Santen Inc. and UBE Corp. announced that the U.S. Food and Drug Administration has approved Omlonti eye drops for the reduction of elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension.
“Glaucoma prevalence is increasing as the global population ages. Supporting patients by protecting vision across the continuum of clinical care in glaucoma is a significant aim for Santen to reduce the social and economic opportunity loss of people around the world caused by eye conditions,” said Peter Sallstig, chief medical officer of Santen. “This approval is an important milestone in our ambition to tackle unmet needs in eye health and advances our goal of realization of “Happiness with Vision. It also represents our first glaucoma offering in the U.S. We are pleased to provide doctors and patients in the U.S. with a new option to help control IOP for the more than three million Americans affected by glaucoma1 or ocular hypertension.”
Omlonti was developed jointly by Santen and UBE. Omidenepag isopropyl, the active pharmaceutical ingredient in the drug, 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,” according to a press release.
The approval date was Sept. 22.
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.
Santen Inc. is the U.S. subsidiary of Santen Pharmaceutical Co. Ltd., of Japan.