Overview
Dorzolamide is a non-bacteriostatic sulfonamide derivative and topical carbonic anhydrase (CA) inhibitor that treats elevated intraocular pressure (IOP) associated with open-angle glaucoma and ocular hypertension. It works by blocking an enzyme in the ciliary process that regulates ion balance and fluid pressure in the eyes. Unlike oral CA inhibitors, dorzolamide has negligible effects of acid-base or electrolyte disturbances and other systemic adverse effects. First marketed in 1995, dorzolamide is available in ophthalmic solutions as monotherapy marketed as Trusopt or in combination with timolol as Cosopt PF.
Background
Dorzolamide is a non-bacteriostatic sulfonamide derivative and topical carbonic anhydrase (CA) inhibitor that treats elevated intraocular pressure (IOP) associated with open-angle glaucoma and ocular hypertension. It works by blocking an enzyme in the ciliary process that regulates ion balance and fluid pressure in the eyes. Unlike oral CA inhibitors, dorzolamide has negligible effects of acid-base or electrolyte disturbances and other systemic adverse effects. First marketed in 1995, dorzolamide is available in ophthalmic solutions as monotherapy marketed as Trusopt or in combination with timolol as Cosopt PF.
Indication
Dorzolamide is indicated for the management of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. It can also be used in combination with timolol for the same indication in patients who are insufficiently responsive to ophthalmic beta-blockers. Its pre-operative use was also investigated to prevent elevated intraocular pressure after neodynium yttrium aluminum garnet laser posterior capsulotomy.
Associated Conditions
- Increased Intra Ocular Pressure (IOP)
- Ocular Hypertension
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/12/20 | Phase 2 | Not yet recruiting | Kukje Pharma | ||
2023/08/02 | Phase 3 | Completed | Jadran Galenski laboratorij d.d. | ||
2023/08/02 | Phase 3 | Completed | Jadran Galenski laboratorij d.d. | ||
2023/05/12 | Phase 4 | Completed | Laboratorios Poen | ||
2021/10/19 | Phase 2 | UNKNOWN | |||
2020/12/19 | Phase 4 | Withdrawn | |||
2019/05/29 | Phase 4 | Completed | Afyon Kocatepe University Hospital | ||
2015/08/13 | Not Applicable | Completed | Glostrup University Hospital, Copenhagen | ||
2015/03/17 | Phase 3 | Completed | |||
2015/01/06 | N/A | Completed | Applied Genetic Technologies Corp |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bausch & Lomb Incorporated | 24208-485 | OPHTHALMIC | 20 mg in 1 mL | 12/31/2022 | |
| Leading Pharma, LLC | 69315-305 | OPHTHALMIC | 20 mg in 1 mL | 2/28/2022 | |
| Sandoz Inc | 61314-030 | OPHTHALMIC | 20 mg in 1 mL | 9/28/2017 | |
| ImprimisRx NJ | 70261-520 | OPHTHALMIC | 20 mg in 1 mL | 5/8/2018 | |
| Leading Pharma, LLC | 69315-304 | OPHTHALMIC | 20 mg in 1 mL | 1/13/2021 | |
| A-S Medication Solutions | 50090-6814 | OPHTHALMIC | 22.3 mg in 1 mL | 11/25/2021 | |
| A-S Medication Solutions | 50090-4882 | OPHTHALMIC | 20 mg in 1 mL | 11/26/2021 | |
| ImprimisRx NJ | 70261-519 | OPHTHALMIC | 20 mg in 1 mL | 5/8/2018 | |
| Bryant Ranch Prepack | 72162-2184 | OPHTHALMIC | 20 mg in 1 mL | 12/11/2023 | |
| FDC Limited | 55545-1007 | OPHTHALMIC | 20 mg in 1 mL | 11/15/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| COSOPT OPHTHALMIC SOLUTION | SIN11643P | SOLUTION | 2% | 8/22/2001 | |
| ZOLICHEK-T EYE DROPS SOLUTION | SIN14984P | SOLUTION, STERILE | 20mg/ml | 4/8/2016 | |
| DORZOLAMIDE AND TIMOLOL STADA EYE DROPS 20MG/5MG | SIN14556P | SOLUTION, STERILE | 20mg/ml | 6/3/2014 | |
| COSOPT-S OPHTHALMIC SOLUTION | SIN15435P | SOLUTION, STERILE | 20mg/ml | 2/26/2018 | |
| LAMISOPT PLUS EYE DROPS, SOLUTION 20 MG/ML + 5 MG/ML | SIN14903P | SOLUTION | 20 mg/ml | 12/15/2015 | |
| ZOLICHEK EYE DROPS SOLUTION 2% | SIN14985P | SOLUTION, STERILE | 20mg/ml | 4/8/2016 | |
| LAMISOPT EYE DROPS, SOLUTION 20 MG/ML | SIN14893P | SOLUTION | 20.000 mg/ ml | 11/5/2015 | |
| TRUSOPT OPHTHALMIC SOLUTION 2% | SIN08880P | SOLUTION | 2% | 8/28/1996 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||