Santen and UBE Corp. today that the FDA approved Omlonti (omidenepag isopropyl ophthalmic solution) 0.002% eye drops for the reduction of elevated 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, which was developed jointly by Santen and 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.
“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 glaucoma or ocular hypertension,” Peter Sallstig, Chief Medical Officer of Santen, said in a company news release.
“UBE Corporation is committed to working on new drug discoveries on a daily basis with the aim of providing patients with more treatment options for diseases with high unmet needs," said Yoichi Funayama, Senior Executive Officer and General Manager of the Pharmaceutical Division, UBE Corporation. “We are very pleased that this ophthalmic solution has been approved for glaucoma in the U.S., following approvals in Japan and Asia. We have high expectations that omidenepag isopropyl will provide a new treatment option for more patients suffering from glaucoma and ocular hypertension through Santen.”
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 3 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.
“Treatments that focus on IOP reduction help to slow or prevent further loss of vision for those with glaucoma or ocular hypertension. However, not all patients respond to the same treatments, and some may not have successful outcomes,” Jason Bacharach, MD, Medical and Research Director at North Bay Eye Associates, said in the news release. “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.”