■ Santen Inc. and UBE Corporation announced FDA approval for their jointly developed omidenepag isopropyl ophthalmic solution 0.002% — Omlonti — to treat elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG). The relatively selective prostaglandin EP2 receptor agonist is the only product available that increases aqueous humor drainage through the trabecular and uveoscleral outflow pathways, the company said in a news release. First launched as Eybelis in Japan in November 2018, the drug was released in 5 countries and regions beginning in 2021. Omlonti represents Santen’s first glaucoma offering in the United States.

The agent was evaluated in 3 randomized, controlled trials in subjects with OAG or ocular hypertension and average baseline IOP of 24 mmHg to 26 mmHg. The double-masked portion was 3 months in the 3 studies, and the third study included a 9-month open-label period. IOP reductions were observed for all arms in all studies. Omlonti-assigned subjects had IOP reduction ranging from 5 mmHg to 7 mmHg vs timolol and latanoprost arms with 5 mmHg to 7 mmHg and 6 mmHg to 8 mmHg, respectively.