Last reviewed 2026-05-31 · How we verify

DE-127 Ophthalmic Solution high dose

Santen Pharmaceutical Co., Ltd. · Phase 2 active Small molecule ✓ Verified May 2026 Quality 10/100

DE-127 Ophthalmic Solution high dose is a Small molecule drug developed by Santen Pharmaceutical Co., Ltd.. It is currently in Phase 2 development.

DE-127 Ophthalmic Solution is being studied for its efficacy and safety in treating mild or moderate myopia. According to ClinicalTrials.gov, DE-127 Ophthalmic Solution is being tested in various doses, including high dose, for this condition.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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-127 Ophthalmic Solution high dose
Sponsor	Santen Pharmaceutical Co., Ltd.
Modality	Small molecule
Phase	Phase 2

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

A Study Assessing the Efficacy and Safety of DE-127 Ophthalmic Solution in Subjects With Mild or Moderate Myopia (APPLE) (PHASE2)

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-127 Ophthalmic Solution high dose CI brief — competitive landscape report
DE-127 Ophthalmic Solution high dose updates RSS · CI watch RSS
Santen Pharmaceutical Co., Ltd. portfolio CI

Frequently asked questions about DE-127 Ophthalmic Solution high dose

What is DE-127 Ophthalmic Solution high dose?

DE-127 Ophthalmic Solution high dose is a Small molecule drug developed by Santen Pharmaceutical Co., Ltd..

Who makes DE-127 Ophthalmic Solution high dose?

DE-127 Ophthalmic Solution high dose is developed by Santen Pharmaceutical Co., Ltd. (see full Santen Pharmaceutical Co., Ltd. pipeline at /company/santen-pharmaceutical-co-ltd).

What development phase is DE-127 Ophthalmic Solution high dose in?

DE-127 Ophthalmic Solution high dose is in Phase 2.

Manufacturer: Santen Pharmaceutical Co., Ltd. — full pipeline

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