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Mydriatics
Mydriatics is a Small molecule drug developed by Laboratoires Thea. It is currently in Phase 3 development. Also known as: Tropicamide, Phenylpehrine.
Mydriatics are substances that cause the dilation of the pupil, often used to treat or diagnose conditions such as myopia and myopia progression. They are also studied in clinical trials for various conditions including Type 1 Diabetes, Type 2 Diabetes, Cystic Fibrosis-related Diabetes, and myopia.
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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 | Mydriatics |
|---|---|
| Also known as | Tropicamide, Phenylpehrine |
| Sponsor | Laboratoires Thea |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Comparison of 4 Methods of Eye Drops for Pupil Dilation in Diabetic Patients (NA)
- ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2 (NA)
- The P.A.U.S.E.® Spectacle Study (NA)
- Optical Correction and Visual Functions of Adults With Amblyopia (NA)
- OPTDR01 Feasibility for Automated Diabetic Retinopathy Detection
- Implementation of Teleophthalmology in Urban Health Systems Study (NA)
- Oral Prednisolone Versus Posterior Sub-Tenon Triamcinolone for Acute Ocular VKH
- Sublingual Atropine Bioequivalence by Route of Administration (SABER) (PHASE1)
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:
- Mydriatics CI brief — competitive landscape report
- Mydriatics updates RSS · CI watch RSS
- Laboratoires Thea portfolio CI
Frequently asked questions about Mydriatics
What is Mydriatics?
Who makes Mydriatics?
Is Mydriatics also known as anything else?
What development phase is Mydriatics in?
Related
- Manufacturer: Laboratoires Thea — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Tropicamide, Phenylpehrine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing