Efficacy and Safety of Omidenepag Isopropyl 0.002% Ophthalmic Solution: A Retrospective Analysis of Real-World Data in Japan

Abstract

Introduction: This study aimed to clarify the efficacy and safety of omidenepag isopropyl (OMDI) in a retrospective, real-world, multicenter setting. Methods: A retrospective medical chart review of patients with glaucoma and ocular hypertension receiving OMDI from November 2018 to November 2019 with at least 12 weeks of follow-up was conducted in 11 eye clinics in Japan. The participants were categorized into three therapy groups, designated the naı ¨ve monotherapy, switching monotherapy, and concomitant therapy groups. The main outcome measures were the change in intraocular pressure (IOP) at week 4 and week 12 after the initiation of OMDI treatment, and frequency of adverse drug reactions. Results: Data were collected from 827 patients. The baseline IOP in the naı ¨ve group was 16.6 ± 4.2 mmHg. The mean IOP reduction at week 4 and week 12 was -2.9 ± 3.2 mmHg (P \ 0.0001) and -2.5 ± 2.9 mmHg (P \ 0.0001), respectively. Eyes with baseline IOP less than 16 mmHg also showed a significant reduction of IOP of -1.4 ± 2.0 mmHg at week 12. OMDI significantly reduced IOP not only in eyes with primary open-angle glaucoma but also in eyes with primary angle-closure glaucoma and secondary glaucoma. In the switching monotherapy group, IOP did not change significantly after switching from most classes of medications to OMDI, but further IOP reduction was observed in the case of switching from beta-blockers to OMDI. The frequency of adverse drug reactions was 14.1% in all participants, and the most common adverse reaction was ocular hyperemia (7.6%). No serious and severe side effects were observed in this study. Conclusion: OMDI showed an IOP-lowering effect in eyes with various types of glaucoma and using various therapeutic regimens in realworld clinical practice. In addition, OMDI did not show any serious and severe side effects, suggesting the potential of OMDI as a first-line medicine for the treatment of glaucoma.

Steroid-Induced Ocular Hypertension in Mice Is Differentially Reduced by Selective EP2, EP3, EP4, and IP Prostanoid Receptor Agonists

“…More recently, a novel non-PG EP2 receptor-selective agonist, omidenepag isopropyl ester (OMDI), potently and efficaciously reduced IOP in rabbits, dogs, and lasered OHT Cynomolgus monkeys [ 73 ]. Importantly, OMDI potently and efficaciously lowered and controlled IOP as effectively as latanoprost in human subjects suffering from OHT, open-angle glaucoma (OAG), primary angle-closure glaucoma (PACG), and secondary glaucoma (see recent reviews [ 34 , 80 , 81 ]). Thus, it appears that EP2 receptor agonists can be useful in treating various forms of OHT induced by different mechanisms and under different experimental and clinical situations.…”

An Update on Pharmacotherapy of Glaucoma

“…Substitution with PGA or non-PGA drugs may be effective in lowering IOP in poor or non-responders [66,139]. OMPI is effective in NTG [140] and secondary glaucoma [141].…”

Recently Approved Drugs for Lowering and Controlling Intraocular Pressure to Reduce Vision Loss in Ocular Hypertensive and Glaucoma Patients

“…Clearly, the higher the baseline IOPs, the greater the efficacy of OMDI 0.002% ( Figure 15 B). More recent studies indicated that OMDI may also be therapeutically useful in Japanese patients with secondary glaucomas and primary angle-closure glaucoma ( Figure 16 ; [ 211 , 212 , 213 ]). This is where a relatively fast onset of action of OMDI may be beneficial, as identified from the monkey studies [ 127 , 187 , 188 ].…”

“…Various animal-based and clinical studies have also demonstrated that OMDI can be combined with other IOP-lowering drugs to obtain additional efficacy [ 187 , 207 , 208 , 214 ] ( Figure 13 and Figure 15 B). Such adjunctive therapy will prove useful for patients with many types of glaucoma [ 212 ]. Furthermore, recent clinical studies involving OMDI 0.002% demonstrated its beneficial ocular hypotensive properties in patients suffering from not only OHT and OAG, but it also lowered IOP significantly in NTG and ACG patients as well over a 4- week trial period ( Figure 16 ) [ 127 , 212 , 213 ].…”

“…Such adjunctive therapy will prove useful for patients with many types of glaucoma [ 212 ]. Furthermore, recent clinical studies involving OMDI 0.002% demonstrated its beneficial ocular hypotensive properties in patients suffering from not only OHT and OAG, but it also lowered IOP significantly in NTG and ACG patients as well over a 4- week trial period ( Figure 16 ) [ 127 , 212 , 213 ].…”