The Food and Drug Administration (FDA) has approved Omlonti® (omidenepag isopropyl ophthalmic solution) 0.002% for the reduction of elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension.
Omlonti is a relatively selective prostaglandin E2 (EP2) receptor agonist designed to increase aqueous humor drainage through the conventional (or trabecular) and uveoscleral outflow pathways. The approval was based on data from 3 randomized controlled clinical trials in patients with open-angle glaucoma or ocular hypertension with an average baseline IOP of 24 to 26mmHg.
The double-masked treatment duration was 3 months in all 3 studies. The third study included a 9-month open-label treatment period following the 3-month double-masked treatment period. Across all 3 studies, treatment with omidenepag resulted in IOP reduction ranging from 5 to 7 mmHg compared with 5 to 7 mmHg with timolol and 6 to 8 mmHg with latanoprost.
The most common adverse reactions reported with omidenepag were conjunctival hyperemia, photophobia, vision blurred, dry eye, instillation site pain, eye pain, ocular hyperemia, punctate keratitis, headache, eye irritation, and visual impairment.
Omlonti is supplied as a 2.5mL sterile solution in 5mL bottles; each mL contains 0.02mg of omidenepag isopropyl.
- 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. News release. Santen Inc. and UBE Corporation. Accessed 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
- Omlonti. Package insert. Santen Inc; 2022. Accessed September 26, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215092s000lbl.pdf