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Perfluorohexyloctane – Active Ingredient for Dry Eye

Perfluorohexyloctane (F6H8) is a synthetic active ingredient used to treat dry eye disease. It stabilises the tear film and relieves ocular discomfort.

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Things worth knowing about "Perfluorohexyloctane"

Perfluorohexyloctane (F6H8) is a synthetic active ingredient used to treat dry eye disease. It stabilises the tear film and relieves ocular discomfort.

What is Perfluorohexyloctane?

Perfluorohexyloctane, commonly abbreviated as F6H8, is a semifluorinated alkane used in the treatment of dry eye disease (keratoconjunctivitis sicca). It is a clear, water-free liquid formulated as eye drops. The compound is marketed under trade names such as NOV03 and has been specifically developed for patients suffering from dry eye associated with Meibomian Gland Dysfunction (MGD).

Mechanism of Action

Perfluorohexyloctane acts on the ocular surface by stabilising and supplementing the lipid layer of the tear film. The tear film consists of three layers: a mucin layer, an aqueous layer, and a lipid layer. In Meibomian Gland Dysfunction, the lipid layer is reduced or altered, leading to rapid evaporation of the tear fluid.

Perfluorohexyloctane spreads evenly across the ocular surface and forms a protective film.
It reduces the evaporation rate of the tear fluid.
As a water-free formulation, it contains no preservatives such as benzalkonium chloride, which can irritate ocular tissue.
By stabilising the tear film, it helps reduce inflammatory responses on the ocular surface.

Indications

Perfluorohexyloctane is indicated for adults with dry eye disease associated with Meibomian Gland Dysfunction. MGD affects the oil-secreting glands along the eyelid margins and is one of the most common causes of evaporative dry eye.

Dosage and Administration

The recommended dose of perfluorohexyloctane is typically one drop four times daily in the affected eye(s). Application should always follow the prescribing physician's instructions and the package leaflet. Key administration notes include:

The formulation is preservative-free and therefore suitable for sensitive eyes.
Contact lenses should be removed before application and reinserted no earlier than 15 minutes afterwards.
If other eye drops are used concurrently, a minimum interval of 5 minutes between applications is recommended.

Side Effects

Perfluorohexyloctane is generally well tolerated. Possible side effects include:

Transient blurred vision immediately after application
Mild burning or stinging upon instillation
Hypersensitivity reactions (rare)

No serious adverse effects have been reported to date. If persistent or unusual symptoms occur, medical advice should be sought.

Clinical Evidence

The efficacy and safety of perfluorohexyloctane have been demonstrated in clinical trials. In the pivotal Phase 3 study, the active ingredient showed significant improvements in dry eye symptoms as well as objective parameters such as tear film stability and corneal fluorescein staining. Based on these data, the European Medicines Agency (EMA) granted marketing authorisation for the product.

References

European Medicines Agency (EMA): Assessment Report on Perfluorohexyloctane Eye Drops. EMA/CHMP, 2023.
Tauber J. et al. - Randomized Phase 3 Study of Perfluorohexyloctane Ophthalmic Solution for Dry Eye Disease Associated with Meibomian Gland Dysfunction. Ophthalmology, 2023.
Craig J.P. et al. - TFOS DEWS II Report Executive Summary. The Ocular Surface, 2017.

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