Omidenepag Isopropyl Ophthalmic Solution 0.002%: First Global Approval

Omidenepag isopropyl ophthalmic solution 0.002% (EYBELIS (R)) is a selective prostaglandin E2 receptor 2 agonist with a non-prostaglandin structure that is being developed by Ube Industries and Santen Pharmaceutical in Japan, Singapore and the USA for the treatment of glaucoma and ocular hypertension. Based on results from phase III trials, omidenepag isopropyl ophthalmic solution 0.002% received approval in Japan in September 2018 for this indication. This article summarizes the milestones in the development of omidenepag isopropyl ophthalmic solution 0.002% leading to this first global approval for the treatment of glaucoma and ocular hypertension.