Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GB-102 · 2 trials · 3 indications
Number of subjects with an adverse event across all study visits
Number of adverse events in total and number of subjects with an adverse event
Mean change from Baseline at Day 270 (Month 9) in best corrected visual acuity (BCVA) measured by early treatment diabetic retinopathy (ETDRS)
| Arm | Type | Description |
|---|---|---|
| GB-102 Dose 1 (1 mg) | EXPERIMENTAL | Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline. |
| GB-102 Dose 2 (2 mg) | EXPERIMENTAL | Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline. |
| Experimental: Phase 1 - GB-102 | EXPERIMENTAL | Subjects will be assigned to 1 of 4 cohorts to receive a single intravitreal injection of up to 2.0 mg (50 μL) GB-102. |
| Experimental: Phase 2 - GB-102 | EXPERIMENTAL | Low dose or high dose injected every 6 months |
| Active Comparator: Phase 2 - Aflibercept | ACTIVE_COMPARATOR | Aflibercept 2 mg injected every 2 months |
| Name | Type | Description |
|---|---|---|
| GB-102 | DRUG | Intravitreal injection of GB-102 |
| Aflibercept | DRUG | Intravitreal injection of Aflibercept. |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901, Aflibercept |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Oculis Holding AG | OCS | 2 | PHASE3 | Dexamethasone, Vehicle |
| AbbVie, Inc. | ABBV | 3 | PHASE2 | ABBV-RGX-314 Dose 1, Steroid, Aflibercept |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | bevacizumab |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-150 IVT, Aflibercept IVT |
| Alvotech | ALVO | 1 | PHASE3 | AVT29, Eylea HD |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 Dose 1, RGX-314 Dose 2, Aflibercept |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
GB-102 is an investigational small molecule being developed for diabetic macular edema and neovascular age-related macular degeneration. It is a depot formulation of sunitinib malate designed for intravitreal injection. The drug is currently in Phase 2 clinical development and has not been approved by the FDA.
GB-102 is being developed by LENZ Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol LENZ. The company is conducting clinical trials of GB-102 in the United States for ophthalmology indications.
GB-102 is in Phase 2 clinical development. It has completed a Phase 1 trial and a Phase 2 trial, both in the United States. The drug is investigational and has not received FDA approval for any indication.
GB-102 has been studied in two completed clinical trials. NCT03249740 was a Phase 1 trial in neovascular age-related macular degeneration with 32 participants. NCT04085341 was a Phase 2 trial in diabetic macular edema and retinal vein occlusion with 21 participants. Both trials were conducted in the United States.
GB-102 is a depot formulation of sunitinib malate, a small molecule that inhibits multiple receptor tyrosine kinases involved in angiogenesis. By delivering sustained levels of sunitinib locally in the eye, GB-102 is designed to block vascular endothelial growth factor and other pro-angiogenic pathways that drive retinal disease.