Yes! The FDA has approved Omlonti (omidenepag isopropyl ophthalmic solution) 0.002% eye drops for reducing elevated IOP in patients with primary open-angle glaucoma or ocular hypertension.
What is Omlonti?
It's a relatively selective prostaglandin EP2 receptor agonist, which increases aqueous humor drainage through the trabecular and uveoscleral outflow pathways. Omlonti was launched in Japan as Eybelis ophthalmic solution 0.002% (once daily administration) in November 2018.
Remind me, what is an EP2 receptor?
It is a G-protein coupled receptor found in several ocular tissues, including nonpigmented ciliary epithelium, trabecular meshwork, and ciliary muscle tissues that are associated with aqueous humor dynamics. (via)
What did the clinical trials show?
Omlonti was evaluated in three randomized and controlled clinical trials in patients with open-angle glaucoma or ocular hypertension with average baseline IOPs of 24 mm Hg to 26 mm Hg.
The double-masked treatment duration was 3 months in all three studies. The third study included a 9-month open-label treatment period following the 3-month double-masked treatment period. In the three studies, IOP reductions were observed for all treatment arms.
In the Omlonti arm for each study, the reduction in IOP ranged from 5 mm Hg to 7 mm Hg. The corresponding reductions for the timolol and latanoprost arms were 5 mm Hg to 7 mm Hg and 6 mm Hg to 8 mm Hg, respectively.
Any adverse reactions?
According to the Eybelis prescribing information, the most frequently reported adverse reaction was ocular hyperemia, including conjunctival hyperemia (22.8%). Other side effects included macular edema in 5.2% of patients (found only in patients with IOLs) and iritis in 1.4% of patients.