Approval Probability
TA Base Rate
Adjusted LOA
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Drug: GB-102 · 1 trial · 1 indication
Kaplan-Meier estimate of the median time to first rescue treatment.
| Arm | Type | Description |
|---|---|---|
| GB-102 1 mg/1 mg | EXPERIMENTAL | Participants 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 mg | EXPERIMENTAL | Participants 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 mg | ACTIVE_COMPARATOR | Participants will receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10. |
| Name | Type | Description |
|---|---|---|
| Drug: GB-102 | DRUG | Intravitreal injection of GB-102 |
| Aflibercept | DRUG | Intravitreal injection of aflibercept (2 mg dose) |
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...
GB-102 is an investigational small molecule being developed for the treatment of neovascular age-related macular degeneration (wet AMD). It is a depot formulation of sunitinib malate, designed for intravitreal injection to treat this retinal condition. The drug is currently in clinical development and is not yet approved by regulatory authorities.
GB-102 is a depot formulation of sunitinib malate, a small molecule that inhibits multiple receptor tyrosine kinases involved in angiogenesis. By targeting these pathways, GB-102 is intended to reduce abnormal blood vessel growth and vascular permeability in the eye, which are hallmarks of neovascular age-related macular degeneration.
GB-102 is being developed by LENZ Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol LENZ. The company is advancing this investigational therapy for neovascular age-related macular degeneration through clinical development.
GB-102 is in Phase 2 clinical development. It has completed one Phase 2 trial, which was an active-controlled study comparing GB-102 to aflibercept in patients with wet AMD. The drug remains investigational and has not received FDA approval.
GB-102 has been studied in one completed Phase 2 clinical trial, identified as NCT03953079. This trial, titled 'A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD,' enrolled 56 participants in the United States. The study was active-controlled and included patients aged 50 years and older.
GB-102 is a depot formulation of sunitinib malate, meaning it contains the same active pharmaceutical ingredient but in a sustained-release formulation designed for intravitreal injection. This depot formulation is intended to provide prolonged drug exposure in the eye compared to standard sunitinib, which is typically administered systemically for cancer indications.