FDA Approves New Treatment for Common Symptom of Dry Eye Disease

The US Food and Drug Administration (FDA) has approved a drug to target the excessive tear evaporation associated with dry eye disease.

The treatment, MIEBO (perfluorohexyloctane ophthalmic solution, formerly known as NOV03), is a semifluorinated alkane that works to reduce tear evaporation by forming a monolayer on the tear film.

MIEBO is the only FDA-approved treatment specifically targeting excessive tear evaporation, which affects 86% of people with dry eye disease, according to Bausch + Lomb, which developed the drug with its German partner, Novaliq GmbH.

Excessive evaporation of tears damages the ocular surface over time through inflammation and increased surface desiccation. The development and progression of dry eye disease often are associated with meibomian gland dysfunction, a condition that affects the oil glands on the eyelid. The glands produce oil that prevents the eye's water layer from evaporating too rapidly; when the glands are impaired, evaporation of tears increases.

More than 16 million people in the United States have been diagnosed with dry eye disease, according to a 2017 study. However, the true prevalence could be much higher. The disease is more common among women than men.

The approval is based on two randomized clinical trials in which patients received MIEBO four times daily for 2 months. The trials enrolled a total of more than 1200 patients who had a history of dry eye disease and signs of meibomian gland dysfunction. Participants were randomly administered MIEBO or a placebo solution of hypotonic saline 0.6%.

Patients who received MIEBO experienced statistically significant reductions in eye dryness and on total corneal fluorescein staining. Statistically significant results were observed during the trial at day 15 and at its completion, at day 57, according to Bausch + Lomb. In the trials, the most common side effects with MIEBO were blurred vision and eye redness; both affected up to 3% of the participants.

"We believe that MIEBO will address a significant unmet need for the many Americans who struggle with evaporative dry eye," said Novaliq CEO Christian Roesky, PhD, in a statement from Bausch + Lomb.

The solution is waterless ― a major point of difference in comparison with other eyedrops, which generally use water as a solvent, according to Esen K. Akpek, MD, professor of ophthalmology at the Wilmer Eye Institute at Johns Hopkins University, in Baltimore.

"I think it's revolutionary," she told Medscape Medical News. Akpek said she typically gives her patients ointments for the disease, but the effects do not last long, and her patients complain of burning and stinging.

"I'm hoping it will be able to help our patients," she said.

In 2019, Bausch + Lomb obtained an exclusive license for the commercialization and development of the drug in the United States and Canada. The drug is expected to be commercially available in the second half of this year, according to the company.

Apkek was not involved in the development of MIEBO but has previously worked with Novaliq GmbH.

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Cite this: FDA Approves New Treatment for Common Symptom of Dry Eye Disease - Medscape - May 22, 2023.