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Artificial Tears Methylcellulose
Artificial Tears Methylcellulose is a Artificial tear / Lubricating agent Small molecule drug developed by Vanderbilt University Medical Center. It is currently in Phase 3 development for Dry eye disease / Keratoconjunctivitis sicca.
Methylcellulose forms a protective lubricating film on the ocular surface to relieve dry eye symptoms.
Artificial tears containing methylcellulose are used to treat conditions such as Allergic Conjunctivitis and Primary Open Angle Glaucoma, as indicated by ClinicalTrials.gov. Methylcellulose is a bulk-forming laxative, according to ChEMBL, but its exact mechanism in artificial tears is unknown.
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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 | Artificial Tears Methylcellulose |
|---|---|
| Sponsor | Vanderbilt University Medical Center |
| Drug class | Artificial tear / Lubricating agent |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
Methylcellulose is a cellulose-based polymer that increases tear film viscosity and provides prolonged ocular surface hydration. It acts as an artificial tear substitute, coating the cornea and conjunctiva to reduce friction, protect epithelial cells, and maintain moisture on the eye surface. This mechanism provides symptomatic relief in dry eye disease by mimicking natural tear properties.
Approved indications
- Dry eye disease / Keratoconjunctivitis sicca
Common side effects
- Blurred vision
- Eye irritation
- Ocular discomfort
Key clinical trials
- Feasibility, Clinical Effects, and Safety of Psilocybin-assisted Psychotherapy for Treatment-resistant OCD (PHASE1)
- Synbiotic Supplement With Botanical Extracts for Gut Microbiota Balance in Irritable Bowel Syndrome (NA)
- Effect of Daily Humiome® Post LB Intake on Wellbeing in Older Individuals With Moderate Stress Levels (NA)
- Effectiveness of Topical Magnetite Zinc Oxide Composite Nanoparticles in the Management of Oral Potentially Malignant Lesions (EARLY_PHASE1)
- Evaluation of Manzanilla® and Meticel Ofteno® 0.5% for Providing a Relief Sensation to the Eyes (PHASE4)
- Sublingual Atropine Bioequivalence by Route of Administration (SABER) (PHASE1)
- Effect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour (PHASE3)
- Effects of a Standardised Saffron Extract Supplementation on Symptoms Associated With Perimenopause in Healthy Women (NA)
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:
- Artificial Tears Methylcellulose CI brief — competitive landscape report
- Artificial Tears Methylcellulose updates RSS · CI watch RSS
- Vanderbilt University Medical Center portfolio CI
Frequently asked questions about Artificial Tears Methylcellulose
What is Artificial Tears Methylcellulose?
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Related
- Drug class: All Artificial tear / Lubricating agent drugs
- Manufacturer: Vanderbilt University Medical Center — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Dry eye disease / Keratoconjunctivitis sicca
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing