US FDA Approved Omidenepeg Isopropyl Eye Drops for Reduction of Elevated IOP


The US Food and Drug Administration (FDA) has approved omidenepag isopropyl ophthalmic solution (OMLONTI) 0.002% eye drops for treating the elevated intraocular pressure (IOP) in patients with primary glaucoma.

OMLONTI 0.002%, is a selective prostaglandin E2 receptor agonist that is indicated for the reduction of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma.

OMLONTI is produced jointly by UBE and Santen. Omidenepag isopropyl, which is the active pharmaceutical ingredient in OMLONTI, was developed by UBE, and it is a relatively selective prostaglandin EP2 receptor agonist that increases aqueous humor drainage through the conventional pathway.

OMLONTI was launched in Japan in November 2018, and has filed for marketing approval in several Asian countries in various stages. The product was also released in five regions and countries starting in February 2021.

Glaucoma causes damage to the optic nerve that results in visual field loss, and it remains a leading cause of irreversible blindness worldwide. Since the disease is progressive, early detection and treatment to control the progression are very crucial, and decreasing IOP is the most effective means of avoiding damage to the optic nerve.

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Peter Sallstig, chief medical officer of Santen, said that the prevalence of Glaucoma is increasing as the population ages globally. This approval is an important step in their ambition to tackle unmet needs in eye health and advances their goal of happiness with vision.