FDA Approves Perfluorohexyloctane Ophthalmic Solution for Dry Eye Disease

Perfluorohexyloctane ophthalmic solution (Miebo; Bausch + Lomb) has been approved by the FDA for the treatment signs and symptoms of dry eye disease, marking the first and only FDA-approved treatment for dry eye disease that directly targets tear evaporation.

Dry eye disease affects millions of Americans and is one of the most common disorders of the ocular surface. A leading cause of the disease is excessive tear evaporation, caused by an altered tear lipid layer. This excessive evaporation is often associated with the clinical signs of Meibomian gland dysfunction and can trigger increased ocular surface desiccation, inflammation, and damage to the ocular surface.

“Tear evaporation, which is a leading driver of [dry eye disease], presents a significant treatment challenge,” said Paul Karpecki, OD, director of Cornea and External Disease at the Kentucky Eye Institute, in a press release. “With the approval of Miebo, eye care professionals can now take a new approach to dry eye disease therapy with a first-in-class water- and preservative-free prescription treatment option that specifically addresses tear evaporation.”

Perfluorohexyloctane ophthalmic solution is designed specifically to reduce tear evaporation at the ocular surface. More than 1200 patients with a history of dry eye disease and clinical signs of Meibomian gland dysfunction were enrolled in the GOBI and MOJAVE phase 3 pivotal trials.

Treatment with Miebo met both primary sign and symptom efficacy endpoints in both trials. The 2 primary endpoints were change from baseline at week 8 in total corneal fluorescein staining and eye dryness Visual Analog Scale (VAS) score. Patients experienced relief of symptoms as early as day 15 and through day 57 with a statistically significant reduction in VAS eye dryness score favoring Miebo observed in both studies. Additionally, at days 15 and 57, a significant reduction in total corneal fluorescein staining favoring Miebo was observed in both studies.

“In the 2 pivotal clinical trials, Miebo addressed the persistent and chronic nature of dry eye disease by providing sustained improvement in both the signs and symptoms of dry eye disease,” said Preeya Gupta, MD, a cornea and cataract surgeon with Triangle Eye Consultants in Raleigh, North Carolina, in the press release. “Because Miebo inhibits evaporation, it may be an appropriate treatment option for patients whose tear evaporation exceeds tear supply.”

The most common adverse reactions among participants receiving Miebo were blurred vision (1.3%–3%) and eye redness (1%–3%). Patients should remove contact lenses before using Miebo and wait at least 30 minutes before reinserting. It is not known whether Miebo is safe and effective for use in children under the age of 18.

“Today’s FDA approval of Miebo further advances dry eye disease treatment by addressing a significant unmet need for millions of people suffering with this disease,” said Brent Saunders, chairman and CEO of Bausch + Lomb, in the press release. “We are proud to bring to market the first and only prescription eye drop approved in the United States for the treatment of [dry eye disease] that directly targets evaporation. We expect to make Miebo commercially available in the second half of this year.”

REFERENCE

Bausch + Lomb and Novaliq Announce FDA Approval of Miebo (Perfluorohexyloctane Ophthalmic Solution) for the Treatment of the Signs and Symptoms of Dry Eye Disease. News release. Bausch + Lomb. May 18, 2023. Accessed May 19, 2023. https://www.bausch.com/news/releases/?id=156