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Omlonti (omidenepag isopropyl ophthalmic solution) 0.002%, is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Omlonti (omidenepag isopropyl ophthalmic solution) 0.002%, is a relatively selective prostaglandin E2 (EP2) receptor agonist, indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ( 1 )

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Pigmentation ( 5.1 ) Eyelash changes ( 5.2 ) Ocular Inflammation ( 5.3 ) Macular Edema ( 5.4 ) 5.1 Pigmentation Omlonti (omidenepag isopropyl ophthalmic solution) 0.002%, is a prodrug of omidenepag, a relatively selective EP2 receptor agonist. Pigmentation is expected to increase as long as omidenepag isopropyl ophthalmic solution is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of Omlonti, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes are likely to be reversible in most patients. Patients who receive prostaglandin analogs, including Omlonti, should be informed of the possibility of increased pigmentation, including permanent changes. The long-term effects of increased pigmentation are not known. Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with Omlonti (omidenepag isopropyl ophthalmic solution), 0.002% can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly [see Patient Counseling Information (17) ] . 5.2 Eyelash Changes Omlonti may …

8.1 Pregnancy Risk Summary There are no available data on the use of Omlonti in pregnant women. In animal reproduction studies, subcutaneous administration of omidenepag isopropyl to pregnant rabbits throughout the period of organogenesis produced fetal skeletal anomalies at a dose of 24 times the clinical dose, based on estimated plasma C max . Omidenepag isopropyl was not teratogenic in rats when administered subcutaneously at 1 mg/kg/day, 2,452 times the clinical dose, based on estimated plasma C max (see Data ) . Data Animal Data An embryofetal development study was conducted in pregnant rabbits administered omidenepag isopropyl once daily by subcutaneous injection at 0.008, 0.08, or …