Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Sunitinib malate
GB-102 · 3 trials · 3 indications
Number of subjects with an adverse event across all study visits
Kaplan-Meier estimate of the median time to first rescue treatment.
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. |
| 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. |
| 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 |
| Drug: GB-102 | DRUG | Intravitreal injection of GB-102 |
| Aflibercept | DRUG | Intravitreal injection of aflibercept (2 mg dose) |
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...
Top 16 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901 |
| 4D Molecular Therapeutics, Inc. | FDMT | 2 | PHASE3 | 4D-150, EYELEA |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Hoffmann-La Roche | RHHBY | 6 | PHASE3 | Ranibizumab, Susvimo, RO7497372, RO7823653, Faricimab |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | MK-8748 |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | Surabgene Lomparvovec |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | ONS-5010 |
| Kodiak Sciences, Inc. | KOD | 1 | PHASE3 | Tabirafusp tedromer |
| Alvotech | ALVO | 1 | PHASE3 | AVT29 |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 |
| BioAge Labs, Inc. | BIOA | 1 | PHASE2 | BGE-102 |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Surrozen Inc | SRZN | 1 | PHASE1 | SZN-8141 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
| Bayer | BAYRY | 1 | - | Aflibercept |
GB-102 is an investigational small molecule depot formulation of sunitinib malate developed by LENZ Therapeutics, Inc. (ticker: LENZ). It is being studied as an ophthalmology treatment for retinal diseases, specifically diabetic macular edema and neovascular age-related macular degeneration, and has completed Phase 2 clinical testing.
GB-102 is being developed for the treatment of diabetic macular edema, a retinal condition involving fluid accumulation in the macula. It has been evaluated in a completed Phase 2 trial in subjects with diabetic macular edema and retinal vein occlusion. GB-102 is investigational and has not been approved for this use.
GB-102 is developed by LENZ Therapeutics, Inc., which trades under the ticker LENZ. The company has sponsored the clinical trials evaluating this small molecule depot formulation of sunitinib malate in retinal disease indications.
GB-102 has completed Phase 2 clinical development. Two Phase 2 trials and one Phase 1 trial have been completed, with no active trials currently listed. GB-102 remains investigational and has not been approved by the FDA for any indication.
GB-102 has been studied in three completed trials: NCT04085341 in diabetic macular edema and retinal vein occlusion, NCT03953079 comparing GB-102 to aflibercept in wet AMD, and NCT03249740 in neovascular age-related macular degeneration. Total enrollment across these trials was 88 participants.
GB-102 is a depot formulation of sunitinib malate, meaning the active drug substance is sunitinib malate delivered in a sustained-release depot format. GB-102 is the development name used by LENZ Therapeutics for this ophthalmic formulation.