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Systane Ultra Multidose
Systane Ultra Multidose is a eye lubricant Small molecule drug developed by Allergan. It is currently in Phase 3 development for Relief of dryness and irritation associated with dry eye syndrome.
Systane Ultra Multidose lubricates the eyes to help relieve dryness and irritation.
Systane Ultra Multidose is a small molecule artificial tear formulation used to treat Dry Eye Disease and Dry Eye Syndrome. It is compared to other artificial tear formulations in clinical trials, such as REFRESH PLUS, for its efficacy and safety.
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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 | Systane Ultra Multidose |
|---|---|
| Sponsor | Allergan |
| Drug class | eye lubricant |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
It does this by creating a protective barrier on the surface of the eye, helping to retain moisture and reduce friction between the eyelid and cornea. This can help to alleviate symptoms of dry eye syndrome, such as grittiness, burning, and blurred vision.
Approved indications
- Relief of dryness and irritation associated with dry eye syndrome
Common side effects
- Eye irritation
Key clinical trials
- Efficacy and Safety of a New Artificial Tear Formulation Compared With Systane Ultra Multidose in Participants With Dry Eye Disease (PHASE3)
- Efficacy and Safety of the Ophthalmic Solution PRO-087 Versus Systane ® Ultra and Ultra Preservative Free (087LATAMFIV) (PHASE4)
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:
- Systane Ultra Multidose CI brief — competitive landscape report
- Systane Ultra Multidose updates RSS · CI watch RSS
- Allergan portfolio CI
Frequently asked questions about Systane Ultra Multidose
What is Systane Ultra Multidose?
How does Systane Ultra Multidose work?
What is Systane Ultra Multidose used for?
Who makes Systane Ultra Multidose?
What drug class is Systane Ultra Multidose in?
What development phase is Systane Ultra Multidose in?
What are the side effects of Systane Ultra Multidose?
Related
- Drug class: All eye lubricant drugs
- Manufacturer: Allergan — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Relief of dryness and irritation associated with dry eye syndrome
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing