MIEBO, Perfluorocyclohexane opthalmic solution drops, was recently FDA-approved. Perfluorocyclohexane is a well known, chemically inert, thermally stable substance that reminds me of thick wax when I used this in the lab as an undergrad at certain temperatures. It is a relatively non-toxic, clear, waxy solid, which has a high vapor pressure and therefore sublimes (ie it goes from being a solid to a gas readily at room temperature. The company likely had to alter its chemical structure to help it stabilize as a drop at room temperature.
It has been used for year in Europe with good results. Patients have complained of blurriness or redness (1-3% roughly). Otherwise it should help patients.
No studies looking at meibographies before and after its use have been done. It would be nice to confirm that it does not damage meibomian glands, though I can not find a reason it would as it does not have a preservative. Still, hopefully that study will be done as it is unleashed.
Our first patient is starting in July 2023. Waiting to find out how she tolererates it.
SLC
Few more notes:
1. Miebo has strong spreading properties due to low surface tension, facilitating small drop sizes and interacting with the lipophilic (ie fat or meibum) part of the tear film to form a layer at the film–air interface and prevent evaporation.
Semifluorinated Alkane Eye Drops
Perfluorohexyloctane (F6H8, NovaTears) (Novaliq, Heidelberg, Germany), in the family of semifluorinated alkanes, is a novel nonaqueous liquid, nonblurring wetting agent commercialized in Europe (EvoTears by Ursapharm) and Australia and New Zealand (AFT Pharmaceuticals) for the treatment of evaporative dry eye disease. Perfluorohexyloctane demonstrates strong spreading properties due to low surface tension, facilitating small drop sizes and interacting with the lipophilic part of the tear film to form a layer at the film–air interface and prevent evaporation.168 Steven et al. conducted an observational prospective, multicenter 6–8 week study of 61 patients with MGD and DED who received one drop of Perfluorohexyloctane four times daily. The study showed there was a significant reduction in corneal and conjunctival fluorescein staining, increase in number of expressible meibomian glands, increase in tear film break-up time, and improvement in severity of anterior and posterior blepharitis and improvement in OSDI score.169
NOVO3 (100% perfluorohexyloctane), an investigational drug in the United States, completed a Phase II study (SEECASE), a prospective, multicenter, randomized, double-masked, saline-controlled study of 336 DED patients. In the study, patients were randomized in a 2:2:1:1 manner to NOVO3 four times daily, NOVO3 twice daily, saline twice daily, and saline four times daily, respectively. The study met its primary endpoint of improvement in corneal fluorescein staining over control at 8 weeks and also showed significant improvement in symptoms.170 Two Phase 3 studies are currently taking place in the United States for NOVO3.
