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Fixed-Combination Bimatoprost/Brimonidine · 1 trial · 2 indications
IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).
| Arm | Type | Description |
|---|---|---|
| Fixed-Combination Bimatoprost/Brimonidine | EXPERIMENTAL | One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks. |
| Bimatoprost Ophthalmic Solution 0.01% and Vehicle | ACTIVE_COMPARATOR | One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks. |
| Brimonidine Tartrate Ophthalmic Solution 0.2% | ACTIVE_COMPARATOR | One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks. |
| Name | Type | Description |
|---|---|---|
| Fixed-Combination Bimatoprost/Brimonidine | DRUG | One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks. |
| Bimatoprost Ophthalmic Solution 0.01% | DRUG | One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening for 6 weeks. |
| Vehicle Ophthalmic Solution | DRUG | One drop vehicle ophthalmic solution in each eye in the morning daily for 6 weeks. |
| Brimonidine Tartrate Ophthalmic Solution 0.2% | DRUG | One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks. |
Inclusion Criteria: * Diagnosis of ocular hypertension or glaucoma * Requires intraocular pressure (IOP)-lowering therapy Exclusion Criteria: * Cataract surgery in one eye * Ocular laser or intraocular surgery within 6 months * Refractive surgery in either eye * Anticipated use of contact lenses ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Glaukos Corp | GKOS | 6 | PHASE3 | Gen 2 Travoprost Intracameral, Timolol eye 0.5% |
| AbbVie, Inc. | ABBV | 2 | PHASE3 | Undisclosed |
| SpyGlass Pharma, Inc. | SGP | 4 | PHASE3 | Bimatoprost System, Timolol, 0.5% |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 2 | PHASE3 | Test- Bimatoprost 0.01%, Reference- LUMIGAN |
| Alcon AG | ALC | 5 | N/A | Undisclosed |
| Sight Sciences, Inc. | SGHT | 3 | N/A | Undisclosed |
Fixed-Combination Bimatoprost/Brimonidine is an investigational fixed-dose combination of two small molecules being developed for the treatment of glaucoma. It combines bimatoprost and brimonidine in a single product to lower intraocular pressure in patients with chronic glaucoma or ocular hypertension.
AbbVie Inc. (NYSE: ABBV) is developing Fixed-Combination Bimatoprost/Brimonidine. The company is conducting clinical research on this fixed-dose combination of bimatoprost and brimonidine for the treatment of glaucoma.
Fixed-Combination Bimatoprost/Brimonidine is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the drug remains under clinical investigation for glaucoma.
Fixed-Combination Bimatoprost/Brimonidine was studied in a completed Phase 2 trial, NCT01863953, which evaluated its safety and efficacy in chronic glaucoma or ocular hypertension. The randomized, double-blind, active-controlled study enrolled 112 participants in the United States, with a minimum age of 40 years.
Fixed-Combination Bimatoprost/Brimonidine combines bimatoprost, a prostaglandin analog, and brimonidine, an alpha-2 adrenergic agonist. These two active ingredients work through different mechanisms to reduce intraocular pressure, which is elevated in glaucoma. The fixed-dose combination aims to provide greater pressure-lowering efficacy than either component alone.