Efficacy and Patient Tolerability of Omidenepag Isopropyl in the Treatment of Glaucoma and Ocular Hypertension

Abstract

Current therapeutic approaches for glaucoma aim to reduce intraocular pressure (IOP), which is the only available and reliable strategy proven to control the risk of disease development and progression. Omidenepag isopropyl (OMDI) is a novel topical ocular hypotensive agent that was launched onto the market for the treatment of glaucoma and ocular hypertension (OHT). After topical instillation and during corneal penetration, OMDI is converted into the active metabolite omidenepag (OMD), which behaves as a non-prostaglandin, selective E-prostanoid subtype 2 (EP2) receptor agonist. The topical administration of 0.002% OMDI once-daily (QD) possesses a 20–35% IOP-lowering effect, comparable to that of prostaglandin analogs targeting F-prostanoid (FP) receptor QD, which are the current first-line for pharmaceutical reduction of IOP. However, the mechanism of action and adverse events (AEs) of OMDI are different from those of FP receptor agonists. OMDI reduces IOP by enhancing both conventional trabecular and uveoscleral outflow facilities without complications of prostaglandin-associated periorbitopathy (PAP) seen with FP receptor agonists. Moreover, OMDI was also effective and well-tolerated in non-/poor responders to latanoprost and showed a stable IOP-lowering effect for one year, and its concomitant use with timolol enhanced the IOP-lowering effect. OMDI demonstrated acceptable safety and tolerability with good adherence and can be used in almost every patient. However, OMDI has some AEs such as conjunctival hyperemia, corneal thickening, macular edema/cystoid macular edema and ocular inflammation. Moreover, OMDI is contraindicated in patients who are allergic to the product, in aphakic or pseudophakic eyes, and in combination with tafluprost eye drops. If used appropriately in the right patients, OMDI could be an effective treatment option for glaucoma and OHT as a first-line alternative to FP agonists. Here, we summarize the results of clinical studies of OMDI and discuss its efficacy and patient tolerability in glaucoma and OHT in this review.

Nation-Wide Analysis of Glaucoma Medication Prescription in Fiscal Year of 2019 in Japan

“…OMDI 0.002% was non-inferior to latanoprost 0.005% in reducing IOP in glaucoma patients [ 27 ], therefore has been used as a first-line medication. Because of the possible risk of macular edema, OMDI is contraindicated in patients with pseudophakic eyes [ 28 ]. This is a possible explanation of the unique distribution of PGEP 2 .…”

“…This is a possible explanation of the unique distribution of PGEP 2 . OMDI reduces IOP by enhancing both conventional trabecular and uveoscleral outflow facilities without prostaglandin-associated periorbitopathy (PAP) seen with PGF 2α [ 28 , 29 ]. By switching from PGF 2α to OMDI, signs of PAP were improved within 3 months after the switching [ 30 , 31 ].…”

Influence of 0.002% Omidenepag Isopropyl on Intraocular Pressure and the Cornea in Normal Tension Glaucoma

“…35 The incidences of OMDI-related adverse effects typically reported in clinical studies have been conjunctival hyperemia (19.7%), corneal thickening (5%), macular edema (4.4%), ocular pain (3.6%), glare (3.3%), blurred vision (1.7%), and anterior chamber inflammation (1.4%). 36 Hyperemia is a known side effect of PG analogs, occurring immediately following administration and disappearing after several hours. 37 OMDI, a PGE2 agonist, is also a kind of PG analog, so it is reasonable to assume that a similar pattern would be observed.…”

A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2022

“…It is a relatively selective agonist of the prostaglandin E 2 (EP2) receptor approved to reduce intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Clinical trials have demonstrated that omidenepag reduces intraocular pressure by enhancing outflow without complications (Aihara et al 2021 ; Matsuo et al 2022 ). The most frequent adverse reactions are conjunctival hyperemia, photophobia, vision blurred, dry eye, instillation site pain, and visual impairment.…”