MIEBO Perfluorocyclohexane New Eye Drop

MIEBO, Perfluorocyclohexane opthalmic solution drops, was recently FDA-approved and my first patient has started the medication. 

Perfluorocyclohexane is a well known, chemically inert, thermally stable substance that reminded me of thick wax when we used this in the lab as an undergrad at Columbia. 

It is a non-toxic, clear, waxy solid, at certain temperatures and it 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 years 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 their 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. 

Waiting to see out how our first patient 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.

MIEBO is indicated for the treatment of the signs and symptoms of dry eye disease (DED)

MIEBO is the first & only Rx eye drop for DED that directly targets evaporation1

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.