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Drug: GB-102

Phase 2

Neovascular Age-Related Macular Degeneration | Small molecule | Ophthalmology |LENZ Therapeutics, Inc.|Last Updated: Jan 19, 2022

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
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03953079A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMDPHASE2 COMPLETED 56 — — Sep 26, 2019Jun 3, 2021Jan 19, 202233 United States
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Study Endpoints
Primary Endpoints
Time to First Rescue Treatment
Baseline through 12 months

Kaplan-Meier estimate of the median time to first rescue treatment.

Secondary Endpoints
Time to Fulfillment of at Least One Rescue Criterion
6 months through 12 months
Number of Times That at Least One Rescue Criterion is Met
Baseline through 12 months
Number of Treatments, Including Both Rescue and Scheduled Study Treatments, During the Study
Baseline through 12 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GB-102 1 mg/1 mgEXPERIMENTALParticipants will receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
GB-102 2 mg/1 mgEXPERIMENTALParticipants will receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
Aflibercept 2 mgACTIVE_COMPARATORParticipants will receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
Interventions
NameTypeDescription
Drug: GB-102DRUGIntravitreal injection of GB-102
AfliberceptDRUGIntravitreal injection of aflibercept (2 mg dose)
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Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites33

Inclusion Criteria: * Males or females ≥ 50 years of age * Presence of a choroidal neovascularization (CNV) lesion secondary to AMD treated with at least 3 prior intravitreal (IVT) injections of an anti-vascular endothelial growth factor (VEGF) agent (aflibercept, bevacizumab, or ranibizumab). * De...

Countries:United States
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