OmlontiGlaucoma and ocular hypertension
New molecular entity
Development and Regulatory status
Sep 22FDA approves omidenepag isopropyl 0.002% eye drops for the reduction of elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. Developed jointly by Santen and UBE, Omlonti was launched in Japan as Eybelis in Nov 18, and was filed for marketing approval in Asian countries in stages. The product was released in five countries and regions beginning in Feb 21 [2,3].
A first-in-class, relatively selective prostaglandin E2 (EP2) receptor agonist that increases aqueous humour drainage through the conventional (or trabecular) and uveoscleral outflow pathways. Presented as a 0.002% ophthalmic solution.
Ocular hypertension affects 3-5% of the population over 40 years of age but only a small proportion of these people develop glaucoma. If glaucoma is completely untreated, progression to severe sight impairment typically takes 25-70 years from onset .
Glaucoma and ocular hypertension
Trial or other data
Omlonti was evaluated in three randomised controlled clinical trials in subjects with open-angle glaucoma or ocular hypertension with average baseline IOP of 24-26 mm Hg. The double-masked treatment duration was three 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, the reduction in IOP ranged from 5-7 mm Hg across all three studies. The corresponding reductions for the timolol and latanoprost arms were 5-7 mm Hg and 6-8 mm Hg, respectively .