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Proxymetacaine
Proxymetacaine is a Small molecule drug developed by Medical University of Silesia. It is currently in Phase 1 development for Administration of Corneal Anesthesia, Local Anesthesia for Ophthalmologic Procedure. Also known as: Alcaine.
Proxymetacaine is a small molecule topical anesthetic drug of the aminoester group. It has been studied in clinical trials for various retinal diseases, including macular edema, fibrosis of the retina, and glaucoma.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Proxymetacaine |
|---|---|
| Also known as | Alcaine |
| Sponsor | Medical University of Silesia |
| Target | Amine oxidase [flavin-containing] A, Sigma non-opioid intracellular receptor 1, Sodium channel protein type 10 subunit alpha |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 1 |
Approved indications
- Administration of Corneal Anesthesia
- Local Anesthesia for Ophthalmologic Procedure
Common side effects
Key clinical trials
- Study Evaluating the Efficacy and Safety of Chloroprocaine HCl Ophthalmic Gel 3% vs Proparacaine Ophthalmic Solution 0.5% Plus Subconjunctival Lidocaine in Patients Undergoing Intravitreal Injections (PHASE4)
- Efficacy of Nanodropper-mediated Topical Anesthetic (PHASE4)
- Neurosensory Abnormalities in SymptomAtic Ocular Surface Patients (NASA)
- Study of Stimulus Parameters in Flicker Electroretinogram (ERG) (NA)
- Subthreshold Micropulse Laser Therapy (SML) in Retinitis Pigmentosa (NA)
- An Investigation of the Impact of Localized Topical Anesthesia of the Ocular Surface on End-of-day Contact Lens Discomfort (NA)
- Optic Nerve Head Structural Response to IOP Elevation in Patients With Keratoconus (NA)
- Base Curves of Bandage Contact Lenses and Their Effects on Post Trans-PRK Vision and Pain (NA)
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:
- Proxymetacaine CI brief — competitive landscape report
- Proxymetacaine updates RSS · CI watch RSS
- Medical University of Silesia portfolio CI
Frequently asked questions about Proxymetacaine
What is Proxymetacaine?
What is Proxymetacaine used for?
Who makes Proxymetacaine?
Is Proxymetacaine also known as anything else?
What development phase is Proxymetacaine in?
What does Proxymetacaine target?
Related
- Target: All drugs targeting Amine oxidase [flavin-containing] A, Sigma non-opioid intracellular receptor 1, Sodium channel protein type 10 subunit alpha
- Manufacturer: Medical University of Silesia — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Administration of Corneal Anesthesia
- Indication: Drugs for Local Anesthesia for Ophthalmologic Procedure
- Also known as: Alcaine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing