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ICM ADX-2191

Phase 3

Primary Vitreoretinal Lymphoma | Small molecule | Oncology |Aldeyra Therapeutics, Inc.|Last Updated: Feb 11, 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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07402876A Clinical Trial Evaluating Patients With Primary Vitreoretinal LymphomaPHASE3 RECRUITING 20Feb 1, 2026Dec 1, 2026Feb 11, 20261 United States
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Study Endpoints
Primary Endpoints
Proportion of clearance of lymphomatous vitreous cells compared across ICM and monthly ADX-2191 treatment groups after eight weeks of treatment
Eight weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Induction/Consolidation/Maintenance (ICM) ADX-2191 injectionEXPERIMENTAL -
Monthly ADX-2191 injectionACTIVE_COMPARATOR -
Interventions
NameTypeDescription
ICM ADX-2191 injectionDRUGFollowing the development of lymphomatous vitreous cells in at least one eye, subjects will follow ICM dosing with ADX-2191 intravitreal injections twice weekly for four weeks, followed by weekly for eight weeks, for a total of sixteen injections.
Monthly ADX-2191 injectionDRUGFollowing the development of lymphomatous vitreous cells in at least one eye, subjects will dose monthly with ADX-2191 intravitreal injections for a total of three injections. Sham injections will be performed for those visits during which ADX-2191 is not injected, for a total of thirteen sham injections.
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Eligibility Criteria
Age Range21 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. 21 years old or older; of any gender 2. Biopsy proven primary vitreoretinal lymphoma 3. Presence of lymphomatous vitreous cells at the Screening Visit and/or any eye that has been vitrectomized to confirm the diagnosis of primary vitreoretinal lymphoma 4. Willingness to parti...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07402876primaryCompletionDate: changed
LOWMay 24, 2026NCT07402876studyFirstPostDate: changed