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Brinzolamide/Timolol · 10 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).
Mean diurnal IOP change from baseline at Week 8 (ie, the subject IOP change from baseline averaged over the 9 AM, 11AM and 5 PM time points at Week 8) was measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement..
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 |
| AZARGA | EXPERIMENTAL | Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator. |
| AZOPT + Timolol | ACTIVE_COMPARATOR | Brinzolamide 1% ophthalmic suspension, 1 drop instilled in the affected eye(s), followed by Timolol 0.5% ophthalmic solution, 1 drop instilled in the affected eye(s). Approximately 10 minutes separated the 2 instillations. The study drugs were instilled twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator. |
| Brinzolamide +Timolol | EXPERIMENTAL | - |
| Timolol | ACTIVE_COMPARATOR | - |
| Brinzolamide + Timolol | EXPERIMENTAL | - |
| Dorzolamide + Timolol | ACTIVE_COMPARATOR | - |
| 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 | - |
| Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension | DRUG | - |
| Timolol 0.5% ophthalmic solution | DRUG | - |
| Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension | DRUG | One drop twice daily in each study eye for six months |
| Brinzolamide 10 mg/ml (AZOPT) eye drops, suspension | DRUG | One drop twice daily in each study eye for six months |
| Timolol 5 mg/ml eye drops, solution | DRUG | One drop twice daily in each study eye for six months |
| Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (COSOPT) | DRUG | One drop in the study eye(s) twice daily for 12 months |
| Brinzolamide/Timolol | 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...
Top 3 of 5 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Glaukos Corp | GKOS | 3 | PHASE4 | Travoprost Intraocular, high elution |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 1 | PHASE4 | Bimatoprost ophthalmic solution |
| AbbVie, Inc. | ABBV | 1 | PHASE4 | bimatoprost |
Brinzolamide/Timolol is used for open-angle glaucoma. It is a fixed combination ophthalmic suspension developed to lower intraocular pressure in patients with this condition. The clinical program also enrolled patients with ocular hypertension alongside open-angle glaucoma in its trials.
Brinzolamide/Timolol targets carbonic anhydrase 2 (CA2) as an inhibitor. Brinzolamide is the carbonic anhydrase inhibitor component of the fixed combination, and the product is formulated as a small molecule ophthalmic suspension for topical eye administration.
Brinzolamide/Timolol is developed by Alcon Inc., which trades under the ticker ALC. Alcon is the sponsor behind the clinical development program for this fixed combination ophthalmic product.
Brinzolamide/Timolol is in Phase 3 development. It is an investigational fixed combination ophthalmic suspension, and the program includes completed Phase 2 and Phase 3 trials. Ten trials in total have been completed, with no active trials currently listed.
Completed trials include NCT01357616, a Phase 3 study of brinzolamide 1%/timolol 0.5% versus the individual components in open-angle glaucoma or ocular hypertension. Other completed studies include NCT02339584, NCT01310777, and the Phase 2 comfort study NCT01426867. Across the program, 5,990 participants were enrolled.