Last reviewed 2026-05-21 · How we verify

DE-114 ophthalmic solution

Santen Pharmaceutical Co., Ltd. · Phase 3 active Small molecule Under review

DE-114 ophthalmic solution is a Rho kinase inhibitor Small molecule drug developed by Santen Pharmaceutical Co., Ltd.. It is currently in Phase 3 development for Glaucoma or ocular hypertension. Also known as: Epinastine ophthalmic solution.

DE-114 is a selective rho kinase inhibitor that reduces intraocular pressure by increasing uveoscleral outflow of aqueous humor.

DE-114 ophthalmic solution is an oligosaccharide modality used to treat allergic conjunctivitis. It is being studied in a long-term open-label phase 3 clinical trial for its efficacy in patients with allergic conjunctivitis.

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	DE-114 ophthalmic solution
Also known as	Epinastine ophthalmic solution
Sponsor	Santen Pharmaceutical Co., Ltd.
Drug class	Rho kinase inhibitor
Target	ROCK (Rho-associated coiled-coil containing protein kinase)
Modality	Small molecule
Therapeutic area	Ophthalmology
Phase	Phase 3

Mechanism of action

DE-114 inhibits Rho-associated coiled-coil containing protein kinase (ROCK), which plays a key role in regulating the cytoskeleton and cell contractility in the eye. By blocking ROCK signaling, the drug enhances drainage of aqueous humor through the uveoscleral pathway, thereby lowering intraocular pressure. This mechanism is distinct from prostaglandin analogs and other conventional glaucoma therapies.

Approved indications

Glaucoma or ocular hypertension

Common side effects

Conjunctival hyperemia
Eye irritation
Instillation site 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:

DE-114 ophthalmic solution CI brief — competitive landscape report
DE-114 ophthalmic solution updates RSS · CI watch RSS
Santen Pharmaceutical Co., Ltd. portfolio CI

Frequently asked questions about DE-114 ophthalmic solution

What is DE-114 ophthalmic solution?

DE-114 ophthalmic solution is a Rho kinase inhibitor drug developed by Santen Pharmaceutical Co., Ltd., indicated for Glaucoma or ocular hypertension.

How does DE-114 ophthalmic solution work?

DE-114 is a selective rho kinase inhibitor that reduces intraocular pressure by increasing uveoscleral outflow of aqueous humor.

What is DE-114 ophthalmic solution used for?

DE-114 ophthalmic solution is indicated for Glaucoma or ocular hypertension.

Who makes DE-114 ophthalmic solution?

DE-114 ophthalmic solution is developed by Santen Pharmaceutical Co., Ltd. (see full Santen Pharmaceutical Co., Ltd. pipeline at /company/santen-pharmaceutical-co-ltd).

Is DE-114 ophthalmic solution also known as anything else?

DE-114 ophthalmic solution is also known as Epinastine ophthalmic solution.

What drug class is DE-114 ophthalmic solution in?

DE-114 ophthalmic solution belongs to the Rho kinase inhibitor class. See all Rho kinase inhibitor drugs at /class/rho-kinase-inhibitor.

What development phase is DE-114 ophthalmic solution in?

DE-114 ophthalmic solution is in Phase 3.

What are the side effects of DE-114 ophthalmic solution?

Common side effects of DE-114 ophthalmic solution include Conjunctival hyperemia, Eye irritation, Instillation site discomfort.

What does DE-114 ophthalmic solution target?

DE-114 ophthalmic solution targets ROCK (Rho-associated coiled-coil containing protein kinase) and is a Rho kinase inhibitor.

Drug class: All Rho kinase inhibitor drugs
Target: All drugs targeting ROCK (Rho-associated coiled-coil containing protein kinase)
Manufacturer: Santen Pharmaceutical Co., Ltd. — full pipeline
Therapeutic area: All drugs in Ophthalmology
Indication: Drugs for Glaucoma or ocular hypertension
Also known as: Epinastine ophthalmic solution

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