DORZOLAMIDE HYDROCHLORIDE · GLAND
Dorzolamide hydrochloride helps patients with open-angle glaucoma or ocular hypertension by lowering elevated pressure within the eye. It is used to manage this pressure, which is a significant risk factor for damage to the optic nerve and loss of the visual field. This medication provides a way to reduce intraocular pressure through topical application.
How DORZOLAMIDE HYDROCHLORIDE Works
This medication works by inhibiting carbonic anhydrase II, an enzyme in the eye that helps produce aqueous humor. By blocking this enzyme, the drug slows the formation of bicarbonate ions and reduces fluid transport, which ultimately lowers the pressure inside the eye.
Details
- Status
- Prescription
- First Approved
- 1994-12-09
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS
Companies
DORZOLAMIDE HYDROCHLORIDE Approval History
What DORZOLAMIDE HYDROCHLORIDE Treats
2 indicationsDORZOLAMIDE HYDROCHLORIDE is approved for 2 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
DORZOLAMIDE HYDROCHLORIDE 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 DORZOLAMIDE HYDROCHLORIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications DORZOLAMIDE HYDROCHLORIDE treats. First-in-class if their pivotal trials read out positive.
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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.
DORZOLAMIDE HYDROCHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)Dorzolamide Hydrochloride Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Dorzolamide Hydrochloride Ophthalmic Solution is a carbonic anhydrase inhibitor indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
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Full clinical data, patents, trials, and competitive landscape for dorzolamide hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.