COSOPT (dorzolamide hydrochloride)
Cosopt is a fixed-combination ophthalmic solution containing dorzolamide hydrochloride (a carbonic anhydrase inhibitor) and timolol maleate (a non-selective beta-adrenergic receptor blocker). It is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who have not achieved target IOP goals with beta-blocker monotherapy. While Cosopt administered twice daily provides a greater reduction in IOP than either component used alone, the reduction is slightly less than that achieved by the concomitant administration of dorzolamide 2% (three times daily) and timolol 0.5% (twice daily).
How COSOPT Works
Cosopt reduces elevated IOP by decreasing aqueous humor secretion through two distinct pharmacological pathways. Dorzolamide inhibits human carbonic anhydrase II in the ciliary processes of the eye, slowing the formation of bicarbonate ions and subsequently reducing sodium and fluid transport. Timolol is a non-selective beta-1 and beta-2 adrenergic receptor blocking agent that further decreases aqueous humor production. By lowering internal pressure, the combination helps mitigate the risk of pathogenesis in optic nerve damage and glaucomat
Details
- Status
- Prescription
- First Approved
- 1998-04-07
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS
COSOPT Approval History
What COSOPT Treats
2 indicationsCOSOPT is approved for 2 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Glaucoma
- Ocular Hypertension
COSOPT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in COSOPT's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications COSOPT treats. First-in-class if their pivotal trials read out positive.
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Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00767481 | C-08-16 2008-002781-66 | Ph 3 | terminated | 1 Year Study Trav/Brinz QD Fixed Combination Versus COSOPT |
| NCT00761995 | MA-CT-08-003 | Ph 4 | completed | Safety and Efficacy of Brinzolamide Dosed TID With Dorzolamide Dosed TID in Reducing Intraocular Pressure in Patients With Open Angle Glaucoma or Ocular Hypertension |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
COSOPT FDA Label Details
Indications & Usage
FDA Label (PDF)COSOPT is indicated for the treatment of Glaucoma; Ocular Hypertension.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.