Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
0.2% brimonidine/0.5% timolol fixed combination · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | 0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution |
| 2 | ACTIVE_COMPARATOR | Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution |
| 3 | ACTIVE_COMPARATOR | 0.2% brimonidine ophthalmic solution |
| Name | Type | Description |
|---|---|---|
| 0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution | DRUG | 0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening) |
| Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution | DRUG | Brimonidine 0.2% 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and concurrent timolol 0.5% ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening) |
| Brimonidine 0.2% ophthalmic solution | DRUG | Brimonidine 0.2% ophthalmic solution 1 drop instilled in each eye three times daily (morning, afternoon, and evening) |
Inclusion Criteria: * Diagnosis of ocular hypertension or glaucoma * Patient requires IOP-lowering therapy in both eyes Exclusion Criteria: * Uncontrolled medical conditions * Contraindication to β-adrenoceptor antagonist therapy or brimonidine therapy
Top 4 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Glaukos Corp | GKOS | 5 | PHASE3 | Gen 2 Travoprost Intracameral, Travoprost |
| AbbVie, Inc. | ABBV | 2 | PHASE3 | AGN-193408 |
| SpyGlass Pharma, Inc. | SGP | 4 | PHASE3 | Bimatoprost System |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 1 | PHASE3 | Bimatoprost ophthalmic solution |
It is a fixed-combination ophthalmic solution containing 0.2% brimonidine and 0.5% timolol, developed by AbbVie Inc. (ABBV). It is being studied for the treatment of glaucoma and ocular hypertension, combining two active agents in a single eye drop formulation.
It is used for the treatment of glaucoma and ocular hypertension. A Phase 3 study enrolled patients with these conditions to evaluate the fixed combination. The product is an ophthalmic solution containing 0.2% brimonidine and 0.5% timolol.
AbbVie Inc. (ticker ABBV) is the developer of the 0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution. The company sponsored the Phase 3 clinical trial evaluating the product in patients with glaucoma or ocular hypertension.
The 0.2% brimonidine/0.5% timolol fixed combination is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. It is an investigational product and has not been approved by the FDA.
The fixed combination has been studied in one completed Phase 3 trial, NCT00652106, titled Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension. The randomized, double-blind, active-controlled trial enrolled 432 patients in the United States.