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GB-102

Phase 2

Diabetic Macular Edema | Small molecule | Other |LENZ Therapeutics, Inc.|Last Updated: Nov 22, 2021

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment21
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04085341A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Diabetic Macular Edema and Retinal Vein OcclusionPHASE2 COMPLETED 21Sep 11, 2019Jun 5, 2020Nov 22, 20216 United States
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Study Endpoints
Primary Endpoints
Occurrence of Adverse Events (AEs) Across All Study Visits
Baseline through Month 6

Number of subjects with an adverse event across all study visits

Secondary Endpoints
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) (ETDRS) at All Study Visits
Baseline to Month 6
Mean Change From Baseline in Central Subfield Thickness (CST) (SD-OCT) at All Study Visits
Baseline to Month 6
Time to Rescue Treatment
Baseline through Month 6
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GB-102 Dose 1 (1 mg)EXPERIMENTALParticipants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline.
GB-102 Dose 2 (2 mg)EXPERIMENTALParticipants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline.
Interventions
NameTypeDescription
GB-102DRUGIntravitreal injection of GB-102
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Eligibility Criteria
Age Range21 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Males or females ≥ 21 years of age * Known diagnosis of macular edema secondary to diabetic macular edema or retinal vein occlusion treated with at least 3 prior IVT injections of an anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab) * Demonstrated response to prior an...

Countries:United States
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