Dorzolamide

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.

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
A Randomized, Open-label, Active-controlled, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of TFC-003 in Patients With Primary Open-angle Glaucoma or Ocular Hypertension	2023/12/20	NCT06177678	Phase 2	Not yet recruiting	Kukje Pharma
Comparative Study of Dorzol Eye Drops, 20 mg/ml Versus Trusopt® Eye Drops, 20 mg/ml	2023/08/02	NCT05973305	Phase 3	Completed	Jadran Galenski laboratorij d.d.
Comparative Study of Dorzotimol Eye Drops, 20 mg/mL + 5 mg/mL Versus Cosopt® Eye Drops, 20 mg/mL + 5 mg/mL	2023/08/02	NCT05973318	Phase 3	Completed	Jadran Galenski laboratorij d.d.
Dorzolamide+Timolol Multidose Preservative-free vs Dorzolamida+Timolol BAK Preserved Efficacy and Safety	2023/05/12	NCT05857267	Phase 4	Completed	Laboratorios Poen
Combined Intravitreal Bevacizumab With Topical Timolol-Dorzolamide Eye Drops in Diabetic Macular Edema	2021/10/19	NCT05083689	Phase 2	UNKNOWN	Shahid Beheshti University of Medical Sciences
Augmented Macular Pigment-containing Nutraceutical and Central Visual Function	2020/12/19	NCT04676126	Phase 4	Withdrawn	University of the Incarnate Word
Choroidal Thickness and Its Correlations With Ocular Parameters in Primary Open-angle Glaucoma	2019/05/29	NCT03966560	Phase 4	Completed	Afyon Kocatepe University Hospital
Pupillary Response After Glaucoma Medication	2015/08/13	NCT02522039	Not Applicable	Completed	Glostrup University Hospital, Copenhagen
Stop Retinal Ganglion Cell Dysfunction Study	2015/03/17	NCT02390284	Phase 3	Completed	University of Miami
Clinical Evaluation of Patients With X-linked Retinoschisis	2015/01/06	NCT02331173	N/A	Completed	Applied Genetic Technologies Corp

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Dorzolamide HCl	Bausch & Lomb Incorporated	24208-485	OPHTHALMIC	20 mg in 1 mL	12/31/2022
Dorzolamide and Timolol	Leading Pharma, LLC	69315-305	OPHTHALMIC	20 mg in 1 mL	2/28/2022
Dorzolamide Hydrochloride and Timolol Maleate	Sandoz Inc	61314-030	OPHTHALMIC	20 mg in 1 mL	9/28/2017
Tim-Brim-Dor PF	ImprimisRx NJ	70261-520	OPHTHALMIC	20 mg in 1 mL	5/8/2018
Dorzolamide hydrochloride	Leading Pharma, LLC	69315-304	OPHTHALMIC	20 mg in 1 mL	1/13/2021
Dorzolamide Hydrochloride and Timolol Maleate ophthalmic	A-S Medication Solutions	50090-6814	OPHTHALMIC	22.3 mg in 1 mL	11/25/2021
Dorzolamide Hydrochloride Ophthalmic	A-S Medication Solutions	50090-4882	OPHTHALMIC	20 mg in 1 mL	11/26/2021
Tim-Dor PF	ImprimisRx NJ	70261-519	OPHTHALMIC	20 mg in 1 mL	5/8/2018
Dorzolamide Hydrochloride and Timolol Maleate	Bryant Ranch Prepack	72162-2184	OPHTHALMIC	20 mg in 1 mL	12/11/2023
Dorzolamide and Timolol	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	Santen Pharmaceutical Co., Ltd. Noto Plant	SIN11643P	SOLUTION	2%	8/22/2001
ZOLICHEK-T EYE DROPS SOLUTION	Indoco Remedies Limited	SIN14984P	SOLUTION, STERILE	20mg/ml	4/8/2016
DORZOLAMIDE AND TIMOLOL STADA EYE DROPS 20MG/5MG	Famar S.A.	SIN14556P	SOLUTION, STERILE	20mg/ml	6/3/2014
COSOPT-S OPHTHALMIC SOLUTION	Santen Pharmaceutical Co., Ltd. Noto Plant	SIN15435P	SOLUTION, STERILE	20mg/ml	2/26/2018
LAMISOPT PLUS EYE DROPS, SOLUTION 20 MG/ML + 5 MG/ML	Rafarm S.A	SIN14903P	SOLUTION	20 mg/ml	12/15/2015
ZOLICHEK EYE DROPS SOLUTION 2%	Indoco Remedies Limited	SIN14985P	SOLUTION, STERILE	20mg/ml	4/8/2016
LAMISOPT EYE DROPS, SOLUTION 20 MG/ML	Rafarm S.A	SIN14893P	SOLUTION	20.000 mg/ ml	11/5/2015
TRUSOPT OPHTHALMIC SOLUTION 2%	Santen Pharmaceutical Co., Ltd. Noto Plant	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.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
COSDOR dorzolamide (as hydrochloride) 20 mg/mL and timolol (as maleate) 5 mg/mL eye drop bottle	217250	Viatris Pty Ltd	Medicine	A	9/25/2014
DORZOLAMIDE/TIMOLOL APOTEX 20/5 dorzolamide/timolol eye drops	267125	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	1/11/2017
TRUSOPTIDE dorzolamide (as hydrochloride) 20 mg/mL eye drops bottle	291440	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/15/2018
DORZOLAMIDE/TIMOLOL JN 20/5 dorzolamide (as hydrochloride) 20 mg/mL and timolol (as maleate) 5 mg/mL eye drops solution bottle	253992	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/14/2016
DORZOTRUS dorzolamide (as hydrochloride) 20 mg/mL eye drops bottle	291436	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/15/2018
DORZOLAMIDE NHPL dorzolamide (as hydrochloride) 20 mg/mL eye drops bottle	291439	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/15/2018
DORZTIMOLOL 20/5 dorzolamide hydrochloride 20 mg and timolol maleate 5 mg per mL eye drop bottle	291375	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	7/23/2018
DORZALAMIDE TIMOL 20/5 dorzolamide hydrochloride 20 mg and timolol maleate 5 mg per mL eye drop bottle	291376	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	7/23/2018
TORZOLAMIDE dorzolamide (as hydrochloride) 20 mg/mL eye drops bottle	291441	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/15/2018
COSOPT dorzolamide hydrochloride 20mg and timolol maleate 5mg per mL eye drop bottle	66103	Mundipharma Pty Ltd	Medicine	A	9/2/1999

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
DORZOLAMIDA/TIMOLOL VIR 20 MG/ML + 5 MG/ML COLIRIO EN SOLUCION	Industria Quimica Y Farmaceutica Vir S.A.	77386	COLIRIO EN SOLUCIÓN	Medicamento Sujeto A Prescripción Médica	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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