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OTX-101 0.09%
OTX-101 0.09% is a ophthalmic solution Small molecule drug developed by Sun Pharmaceutical Industries Limited. It is currently in Phase 3 development for Treatment of dry eye disease. Also known as: Seciera.
OTX-101 is a topical ophthalmic solution used to treat dry eye disease.
OTX-101 is a topical ophthalmic solution used to treat dry eye disease. Used for Treatment of dry eye disease.
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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 | OTX-101 0.09% |
|---|---|
| Also known as | Seciera |
| Sponsor | Sun Pharmaceutical Industries Limited |
| Drug class | ophthalmic solution |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
It works by increasing tear production in the eyes, providing relief from dryness and discomfort. OTX-101 is a novel approach to treating dry eye disease, offering a new option for patients who have not responded to other treatments.
Approved indications
- Treatment of dry eye disease
Common side effects
- Eye irritation
Key clinical trials
- Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca (PHASE3)
- Phase 2/3 Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca (PHASE2, PHASE3)
- An Open-Label Extension of a Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca (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:
- OTX-101 0.09% CI brief — competitive landscape report
- OTX-101 0.09% updates RSS · CI watch RSS
- Sun Pharmaceutical Industries Limited portfolio CI
Frequently asked questions about OTX-101 0.09%
What is OTX-101 0.09%?
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What is OTX-101 0.09% used for?
Who makes OTX-101 0.09%?
Is OTX-101 0.09% also known as anything else?
What drug class is OTX-101 0.09% in?
What development phase is OTX-101 0.09% in?
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Related
- Drug class: All ophthalmic solution drugs
- Manufacturer: Sun Pharmaceutical Industries Limited — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Treatment of dry eye disease
- Also known as: Seciera
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing