<p>Short-Term Efficacy and Safety of Omidenepag Isopropyl in Patients with Normal-Tension Glaucoma</p>

Abstract

To retrospectively evaluate the short-term efficacy of omidenepag isopropyl (EYBELIS 0.002%) by assessing its intraocular pressure (IOP)-lowering capability and safety in patients with normal-tension glaucoma (NTG). Patients and Methods: Fifty-four NTG patients (54 eyes) who were newly administrated with omidenepag isopropyl were enrolled in the study. The subjects comprised 22 men and 32 women, and the mean age of the subjects was 55.0 ± 14.1 years. The mean deviation value using the Humphrey visual field test program (30-2 SITA Standard) was −5.03 ± 3.38 dB. The following data were retrieved from the medical records and used for retrospective analyses: IOP at baseline 1-2 months and 3-4 months after administration. The frequency of non-responder patients who had less than 10% IOP reduction was evaluated. Patients were observed for adverse reactions and dropouts at each time point. Results: IOP at baseline, after 1-2 months and after 3-4 months was 15.7 ± 2.6 mmHg, 13.5 ± 2.3 mmHg, and 13.6 ± 2.4 mmHg, respectively. There was a significant decrease in IOP after administration (p<0.0001). Eleven patients (22.4%) were non-responders. Adverse reactions occurred in 4 patients (7.4%), including conjunctival hyperemia in 3 patients (after 1 week, 2 weeks, and 1 month, respectively) and eye pain in 1 patient (after 1 month). Five patients (9.3%) dropped out of the study because of an adverse reaction in 3 patients, insufficient IOP reduction in 1 patient, and discontinuation of follow-up of 1 patient at our institution. Conclusion: After administration of omidenepag isopropyl, IOP in patients with NTG was significantly decreased. However, adverse reactions occurred in 7.4% of patients.

Topical Medication Therapy for Glaucoma and Ocular Hypertension

“…OMDI has better safety than latanoprost ( Aihara et al, 2019 ). The ocular AEs induced by OMDI is mild or moderate, and the most frequently reported are conjunctival hyperemia, photophobia, and eye pain ( Aihara et al, 2020a ; Inoue et al, 2020a ; Aihara et al, 2020b ). Conjunctival hyperemia is dose-dependent ( Aihara et al, 2019 ), and most frequently observed in small vessels (51%) in OMDI-treated eyes, and in both large and small vessels (81%) in ripasudil-treated eyes ( Terao et al, 2020 ).…”

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

“…Omidenepag isopropyl (OMDI) was launched in Japan in 2018 as the first EP 2 receptor agonist to obtain regulatory approval for the treatment of glaucoma and ocular hypertension. OMDI exhibited an IOP-lowering effect that was not inferior to the FP receptor agonist latanoprost, without producing prostaglandinassociated periorbitopathy (PAP) which adversely affects adherence to therapy [6][7][8][9][10]. On the other hand, since OMDI caused rare but serious adverse events such as cystoid macular edema (CME) and decreased visual acuity in a previous study [11], further information on safety under clinical use is required.…”

Normal‐tension glaucoma: Current concepts and approaches‐A review

“…However, adverse drug reactions, including conjunctival hyperaemia and eye pain, occurred in 7.4%. 127 This drug has not yet been approved for use in pseudophakic patients, because of the risk of cystoid macular edema. Further studies are needed.…”