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Placebo Ophthalmic Solution
Placebo Ophthalmic Solution is a Small molecule drug developed by ORA, Inc.. It is currently in Phase 3 development for Treatment of dry eye syndrome. Also known as: placebo, Vehicle, artificial tears, Inactive control (vehicle).
This is a placebo ophthalmic solution, meaning it has no active therapeutic effect.
This is a placebo ophthalmic solution, meaning it has no active therapeutic effect. Used for Treatment of dry eye syndrome.
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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 | Placebo Ophthalmic Solution |
|---|---|
| Also known as | placebo, Vehicle, artificial tears, Inactive control (vehicle), Matching placebo |
| Sponsor | ORA, Inc. |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
As a placebo, it is designed to mimic the appearance and feel of a real medication, but without any actual pharmacological activity. This allows researchers to compare the effects of the real treatment to a control group, helping to establish the efficacy of the actual medication.
Approved indications
- Treatment of dry eye syndrome
Common side effects
Key clinical trials
- Phase 3 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant (PHASE3)
- Lacripep for Corneal Wound Healing Study (PHASE2)
- FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial (PHASE3)
- This is a Single Center, Open-label Prospective Study to Evaluate the Effect of Xiidra® (Lifitegrast Ophthalmic Solution 5.0%) on Tear Film Biomarkers in Dry Eye (PHASE4)
- A Study to Evaluate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD) (PHASE3)
- Safety and Efficacy of the PAINLESS Nerve Growth Factor CHF6467 in Optic Pathway Glioma (OPG) (PHASE2)
- Traditional Chinese Medicine Ultrasonic Atomization Treatment for Dry Eye Disease (NA)
- Efficacy of Fusidic Acid 1% in the Treatment of Bacterial Conjunctivitis (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:
- Placebo Ophthalmic Solution CI brief — competitive landscape report
- Placebo Ophthalmic Solution updates RSS · CI watch RSS
- ORA, Inc. portfolio CI
Frequently asked questions about Placebo Ophthalmic Solution
What is Placebo Ophthalmic Solution?
How does Placebo Ophthalmic Solution work?
What is Placebo Ophthalmic Solution used for?
Who makes Placebo Ophthalmic Solution?
Is Placebo Ophthalmic Solution also known as anything else?
What development phase is Placebo Ophthalmic Solution in?
Related
- Manufacturer: ORA, Inc. — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Treatment of dry eye syndrome
- Also known as: placebo, Vehicle, artificial tears, Inactive control (vehicle), Matching placebo
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing