FDA Approves Omlonti for Glaucoma

The FDA has approved Omlonti (omidenepag isopropyl) eye drops for the reduction of elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension. Omlonti, developed jointly by Japanese-based Santen Pharmaceutical and UBE, is a relatively selective prostaglandin EP2 receptor agonist.

Glaucoma causes damage to the optic nerve and remains a leading cause of irreversible blindness worldwide; it is estimated to impact about 80 million people worldwide. Primary open angle glaucoma is the predominant subtype of glaucoma. Increased intraocular pressures is an important risk factor for glaucoma.

“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,” Peter Sallstig, chief medical officer of Santen, said in a press release. “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 3 million Americans affected by glaucoma or ocular hypertension.”

The approval was based on data from 12 clinical studies conducted in multiple global locations. A U.S. phase 3 study confirmed Onlonti to be non-inferior to timolol, the standard of care. Two different phase 3 studies conducted in Japan and Asia showed Onlonti to be non-inferior to latanoprost.

The FDA had accepted the companies’ an NDA submission in June 2022. Previously, the FDA had issued a complete response because of deficiencies at contract manufacturing facilities that were not compliant with good manufacturing practice regulations.

The therapy was launched in Japan as Eybelis ophthalmic solution 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.