Eyecare giant Bausch + Lomb received its first prescription drug approval from the US Food and Drug Administration (FDA) for its dry eye disease med Miebo (perfluorohexyloctane ophthalmic solution).
The eye drops are the first and only FDA-approved treatment that directly target tear evaporation at the ocular surface to treat the signs and symptoms of dry eye disease.
The drug addresses a significant unmet need for patients, said Bausch + Lomb CEO Brent Saunders in a press release.
Dry eye disease is among the most common ocular surface disorders, affecting millions of people in the US. Abnormally high levels of tear evaporation are a leading cause of dry eye disease, which is often associated with the clinical signs of Meibomian gland dysfunction (MGD). The disorder is caused by alterations in the tear lipid layer, namely abnormalities in the oil glands along the lash line. An unstable tear film triggers increased dryness, inflammation and damage to the ocular surface.
Symptoms of dry eye disease include burning, dry or itchy eyes, blurred vision, sensitivity to light and eye redness. The condition is diagnosed based on the amount and quality of tears through a dilated eye exam. Reduced tear production is another cause of the disease.
The most common dry eye disease treatments are over-the-counter (OTC) eye drops like ‘artificial tears’ for mild disease.
Designed to help the eyes make more tears, AbbVie’s Restasis (cyclosporine) and Novartis’ Xiidra (lifitegrast) are prescription dry eye treatments for more severe cases. Last year, the FDA approved the first generic version of Restasis.
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“Today’s FDA approval of Miebo further advances DED [dry eye disease] treatment by addressing a significant unmet need for millions of people suffering with this disease,” said Saunders. “We are proud to bring to market the first and only prescription eye drop approved in the United States for the treatment of DED that directly targets evaporation. We expect to make Miebo commercially available in the second half of this year.”
Miebo’s FDA approval was based on two Phase III clinical trials that involved a total of 1,217 patients with a history of dry eye disease and signs of MGD. Bausch + Lomb reported that in the 57-day studies, patients experienced lasting symptom relief as early as Day 15 and maintained a statistically significant reduction in eye dryness compared with saline placebo.
Bausch + Lomb is set to launch Miebo in the second half of this year, according to Saunders.
In the latter half of 2019, the company secured an exclusive license for Miebo in the US and Canada for an undisclosed amount.
Alderya Therapeutics is looking to enter the dry eye disease space as a competitor with its reproxalap. The drug is currently under FDA review with a decision date set for November. Viatris’ generic version of Restasis could also be a competitor given the lower cost of generics.
The global dry eye disease market was valued at $5.53 billion in 2022 with North America holding the largest market share at 37.6 percent.