study eye.
- Previous treatment with intravitreal corticosteroid injection or device implantation in the study eye.
- Previous focal laser photocoagulation used for AMD treatment in the study eye.
- Total choroidal neovascularization (CNV) lesion size >12 disc areas [30.5 millimeter square (mm^2)] as assessed by fluorescein angiography (FA) in the study eye at the Screening Visit.
- Central subfield thickness (CST) >350 micrometer (mcm) in the study eye at the Screening Visit or Day 1.
- Intraretinal cystic fluid >25 mcm in diameter involving the central subfield and/or disruption of normal morphology (loss of foveal depression, disruption of external limiting membrane) secondary to cystic intraretinal fluid within the central subfield, in the study eye at the Screening Visit. Diffuse (non-cystic) intraretinal fluid would not be excluded.
- Subretinal hemorrhage in the subfoveal/juxtafoveal location and hemorrhage greater than 1 disc are (1.8 mm^2) if located less than 200 mcm from the foveal center in the study eye at either the Screening Visit or Day 1.
- Subfoveal fibrosis, atrophy, or scarring in the center subfield in the study eye at the Screening Visit.
- Fibrosis >50% of the total lesion, in the study eye at the Screening Visit.
- Retinal pigment epithelium detachment (RPED) thickness >400 mcm at any point within 3 mm of the foveal center in the study eye at either the Screening Visit or Day 1.
- Retinal pigment epithelial tear in the study eye at the Screening Visit or Day 1.
- Any concurrent intraocular condition in the study eye (e.g., cataract or glaucoma) that, in the opinion of the investigator, would have either required surgical intervention during the study to prevent or treat visual loss that might result from that condition or affected interpretation of the study results.
- Historical or active intraocular inflammation (grade trace or above) in the study eye, other than expected findings from routine cataract surgery.
- History of vitreous hemorrhage in the study eye within 12 weeks prior to the Screening Visit.
- History of rhegmatogenous retinal detachment or treatment for retinal detachment or macular hole (stage 3 or 4) in the stud
Data sourced from ClinicalTrials.gov (NCT05381948). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.