Bausch + Lomb and Novaliq released the first DED eyedrop that targets tear evaporation.

Medications for dry eye disease (DED) have explored various treatment targets and routes of administration. Current prescriptions exist specifically to address reduction of ocular surface inflammation, while other drugs target tear production. Yet there have not been any modalities aimed at improving abnormal evaporation of tears.

That has now changed, however, particularly for the approximate 86% of DED patients who live with tear evaporation as their main trigger.^1,2 In May 2023, Bausch + Lomb announced FDA approval for MIEBO (perfluorohexyloctane ophthalmic solution), the first and only prescription eyedrop that directly targets tear evaporation. The product is now available at most pharmacies nationwide.

“From a clinical standpoint, this medication could transform the way we take care of people who have dry eye pain,” says Darrell E. White, MD, founder of Skyvision Centers in Westlake, Ohio.

NEW APPROACH TO DED TREATMENT

Designed to reduce tear evaporation at the ocular surface,^3,4 MIEBO is a water-free, preservative-free solution that coats the surface of the eye to prevent tear evaporation — a leading cause of DED due to an altered tear lipid layer that is also often associated with the clinical signs of meibomian gland dysfunction (MGD). An unstable tear film triggers increased ocular surface desiccation, inflammation and damage to the ocular surface,^5,6 but studies show MIEBO helps to decrease the stressors on the surface of the eye.

“To date, all therapies have focused on targeting inflammation or tear production,” says Preeya K. Gupta, MD, a cornea and cataract surgeon at Triangle Eye Consultants in Raleigh, N.C. “What’s truly unique about MIEBO is that the molecule itself mimics the key function of the meibum — which is to reduce tear evaporation by stabilizing the aqueous layer.”

By working on the key functions of the meibum, MIEBO can target DED and the contributors to the breakdown of tear film earlier in the cycle and perhaps before an excessive amount of inflammation sets in, Dr. Gupta says. “Once there’s inflammation on the surface, that’s more of a downstream product of chronic dry eye. Until we have a cure for MGD, patients with evaporative dry eye are going to need something to supplement their lack of good quality meibum.”

As Dr. White explains, evaporation off the surface of the eye is accelerated with MGD because the lipid that’s produced in the meibomian glands isn’t working well enough. “You get the same inflammation that you have in all other types of dryness, but we have been missing something that is directly focused on the evaporative dry eye,” he says. “Enter MIEBO.”

TREATMENT TRIALS AND TACTICS

The approval comes on the heels of two Phase 3, 57-day, multicenter, randomized, double-masked, saline-controlled studies that enrolled more than 1,200 patients with a history of DED and clinical signs of MGD.^7,8 MIEBO reportedly met two primary sign and symptom efficacy endpoints during the trials: change from baseline at Week 8 in total corneal fluorescein staining (tCFS) and eye dryness Visual Analog Scale (VAS) score.

Patients experienced relief of symptoms as early as Day 15 and through Day 57 with statistically significant reduction in VAS favoring MIEBO observed in both studies. At Days 15 and 57, a significant reduction in tCFS favoring MIEBO was observed in both studies.

Administered in 15 microliters, approximately one-fifth the size of typical drops, MIEBO doesn’t have any significant side effects, according to Drs. Gupta and White. The most common adverse effect seen in studies was blurred vision (1% to 3% of patients reported blurred vision and conjunctival redness) and eye redness (1% to 3% of patients). Patients should be instructed to remove contact lenses before using the medication and wait at least 30 minutes before reinsertion.

“It’s a small drop, so patients should be careful to ensure the drop has been placed in the eye. But there’s no clinical harm if extra drops are placed on the eye mistakenly,” says Dr. White.

PATIENT PROSPECTUS

Both Dr. Gupta and Dr. White expect a varied patient profile for MIEBO. “Anyone with DED will be appropriate,” says Dr. Gupta. “It’s been well-studied in patients with both dry eye and MGD. That said, this medication could have broader applicability.”

According to Dr. White, “The classic patient is going to be one who might not have a lot of corneal staining who probably doesn’t have an elevated tear osmolarity, with or without asymmetry between the two eyes.

“It’s also going to work well in patients with a mixed-mechanism dry eye where there’s been a great job treating inflammation on the ocular surface and a great job treating aqueous deficiency, but the patient still has evaporation and symptoms,” he adds. “You’re not going to stop your core treatment, but you’re certainly going to be justified in layering MIEBO on because your patients are uncomfortable.”

It’s also likely that MIEBO will work well among patients on an acute or chronic basis and in collaboration with other medications or as a standalone. “MIEBO isn’t like anything else,” says Dr. White. “It’s going to play well in everybody’s sandbox.” OM.

REFERENCES

1. Findlay Q, Reid K. Dry eye disease: when to treat and when to refer. Australian Prescriber. 2018; 41:160-163.
2. Lemp MA, Crews LA, Bron AJ. Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea. 2012;31:472-478.
3. Sheppard JD, Nichols KK. Dry eye disease associated with meibomian gland dysfunction: focus on tear film characteristics and the therapeutic landscape. Ophthalmol Ther. 2023; 12:1397-1418.
4. Borchman D, Vittitow J, Ewurum A, Veligandl SR. Spectroscopic study of perfluorohexyloctane human meibum interactions. Invest Ophthalmol Vis Sci. 2022;63:1525.
5. Craig JP, Nelson JD, Azar DT, Belmonte C, Bron AJ, Chauhan SK. TFOS DEWS II report executive summary. Ocul Surf. 2017;15:802-812.
6. Pflugfelder SC, Paiva CS. The pathophysiology of dry eye disease: what we know and future directions for research. Ophthalmology. 2017;124(Suppl 11):S4-13.
7. Tauber J, Berdy GJ, Wirta DL, Krösser S, Vittitow JL, GOBI Study Group. NOV03 for dry eye disease associated with meibomian gland dysfunction: results of the randomized phase 3 GOBI study. Ophthalmology. 2023;130:516-524.
8. Sheppard JD, Kurata F, Epitropoulos AT, Krösser S, Vittitow JL; MOJAVE Study Group. NOV03 for signs and symptoms of dry eye disease associated with meibomian gland dysfunction: the randomized phase 3 Mojave study. Am J Ophthalmol. 2023; 252:265-274.