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Tavilermide ophthalmic solution
Tavilermide ophthalmic solution is a Integrin antagonist Small molecule drug developed by Mimetogen Pharmaceuticals USA, Inc.. It is currently in Phase 3 development for Dry eye disease, Ocular inflammation.
Tavilermide is a small-molecule integrin antagonist that inhibits cell adhesion and migration by blocking integrin-mediated interactions, reducing inflammatory cell infiltration in ocular tissues.
Tavilermide ophthalmic solution is a protein-based medication used to treat dry eye conditions, including Dry Eye Syndromes, Keratoconjunctivitis Sicca, and Dry Eye Disease. It is administered as an ophthalmic solution, typically in a 1% concentration, and has been studied in clinical trials for its safety and efficacy in treating these conditions.
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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 | Tavilermide ophthalmic solution |
|---|---|
| Sponsor | Mimetogen Pharmaceuticals USA, Inc. |
| Drug class | Integrin antagonist |
| Target | Integrins (α4β1, αLβ2, and other integrin subtypes) |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
Tavilermide works by antagonizing integrins, cell surface receptors that mediate adhesion between cells and the extracellular matrix. By blocking integrin function, the drug reduces the recruitment and infiltration of inflammatory cells into the eye, thereby decreasing ocular inflammation and associated tissue damage. This mechanism is particularly relevant for dry eye disease and other inflammatory ocular conditions where leukocyte infiltration plays a pathogenic role.
Approved indications
- Dry eye disease
- Ocular inflammation
Common side effects
- Ocular irritation
- Conjunctival hyperemia
- Eye discomfort
Key clinical trials
- Efficacy and Safety Evaluation of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye (PHASE3)
- Tavilermide Ophthalmic Solution for the Treatment of Dry Eye (PHASE3)
- A Safety and Efficacy Study of MIM-D3 Ophthalmic Solution for the Treatment of Dry Eye (PHASE3)
- A Safety and Efficacy Study of Tavilermide (MIM-D3) Ophthalmic Solution for the Treatment of Dry Eye Disease (PHASE3)
- A Safety and Efficacy Study of Tavilermide (MIM-D3) Ophthalmic Solution for the Treatment of Dry Eye (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:
- Tavilermide ophthalmic solution CI brief — competitive landscape report
- Tavilermide ophthalmic solution updates RSS · CI watch RSS
- Mimetogen Pharmaceuticals USA, Inc. portfolio CI
Frequently asked questions about Tavilermide ophthalmic solution
What is Tavilermide ophthalmic solution?
How does Tavilermide ophthalmic solution work?
What is Tavilermide ophthalmic solution used for?
Who makes Tavilermide ophthalmic solution?
What drug class is Tavilermide ophthalmic solution in?
What development phase is Tavilermide ophthalmic solution in?
What are the side effects of Tavilermide ophthalmic solution?
What does Tavilermide ophthalmic solution target?
Related
- Drug class: All Integrin antagonist drugs
- Target: All drugs targeting Integrins (α4β1, αLβ2, and other integrin subtypes)
- Manufacturer: Mimetogen Pharmaceuticals USA, Inc. — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Dry eye disease
- Indication: Drugs for Ocular inflammation
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing