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Miebo (PERFLUOROHEXYLOCTANE)
Miebo works by mimicking the natural oils in the eyes to help maintain moisture.
Perflurohexyloctane (Miebo), marketed by Bausch Health, is a novel treatment for Dry Eye Disease that mimics natural eye oils to maintain moisture. Its key strength lies in its unique mechanism of action, which differentiates it from traditional treatments and positions it as a valuable option in the dry eye market. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | PERFLUOROHEXYLOCTANE |
|---|---|
| Sponsor | Bausch Health |
| Drug class | Semifluorinated Alkane [EPC] |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | FDA-approved |
| First approval | 2023 |
Mechanism of action
Perfluorohexyloctane, semifluorinated alkane, contains perfluorinated carbon atoms and hydrogenated carbon atoms. Perfluorohexyloctane forms monolayer at the air-liquid interface of the tear film which can be expected to reduce evaporation. The exact mechanism of action for MIEBO in DED is not known.
Approved indications
- Dry Eye Disease
Common side effects
- blurred vision
Key clinical trials
- SYSTANE® PRO vs. MIEBO™ in Dry Eye Disease (PHASE4)
- A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease (PHASE2)
- A Study to Evaluate the Safety and Effectiveness of Perfluorohexyloctane Eye Drops on Treatment of Dry Eye Disease (DED) Related to Meibomian Gland Dysfunction (MGD)
- A Study to Evaluate Concomitant Perfluorohexyloctane Use With Contact Lens Wear (PHASE4)
- A Study to Assess the Long-Term Safety of Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination in Subjects With Dry Eye Disease (PHASE3)
- A Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease (PHASE4)
- Effects of NOV03 on the Tear Film (PHASE4)
- A Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/Keratometry and Postoperative Refractive Accuracy (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Miebo CI brief — competitive landscape report
- Miebo updates RSS · CI watch RSS
- Bausch Health portfolio CI