Santen Inc. and UBE Corporation (UBE) announced that the U.S. Food and Drug Administration (FDA) has approved OMLONTI (omidenepag isopropyl ophthalmic solution) 0.002% eye drops for the reduction of elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension. The approval date was September 22. OMLONTI is developed jointly by Santen and UBE.

Omidenepag isopropyl, the active pharmaceutical ingredient in OMLONTI, developed by UBE, is a relatively selective prostaglandin EP2 receptor agonist, which increases aqueous humor drainage through the conventional (or trabecular) and uveoscleral outflow pathways, and the only product with this pharmacological action. OMLONTI was launched in Japan as Eybelis ophthalmic solution 0.002% in November 2018, and was filed for marketing approval in Asian countries in stages. The product was released in five countries and regions beginning in February 2021.

OMLONTI was evaluated in three randomized and controlled clinical trials in subjects with open-angle glaucoma or ocular hypertension with average baseline IOP of 24-26 mm Hg. The double-masked treatment duration was three months in all three studies. The third study included a 9-month open-label treatment period following the 3-month double-masked treatment period.

In the three studies, IOP reductions were observed for all treatment arms. In the OMLONTI arm, the reduction in IOP ranged from 5-7 mm Hg across all three studies. The corresponding reductions for the timolol and latanoprost arms were 5-7 mm Hg and 6-8 mm Hg, respectively. Glaucoma causes damage to the optic nerve resulting in visual field loss, and remains a leading cause of irreversible blindness worldwide.

2 Since the disease is generally progressive, early detection and treatment to control the progression are crucial, and lowering IOP is the most effective means of avoiding damage to the optic nerve. The estimated number of patients globally in 2020 was 76 million, and it is expected to increase to 95 million by 2030. 3 Primary open-angle glaucoma is the most common type of glaucoma.

Ocular hypertension, which affects millions, can lead to glaucoma and vision loss if untreated.