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Aflibercept

Phase 1

Diabetic Macular Edema | Monoclonal antibody | Other |Opthea Limited|Last Updated: Apr 22, 2025

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-BlindSHAM_CONTROLLED
Total Trials1
Total Enrollment153
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03397264A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular EdemaPHASE1 COMPLETED 153 — — Jan 16, 2018Jun 11, 2020Apr 22, 202553 United States, Australia +2
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Study Endpoints
Primary Endpoints
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Baseline to Week 12

Safety and Tolerability will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events and CTC v4.0 (if available, otherwise protocol defined grading were used)

Phase 2a: Response Rate Defined as Proportion of Participants Receiving OPT-302 With Aflibercept Achieving at Least a 5-letter Gain in BCVA at Week 12
Baseline to Week 12

Change from baseline in Best Corrected Visual Acuity (BCVA) will be measured at Week 12 according to Early Treatment Diabetic Retinopathy Score (ETDRS) criteria

Secondary Endpoints
Mean Change in BCVA
Baseline to Week 12
Mean Change in CST
Baseline to Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Ph 1b: 2.0 mg aflibercept with 0.3 mg OPT-302EXPERIMENTAL2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 0.3 mg OPT-302 intravitreal injection (0.05 mL)
Ph 1b: 2.0 mg aflibercept with 1.0 mg OPT-302EXPERIMENTAL2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 1.0 mg OPT-302 intravitreal injection (0.05 mL)
Ph 1b: 2.0 mg aflibercept with 2.0 mg OPT-302EXPERIMENTAL2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)
Ph 2a: 2.0 mg aflibercept with 2.0 mg OPT-302EXPERIMENTAL2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)
Ph 2a: 2.0 mg aflibercept with shamSHAM_COMPARATOR2.0 mg aflibercept intravitreal injection (0.05 mL) followed by sham intravitreal injection
Interventions
NameTypeDescription
AfliberceptBIOLOGICALIntravitreal injection
OPT-302BIOLOGICALIntravitreal Injection
Sham intravitreal injectionOTHERSham (mock) intravitreal injection
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites53

Inclusion Criteria: * History of diabetic macular edema (DME) ≤ 2 year * Persistent DME despite prior intravitreal anti-VEGF-A therapy with a sub-optimal response * Three or more prior anti-VEGF-A therapy intravitreal injections * EDTRS BCVA score ≤ 73 and ≥ 24 letters Exclusion Criteria: * Ocula...

Countries:United StatesAustraliaIsraelLatvia
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Competitive Landscape -Diabetic Macular Edema 15 trials
CompanyTickerTrialsLead PhaseDrugs
EyePoint, Inc.EYPT2PHASE3EYP-1901, Aflibercept
Regeneron Pharmaceuticals, Inc.REGN1PHASE3Aflibercept
Oculis Holding AGOCS2PHASE3Dexamethasone, Vehicle
AbbVie, Inc.ABBV3PHASE2ABBV-RGX-314 Dose 1, Steroid, Aflibercept
Outlook Therapeutics, Inc.OTLK1PHASE3bevacizumab
4D Molecular Therapeutics, Inc.FDMT1PHASE24D-150 IVT, Aflibercept IVT
AlvotechALVO1PHASE3AVT29, Eylea HD
Kiora Pharmaceuticals, Inc.KPRX1PHASE2KIO-104
REGENXBIO, Inc.RGNX1PHASE2RGX-314 Dose 1, RGX-314 Dose 2, Aflibercept
Ocugen IncOCGN1PHASE1OCU200
Adverum Biotechnologies, Inc.ADVM1 — ADVM-022
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