Last reviewed · How we verify
DE-117 Ophthalmic Solution BID
DE-117 Ophthalmic Solution BID is a anti-inflammatory Small molecule drug developed by Santen Inc.. It is currently in Phase 2 development for Treatment of non-infectious uveitis affecting the posterior segment of the eye.
DE-117 Ophthalmic Solution BID is an anti-inflammatory agent.
DE-117 Ophthalmic Solution is used to treat Glaucoma and Ocular Hypertension, as well as Primary Open-angle Glaucoma and Ocular Hypertension. It is an oligosaccharide-based solution, with its exact mechanism of action not specified in the provided information.
-
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).
| 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-117 Ophthalmic Solution BID |
|---|---|
| Sponsor | Santen Inc. |
| Drug class | anti-inflammatory |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 2 |
Mechanism of action
DE-117 Ophthalmic Solution BID works by reducing inflammation in the eye, which can help to treat conditions such as uveitis and other inflammatory eye diseases.
Approved indications
- Treatment of non-infectious uveitis affecting the posterior segment of the eye
Common side effects
- Eye irritation
Key clinical trials
- A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 3 Study (PHASE3)
- A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study (PHASE3)
- Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma SPECTRUM 6 (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-117 Ophthalmic Solution BID CI brief — competitive landscape report
- DE-117 Ophthalmic Solution BID updates RSS · CI watch RSS
- Santen Inc. portfolio CI
Frequently asked questions about DE-117 Ophthalmic Solution BID
What is DE-117 Ophthalmic Solution BID?
How does DE-117 Ophthalmic Solution BID work?
What is DE-117 Ophthalmic Solution BID used for?
Who makes DE-117 Ophthalmic Solution BID?
What drug class is DE-117 Ophthalmic Solution BID in?
What development phase is DE-117 Ophthalmic Solution BID in?
What are the side effects of DE-117 Ophthalmic Solution BID?
Related
- Drug class: All anti-inflammatory drugs
- Manufacturer: Santen Inc. — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Treatment of non-infectious uveitis affecting the posterior segment of the eye
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing