FDA Approves Omidenepag Isopropyl for Elevated Intraocular Pressure in Primary Open-Angle Glaucoma, Ocular Hypertension

The FDA has approved omidenepag isopropyl ophthalmic solution (Omlonti; Santen Inc and UBE Corporation) 0.002% eye drops to decrease elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension. This is the second medication from Santen indicated for patients with vision problems approved by the FDA in the past 15 months.

“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 a press 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 omidenepag isopropyl is a selective prostaglandin EP2 receptor agonist. The treatment increases aqueous humor drainage via the trabecular and uveoscleral outflow pathways. Omidenepag isopropyl is the only medication with this pharmacological action, according to the press release.

The approval of omidenepag isopropyl was based on 3 randomized, controlled clinical trials in patients with open-angle glaucoma or ocular hypertension with average baseline IOP of 24-26 mm Hg. All of the studies used a 3-month double-masked treatment duration. Additionally, the third study included a 9-month, open-label treatment period after the 3-month double-masked treatment period.

The researchers observed IOP reductions across all of the treatment arms in the 3 studies. In the omidenepag isopropyl ophthalmic solution cohorts for all 3 studies, decreased IOP ranged from 5-7 mmHg. Corresponding reductions in the timolol and latanoprost cohorts 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, in a press release. “It also represents our first glaucoma offering in the US. We are pleased to provide doctors and patients in the US with a new option to help control IOP for the more than 3 million Americans affected by glaucoma or ocular hypertension.”

Twelve clinical studies have evaluated the safety of omidenepag isopropyl, including 10 that evaluated safety in QD dosing. These trials found that omidenepag isopropyl to be safe and well tolerated in 1111 adult patients with open-angle glaucoma or ocular hypertension, as well as in 6 pediatric patients with juvenile open-angle glaucoma. Adverse event risks observed with use of omidenepag isopropyl include macular edema, including cystoid macular edema, in patients with aphakia, pseudophakia, or other risk factors for macular edema; ocular inflammation; the potential for increased eye pigmentation; and eyelash changes.

“We are very pleased that this ophthalmic solution has been approved for glaucoma in the US, following approvals in Japan and Asia,” said Yoichi Funayama, senior executive officer and general manager of the Pharmaceutical Division, UBE Corporation, in a press release. “We have high expectations that omidenepag isopropyl will provide a new treatment option for more patients suffering from glaucoma and ocular hypertension through Santen.”

Reference

Santen and UBE Received FDA Approval for OMLONTI® (Omidenepag Isopropyl Ophthalmic Solution) 0.002% for the Reduction of Elevated Intraocular Pressure in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension. Santen. News release. September 26, 2022. https://www.businesswire.com/news/home/20220926005533/en/Santen-and-UBE-Received-FDA-Approval-for-OMLONTI%C2%AE-Omidenepag-Isopropyl-Ophthalmic-Solution-0.002-for-the-Reduction-of-Elevated-Intraocular-Pressure-in-Patients-with-Primary-Open-Angle-Glaucoma-or-Ocular-Hypertension