Santen Inc., the U.S. subsidiary of Santen Pharmaceutical Co., Ltd. (Santen), and UBE Corporation (UBE) announced FDA approval of OMLONTI® (omidenepag isopropyl ophthalmic solution) 0.002% eye drops.
- Omlonti is used 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, indicated for the reduction of elevated intraocular pressure (IOP) and the recommended dosage is one drop in the affected eye(s) once daily in the evening.
- The risks identified with instillation of Omlonti include macular edema, including CME, in patients with aphakia, pseudophakia, or other risk factors for macular edema; ocular inflammation; the possibility of increased eye pigmentation; and eyelash changes.
- The product was released in five countries and regions beginning in February 2021.