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EYP-1901

Phase 3

Diabetic Macular Edema | Small molecule | Other |EyePoint, Inc.|Last Updated: Jun 3, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment507
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07449936COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DMEPHASE3 RECRUITING 240Feb 16, 2026Oct 1, 2028Jun 3, 202665 United States, Germany +3
NCT07449923CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DMEPHASE3 RECRUITING 240Feb 9, 2026Oct 1, 2028Jun 3, 202662 United States, Brazil +3
NCT06099184Study of EYP-1901 in Patients With Diabetic Macular Edema (DME)PHASE2 COMPLETED 27Jan 15, 2024Oct 24, 2024Mar 4, 20256 United States
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Study Endpoints
Primary Endpoints
Average change in best corrected visual acuity (BCVA)
Weeks 52 and 56

BCVA Early Treatment Diabetic Retinopathy Study (ETDRS) letter score change from Baseline to the average of Weeks 52 and 56

Time to first supplemental aflibercept injection following EYP-1901 dose at Baseline vs Aflibercept
Week 24

Timing of supplemental injection

Secondary Endpoints
Rate of injection burden
Week 56
Change in best corrected visual acuity (BCVA)
Week 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
EYP-1901 2686 µgEXPERIMENTALEYP-1901
AfliberceptACTIVE_COMPARATOR -
EYP-1901 1343 µgEXPERIMENTALEYP-1901 1343 µg, single dose
Interventions
NameTypeDescription
EYP-1901DRUGIntravitreal Injection
Aflibercept (2.0 mg)DRUGIntravitreal Injection
Aflibercept 2Mg/0.05Ml Inj,OphDRUGIntravitreal Injection
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites65

Inclusion Criteria: * Previously treated or treatment naïve patients with a documented diagnosis of macular edema associated with diabetic retinopathy (DR) in the study eye, with onset of disease that began at any time prior to the Screening Visit. * Best-corrected visual acuity (BCVA) Early Treatm...

Countries:United StatesGermanyIsraelPolandSlovakiaBrazilCzechiaHungary
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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT07449923lastUpdatePostDate: changed
LOWJun 4, 2026NCT07449936lastUpdatePostDate: changed
LOWJun 4, 2026NCT07449923lastUpdatePostDate: changed
LOWJun 4, 2026NCT07449936lastUpdatePostDate: changed
LOWJun 4, 2026NCT07449923lastUpdatePostDate: changed
LOWJun 4, 2026NCT07449936lastUpdatePostDate: changed
LOWJun 4, 2026NCT07449923lastUpdatePostDate: changed
LOWJun 4, 2026NCT07449936lastUpdatePostDate: changed
LOWJun 4, 2026NCT07449923lastUpdatePostDate: changed
LOWJun 4, 2026NCT07449936lastUpdatePostDate: changed
LOWMay 26, 2026NCT07449923primaryCompletionDate: changed
LOWMay 26, 2026NCT07449936primaryCompletionDate: changed
LOWMay 24, 2026NCT07449923studyFirstPostDate: changed
LOWMay 24, 2026NCT07449936studyFirstPostDate: changed