Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Brimonidine, 0.2% · 7 trials · 2 indications
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Diurnal IOP was defined as the average of the three timepoints measured: 9 AM, +2 Hrs and +7Hrs. Baseline was the average of the values for 2 eligibility visits. If one of the values was missing, the other non-missing value was taken as the baseline. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement, ie, a reduction of IOP. Only one eye (study eye) contributed to the analysis.
The study drug was instilled at 8 AM and 3 PM (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
At the Month 3 (Exit) visit, the 8 am IOP measurement was taken before instillation of study drug. The study drug was instilled approximately 15 minutes after the 8 am measurement. An additional dose was given at 3 pm. Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Ocular discomfort was assessed by the subject immediately following the 8 AM instillation of study drug and rated on a 5-point scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe).
| Arm | Type | Description |
|---|---|---|
| Brinz/Brim | EXPERIMENTAL | Vehicle solution, 1 drop, followed by Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) twice daily (BID) for 3 months |
| Brinz+Brim | ACTIVE_COMPARATOR | Brimonidine 2 mg/mL eye drops, solution, 1 drop, followed by Brinzolamide 10 mg/mL eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) BID for 3 months |
| Brinz | ACTIVE_COMPARATOR | Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months |
| Brim | ACTIVE_COMPARATOR | Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months |
| Brinzolamide | ACTIVE_COMPARATOR | Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months |
| Brimonidine | ACTIVE_COMPARATOR | Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months |
| Brinzolamide/Brimonidine | EXPERIMENTAL | Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day for 3 months |
| Name | Type | Description |
|---|---|---|
| Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension | DRUG | - |
| Brinzolamide 10 mg/mL eye drops, suspension | DRUG | - |
| Brimonidine 2 mg/mL eye drops, solution | DRUG | - |
| Vehicle | DRUG | Inactive ingredients used as a placebo for masking purposes |
| Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension | DRUG | - |
| Brinzolamide 1% ophthalmic suspension | DRUG | - |
| Brimonidine tartrate 0.2% ophthalmic solution | DRUG | - |
| Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension | DRUG | - |
| Brinzolamide ophthalmic suspension, 1% | DRUG | - |
| Brimonidine tartrate ophthalmic solution, 0.2% | DRUG | - |
| Brimonidine Tartrate Ophthalmic Solution | DRUG | - |
Inclusion Criteria: * Diagnosis of open-angle glaucoma or ocular hypertension insufficiently controlled on monotherapy or currently on multiple IOP-lowering medications; * Mean IOP measurements within guidelines specified in the protocol. Must not be \> 36 mmHg at any time point; * Able to understa...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Glaukos Corp | GKOS | 3 | PHASE4 | Travoprost Intraocular |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 1 | PHASE4 | Test - Bimatoprost 0.01%, Reference - LUMIGAN |
| AbbVie, Inc. | ABBV | 1 | PHASE4 | Bimatoprost |
| United Therapeutics Corporation | UTHR | 1 | PHASE4 | Nicotinomide |
| Alcon AG | ALC | 3 | PHASE4 | Undisclosed |
Brimonidine 0.2% is an ophthalmic small molecule used to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension. It is being developed by Alcon Inc. (NYSE: ALC) and is currently in Phase 3 clinical development as part of fixed-dose combination therapies with brinzolamide.
Brimonidine is a selective alpha-2 adrenergic receptor agonist. By stimulating these receptors in the eye, it reduces aqueous humor production and increases uveoscleral outflow, thereby lowering intraocular pressure. This mechanism is being evaluated in combination with brinzolamide, a carbonic anhydrase inhibitor, in Phase 3 trials.
Brimonidine 0.2% is being developed by Alcon Inc., a Swiss ophthalmic company traded on the New York Stock Exchange under the ticker ALC. Alcon is conducting Phase 3 clinical trials to evaluate the efficacy and safety of brimonidine 0.2% in fixed-dose combinations with brinzolamide for open-angle glaucoma.
Brimonidine 0.2% is in Phase 3 clinical development. Alcon has completed seven trials involving 4,614 patients, with all trials completed and none currently active. The Phase 3 studies are evaluating the fixed-dose combination of brinzolamide 1% and brimonidine 0.2% against its individual components.
Brimonidine 0.2% has been studied in several completed Phase 3 trials, including NCT01297517 (1,001 patients), NCT01309204 (1,184 patients), and NCT02339584 (493 patients). These randomized, double-blind, active-controlled trials compared the brinzolamide/brimonidine fixed combination to brinzolamide alone or in combination with brimonidine in patients with open-angle glaucoma or ocular hypertension.
Brimonidine 0.2% refers to the concentration of brimonidine, which is typically formulated as brimonidine tartrate in ophthalmic solutions. The clinical trials listed use brimonidine 0.2% as the active ingredient, and the drug is being studied in combination with brinzolamide 1% for the treatment of open-angle glaucoma and ocular hypertension.