Last reviewed 2026-05-20 · How we verify

Hyalein Mini Ophthalmic solution

Otsuka Pharmaceutical Co., Ltd. · Phase 3 active Small molecule ✓ Verified May 2026

Hyalein Mini Ophthalmic solution is a Artificial tear / Lubricating ophthalmic agent Small molecule drug developed by Otsuka Pharmaceutical Co., Ltd.. It is currently in Phase 3 development for Dry eye disease, Post-operative ocular surface protection.

Hyalein Mini is a hyaluronic acid-based ophthalmic solution that lubricates and protects the ocular surface.

Hyalein Mini Ophthalmic solution is used to treat Dry Eye Syndromes. It is an oligosaccharide modality, specifically an oligosaccharide with anticoagulant properties similar to heparin.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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 Ophthalmic solution
Sponsor	Otsuka Pharmaceutical Co., Ltd.
Drug class	Artificial tear / Lubricating ophthalmic agent
Target	Ocular surface (non-receptor mediated)
Modality	Small molecule
Therapeutic area	Ophthalmology
Phase	Phase 3

Mechanism of action

Hyaluronic acid is a naturally occurring polysaccharide that acts as a viscoelastic lubricant, reducing friction and providing moisture to the cornea and conjunctiva. It forms a protective film on the eye surface, promoting epithelial healing and reducing irritation associated with dry eye disease and post-operative ocular surface damage.

Approved indications

Dry eye disease
Post-operative ocular surface protection

Common side effects

Ocular irritation
Blurred vision
Eye discomfort

Key clinical trials

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 Ophthalmic solution CI brief — competitive landscape report
Hyalein Mini Ophthalmic solution updates RSS · CI watch RSS
Otsuka Pharmaceutical Co., Ltd. portfolio CI

Frequently asked questions about Hyalein Mini Ophthalmic solution

What is Hyalein Mini Ophthalmic solution?

Hyalein Mini Ophthalmic solution is a Artificial tear / Lubricating ophthalmic agent drug developed by Otsuka Pharmaceutical Co., Ltd., indicated for Dry eye disease, Post-operative ocular surface protection.

How does Hyalein Mini Ophthalmic solution work?

Hyalein Mini is a hyaluronic acid-based ophthalmic solution that lubricates and protects the ocular surface.

What is Hyalein Mini Ophthalmic solution used for?

Hyalein Mini Ophthalmic solution is indicated for Dry eye disease, Post-operative ocular surface protection.

Who makes Hyalein Mini Ophthalmic solution?

Hyalein Mini Ophthalmic solution is developed by Otsuka Pharmaceutical Co., Ltd. (see full Otsuka Pharmaceutical Co., Ltd. pipeline at /company/otsuka).

What drug class is Hyalein Mini Ophthalmic solution in?

Hyalein Mini Ophthalmic solution belongs to the Artificial tear / Lubricating ophthalmic agent class. See all Artificial tear / Lubricating ophthalmic agent drugs at /class/artificial-tear-lubricating-ophthalmic-agent.

What development phase is Hyalein Mini Ophthalmic solution in?

Hyalein Mini Ophthalmic solution is in Phase 3.

What are the side effects of Hyalein Mini Ophthalmic solution?

Common side effects of Hyalein Mini Ophthalmic solution include Ocular irritation, Blurred vision, Eye discomfort.

What does Hyalein Mini Ophthalmic solution target?

Hyalein Mini Ophthalmic solution targets Ocular surface (non-receptor mediated) and is a Artificial tear / Lubricating ophthalmic agent.

Drug class: All Artificial tear / Lubricating ophthalmic agent drugs
Target: All drugs targeting Ocular surface (non-receptor mediated)
Manufacturer: Otsuka Pharmaceutical Co., Ltd. — full pipeline
Therapeutic area: All drugs in Ophthalmology
Indication: Drugs for Dry eye disease
Indication: Drugs for Post-operative ocular surface protection

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing