Roibeard O’hEineachain
Published: Thursday, September 30, 2021
New EP2 antagonist eye drop provides IOP reduction similar to prostaglandin-analogues. Roibeárd Ó hÉineacháin reports from the 9th World Glaucoma E-Congress.
A new non-prostaglandin eye drop formulation called omidenepag isopropyl (EYBELIS®, Santen) has an IOP-lowering effect comparable to that of latanoprost for primary open-angle glaucoma (POAG) and ocular hypertensive patients, but without the cosmetic side effects, said Makoto Aihara MD, PhD.
“Omidenepag isopropyl could be the new first-line drug for glaucoma,” he continued.
Dr Aihara noted that omidenepag isopropyl (OMDI) is a prodrug hydrolysed in the eye to its active form, omidenepag—a selective, non-prostaglandin, prostanoid EP2 agonist. Omidenepag has a novel mechanism of action that lowers IOP by increasing aqueous humour outflow through both uveoscleral and trabecular pathways.
Unlike prostaglandin F2α analogues currently in clinical use, omidenepag has no measurable effect on the FP receptor in the eye, eliminating the risk of FP-mediated adverse events such as eyelash growth and prostaglandin-associated periorbitopathy (PAP). OMDI has been approved for POAG treatment in Japan, Korea, and Taiwan, he noted.
Several trials have confirmed OMDI’s safety and efficacy. For example, in phases one and two of the multicentre randomised controlled trial, IOP decreased from 23.78mmHg to 17.81mmHg after four weeks of treatment with OMDI 0.002% in 94 POAG patients, and 23.40mmHg to 16.96 mmHg after the same length of treatment in 96 patients randomised to latanoprost.
Dr Aihara noted that OMDI’s side effect profile is different from latanoprost. The more common adverse events among patients receiving OMDI were conjunctival hyperaemia (24.5% versus 10.4%) and corneal thickening (11.7% versus 1.0%), whereas punctuate keratitis was less common (0% versus 7.3%) than in eyes treated with latanoprost.
A phase three study evaluating long-term IOP reduction achieved with OMDI in patients with POAG or OHT supported the study findings. It showed that after 52 weeks of treatment with OMDI 0.002%, mean IOP decreased by 2.4mmHg (19.5%) in 48 patients with a baseline IOP of 16mmHg to 22mmHg and 5.64mmHg (23%) in patients with baseline IOP of 22mmHg to 34mmHg.
There were no reports of cosmetic adverse events like PAP syndrome or increased pigmentation of the iris, eyelid, and eyelashes throughout the study. Moreover, in an ongoing study involving 12 POAG patients with PAP syndrome who were switched to OMDI 0.002% from a prostaglandin analogue, deepening of the upper eyelid sulcus improved in six patients, and a flattening of the lower eyelid bags improved in three after 12 months.
Makoto Aihara MD, PhD is Chair and Professor of Ophthalmology, University of Tokyo, Japan
aihara-tky@umin.ac.jp; macaihara1126@gmail.com
Tags: glaucoma
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