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Dorzolamide 2 % eye drops solution
Dorzolamide 2 % eye drops solution is a Carbonic anhydrase inhibitor Small molecule drug developed by Alfred E. Tiefenbacher (GmbH & Co. KG). It is currently in Phase 3 development for Glaucoma, Ocular hypertension.
Dorzolamide inhibits carbonic anhydrase II in the eye to reduce aqueous humor production and lower intraocular pressure.
Dorzolamide inhibits carbonic anhydrase II in the eye to reduce aqueous humor production and lower intraocular pressure. Used for Glaucoma, Ocular hypertension.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Dorzolamide 2 % eye drops solution |
|---|---|
| Sponsor | Alfred E. Tiefenbacher (GmbH & Co. KG) |
| Drug class | Carbonic anhydrase inhibitor |
| Target | Carbonic anhydrase II |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
Carbonic anhydrase II is an enzyme that catalyzes the production of aqueous humor in the ciliary body of the eye. By inhibiting this enzyme, dorzolamide decreases aqueous humor secretion, which reduces intraocular pressure. This mechanism makes it effective for treating glaucoma and ocular hypertension, conditions where elevated intraocular pressure can damage the optic nerve.
Approved indications
- Glaucoma
- Ocular hypertension
Common side effects
- Ocular irritation or discomfort
- Blurred vision
- Bitter taste
- Allergic conjunctivitis
- Corneal erosion
Key clinical trials
- Efficacy of Simbrinza and Rocklatan vs Cosopt and Latanoprost (PHASE4)
- PRO-122 Versus Concomitant Therapy in Subjects With Uncontrolled Primary Open-angle Glaucoma (PRO-122LATAM) (PHASE3)
- Dorzolamide+Timolol Multidose Preservative-free vs Dorzolamida+Timolol BAK Preserved Efficacy and Safety (PHASE4)
- Comparative Study of the Efficacy of Either Krytantek Ofteno PF® or Eliptic Ofteno PF® Plus Gaap Ofteno PF® for POAG or Ocular Hypertension. (PHASE4)
- Augmented Macular Pigment-containing Nutraceutical and Central Visual Function (PHASE4)
- Combined Intravitreal Bevacizumab With Topical Timolol-Dorzolamide Eye Drops in Diabetic Macular Edema (PHASE2, PHASE3)
- Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-122 Compared With Krytantek Ofteno® (PHASE1)
- Non-inferiority of PRO-122 Ophthalmic Solution vs KRYTANTEK Ofteno® in Glaucoma or Ocular Hypertension (CONFORTK) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Dorzolamide 2 % eye drops solution CI brief — competitive landscape report
- Dorzolamide 2 % eye drops solution updates RSS · CI watch RSS
- Alfred E. Tiefenbacher (GmbH & Co. KG) portfolio CI
Frequently asked questions about Dorzolamide 2 % eye drops solution
What is Dorzolamide 2 % eye drops solution?
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Who makes Dorzolamide 2 % eye drops solution?
What drug class is Dorzolamide 2 % eye drops solution in?
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What are the side effects of Dorzolamide 2 % eye drops solution?
What does Dorzolamide 2 % eye drops solution target?
Related
- Drug class: All Carbonic anhydrase inhibitor drugs
- Target: All drugs targeting Carbonic anhydrase II
- Manufacturer: Alfred E. Tiefenbacher (GmbH & Co. KG) — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Glaucoma
- Indication: Drugs for Ocular hypertension
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing