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Hyalein Mini Eye Drops
Hyalein Mini Eye Drops is a Artificial tear / Lubricating eye drop Small molecule drug developed by Huons Co., Ltd.. It is currently in Phase 3 development for Dry eye disease / Keratoconjunctivitis sicca. Also known as: Hyalein Mini 0.3%.
Hyalein Mini Eye Drops is a hyaluronic acid-based lubricating eye drop that provides moisture and protection to the ocular surface.
Hyalein Mini Eye Drops is a hyaluronic acid-based lubricating eye drop that provides moisture and protection to the ocular surface. Used for Dry eye disease / Keratoconjunctivitis sicca.
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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 | Hyalein Mini Eye Drops |
|---|---|
| Also known as | Hyalein Mini 0.3% |
| Sponsor | Huons Co., Ltd. |
| Drug class | Artificial tear / Lubricating eye drop |
| Target | Ocular surface (cornea and conjunctiva) |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
Hyaluronic acid is a natural humectant that binds water and forms a protective film over the cornea and conjunctiva. This mechanism alleviates symptoms of dry eye disease by improving tear film stability, reducing evaporation, and promoting corneal epithelial healing. The formulation is designed for convenient single-dose administration.
Approved indications
- Dry eye disease / Keratoconjunctivitis sicca
Common side effects
- Ocular irritation
- Transient blurred vision
- Eye discomfort
Key clinical trials
- To Evaluate the Efficacy and Safety of HUC3-053 in Patients With Dry Eye Syndrome (PHASE3)
- Confirmatory Study of OPC-12759 Ophthalmic Suspension (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:
- Hyalein Mini Eye Drops CI brief — competitive landscape report
- Hyalein Mini Eye Drops updates RSS · CI watch RSS
- Huons Co., Ltd. portfolio CI
Frequently asked questions about Hyalein Mini Eye Drops
What is Hyalein Mini Eye Drops?
How does Hyalein Mini Eye Drops work?
What is Hyalein Mini Eye Drops used for?
Who makes Hyalein Mini Eye Drops?
Is Hyalein Mini Eye Drops also known as anything else?
What drug class is Hyalein Mini Eye Drops in?
What development phase is Hyalein Mini Eye Drops in?
What are the side effects of Hyalein Mini Eye Drops?
What does Hyalein Mini Eye Drops target?
Related
- Drug class: All Artificial tear / Lubricating eye drop drugs
- Target: All drugs targeting Ocular surface (cornea and conjunctiva)
- Manufacturer: Huons Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Dry eye disease / Keratoconjunctivitis sicca
- Also known as: Hyalein Mini 0.3%
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing