FDA Approves Omidenepag Isopropyl Ophthalmic Solution for Reduction of Elevated IOP

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The 0.002% eye drops were designated for the reduction of elevated IOP in patients with primary open-angle glaucoma or ocular hypertension.

The US Food and Drug Administration (FDA) has approved omidenepag isopropyl ophthalmic solution (OMLONTI®) 0.002% eye drops for the reduction of elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension.

The approval was granted to Santen Inc. and UBE Corporation, who developed the product jointly, on September 22. It is the second FDA-approved product from Santen in the last 15 months for patients in the US with vision problems.

“Treatments that focus on IOP reduction help to slow or prevent further loss of vision for those with glaucoma or ocular hypertension,” said Jason Bacharach, MD, Medical and Research Director at North Bay Eye Associates, Inc in the release. “However, not all patients respond to the same treatments, and some may not have successful outcomes. The approval of omidenepag isopropyl ophthalmic solution 0.002% provides doctors with another safe and effective option to use when treating patients with these sight-threatening conditions.”

The active pharmaceutical ingredient in the solution, omidenepag isopropyl, is a relatively selective prostaglandin EP2 receptor agonist. It increases aqueous humor drainage through the trabecular and uveoscleral outflow pathways and is the only product with this pharmacological action, according to the release.

The ophthalmic solution was evaluated in three randomized and controlled clinical trials in patients with open-angle glaucoma or ocular hypertension with average baseline IOP of 24-26 mm Hg. All three studies had a double-masked treatment duration of three months, with the third study including a 9-month open-label treatment period following the 3-month double-masked treatment period.

In all three studies, the findings reported IOP reductions for all treatment arms. In the omidenepag isopropyl ophthalmic solution arm, the reduction in IOP ranged from 5 - 7 mmHg across all three studies. Corresponding reductions for the timolol and latanoprost arms were 5-7 mm Hg and 6 - 8 mmHg, respectively.

“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,’” Peter Sallstig, Chief Medical Officer of Santen. “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 glaucoma or ocular hypertension.”

The ophthalmic solution was previously launched in Japan as Eybelis® ophthalmic solution 0.002% in November 2018. The product was released in five Asian countries and regions beginning in February 2021.

“We are very pleased that this ophthalmic solution has been approved for glaucoma in the U.S., following approvals in Japan and Asia,” said Yoichi Funayama, Senior Executive Officer and General Manager of the Pharmaceutical Division, UBE Corporation. “We have high expectations that omidenepag isopropyl will provide a new treatment option for more patients suffering from glaucoma and ocular hypertension through Santen.”