COSOPT PF (dorzolamide hydrochloride)
COSOPT PF is a fixed-dose combination of dorzolamide hydrochloride (a carbonic anhydrase inhibitor) and timolol maleate (a non-selective beta-adrenergic receptor blocking agent). 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 levels despite beta-blocker monotherapy. This combination therapy provides a greater reduction in IOP than either component used alone, though the reduction is slightly less than that achieved by concomitant administration of the individual components at their standard dosing frequencies (dorzolamide TID and timolol BID).
How COSOPT PF Works
COSOPT PF reduces elevated intraocular pressure by decreasing the secretion of aqueous humor through two distinct mechanisms. Dorzolamide hydrochloride 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 maleate is a non-selective beta-adrenergic receptor blocking agent that further reduces aqueous humor secretion. Together, these agents lower IOP, addressing a major risk factor for optic nerve damage and glaucomatous visual field loss.
Details
- Status
- Prescription
- First Approved
- 2012-02-01
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS
COSOPT PF Approval History
What COSOPT PF Treats
2 indicationsCOSOPT PF is approved for 2 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Glaucoma
- Ocular Hypertension
COSOPT PF Competitive Set
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Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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 PF's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications COSOPT PF treats. First-in-class if their pivotal trials read out positive.
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Active Pipeline
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Key Completed Trials
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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 PF FDA Label Details
Indications & Usage
FDA Label (PDF)COSOPT PF 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.