Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Oral BGE-102
BGE-102 · 2 trials · 2 indications
Change from Baseline in BCVA as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) in the Study Eye
Percent change in hsCRP of the BGE-102 Dose A daily compared to Placebo
Percent change in hsCRP of the BGE-102 Dose B daily compared to Placebo
Percent change in hsCRP of the BGE-102 Dose C daily compared to Placebo
| Arm | Type | Description |
|---|---|---|
| Arm A: BGE-102 Monotherapy | EXPERIMENTAL | BGE-102 Capsules dosed once daily in combination with Sham intravitreal injection delivered every 4 weeks |
| Arm B: BGE-102 and anti-VEGF Combination Therapy | EXPERIMENTAL | BGE-102 Capsules dosed once daily in combination with anti-VEGF intravitreal injection delivered every 4 weeks |
| Arm C: anti-VEGF Monotherapy | ACTIVE_COMPARATOR | Placebo Capsules dosed once daily in combination with anti-VEGF intravitreal injection delivered every 4 weeks |
| Arm A: BGE-102 Dose A | EXPERIMENTAL | capsules dosed once daily in the morning |
| Arm B: BGE-102 Dose B | EXPERIMENTAL | capsules dosed once daily in the morning |
| Arm C: BGE-102 Dose C | EXPERIMENTAL | capsules dosed once daily in the morning |
| Arm D: Dose D | PLACEBO_COMPARATOR | capsules dosed once daily in the morning |
| Name | Type | Description |
|---|---|---|
| Oral BGE-102 | DRUG | Capsules |
| Oral Placebo Matching BGE-102 | DRUG | Capsules |
| Anti-VEGF | DRUG | intravitreal injection |
| Sham | OTHER | intravitreal injection |
Inclusion Criteria: * Adults 18-75 years of age * Type 1 or Type 2 Diabetes diagnosis * Diabetic Macular Edema (DME) affecting the center of vision * Study Eye may be treatment naïve (never received treatment) or previously treated and if previously treated, meets washout requirements * Acceptable ...
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 |
BGE-102 is an oral small molecule NLRP3 inhibitor being developed by BioAge Labs, Inc. It is in Phase 2 clinical development for diabetic macular edema and for obesity with cardiovascular risk factors. It is an investigational drug and has not been approved by the FDA.
BGE-102 is being studied as an oral treatment for center-involved diabetic macular edema. A randomized, double-blind, active-controlled Phase 2 trial, NCT07812090, is recruiting 180 participants aged 18 and older in the United States to evaluate the drug in this indication.
BGE-102 targets NLRP3, part of the inflammasome pathway, and acts as an inhibitor of it. By inhibiting NLRP3, the oral small molecule is designed to reduce inflammation-driven pathology. This mechanism is being explored in both diabetic macular edema and obesity with cardiovascular risk factors.
BGE-102 is developed by BioAge Labs, Inc., which trades under the ticker BIOA. The company is running the clinical program for the drug, including a Phase 2 study in diabetic macular edema and a Phase 2 study in obesity with cardiovascular risk factors.
BGE-102 is in Phase 2 clinical development. One Phase 2 trial in diabetic macular edema is currently recruiting, and a second Phase 2 trial in obesity with cardiovascular risk factors is active but not recruiting. The drug remains investigational and has not received FDA approval.
BGE-102 is being evaluated in two Phase 2 trials. NCT07812090 is a randomized, double-blind, active-controlled study in center-involved diabetic macular edema recruiting 180 participants in the United States. NCT07656727 is a Phase 2 study of pharmacodynamics, safety and tolerability in 160 participants with obesity and cardiovascular risk factors in the United States and Puerto Rico.
Yes, Oral BGE-102 refers to the same investigational drug as BGE-102. The oral designation reflects its route of administration, as BGE-102 is an orally administered small molecule NLRP3 inhibitor developed by BioAge Labs, Inc. for diabetic macular edema and for obesity with cardiovascular risk factors.