OMDI shows potential as first-line treatment for glaucoma in real-world trial

In a retrospective review of real-world data from Japan, omidenepag isopropyl 0.002% ophthalmic solution (OMDI) demonstrated an intraocular pressure (IOP)-lowering effect in eyes with different types of glaucoma, without severe or serious adverse effects.

Launched in Japan in 2018, OMDI was the first EP₂ receptor agonist to obtain regulatory approval for treating glaucoma and ocular hypertension (OH). However, given reports of rare but serious adverse events (eg, cystoid macular oedema [CME], decreased visual acuity) tied to OMDI use, further safety data are warranted. [Expert Rev Ophthalmol 2021;16:243-250]

“In addition, critical information about the safety and efficacy of OMDI in various clinical situations (ie, efficacy in each type of glaucoma, efficacy after switching from other antiglaucoma drugs, safety in combination therapy), is still limited,” said the researchers.

This review comprised 698 eligible participants (mean age 61.7 years, 60 percent female) with glaucoma and OH who were on OMDI treatment from November 2018 to November 2019, with at least 12 weeks of follow-up. They were categorized into three* therapy arms: naïve monotherapy, switching monotherapy, and concomitant therapy** (n=341, 222, and 135, respectively). Most participants (85 percent) had primary open-angle glaucoma/normal tension glaucoma (POAG/NTG). Other diagnoses were primary angle-closure glaucoma (PACG), secondary glaucoma, and OH. [Adv Ther 2022;39:2085-2095]

 

Naïve monotherapy group

Mean IOP decreased from 16.6 mm Hg at baseline to 13.9 and 14.0 mm Hg at the respective 4- and 12-week timepoints (p<0.0001 for both).

In patients with baseline IOP <16 mm Hg, mean IOP dropped from 13.4 mm Hg at baseline to 11.8 and 12.0 mm Hg at 4 and 12 weeks, respectively (p<0.0001 for both). “[This implies] that OMDI reduces IOP even in patients with low baseline IOP,” the researchers noted.

Moreover, week 4 saw significant mean IOP reductions with OMDI in eyes with POAG/NTG (–2.7 mm Hg; p<0.0001), PACG (–1.7 mm Hg; p=0.036), secondary glaucoma (–4.0 mm Hg; p=0.047), and OH (–7.6 mm Hg; p=0.009). These results reflect the efficacy of OMDI for various types of glaucoma.

 

Switching monotherapy group

The most commonly used agents prior to OMDI treatment was prostaglandins, followed by ion channel openers, prostaglandins/beta-blocker fixed-combinations, beta-blockers, CAI***/beta-blocker fixed-combinations, and alpha-2 receptor stimulants.

No significant IOP changes were seen after switching from most drug classes to OMDI, except for those who switched from beta-blockers to OMDI (mean change, –1.2 mm Hg; p=0.047 [week 4] and –2.3 mm Hg; p=0.002 [week 12]).

 

Safety

Fourteen percent of participants in the safety analysis set reported a total of 153 adverse reactions, the most frequent being ocular hyperaemia (8 percent). Rates of eye itching and blurred vision were low (2 percent and 1 percent, respectively). There were no serious and severe side effects reported. Contrary to what was reported in another study, there were no cases of CME and uveitis. [JPN J Ophthalmol 2021;65:810-819]

“[T]he low frequency of adverse reactions … may be related to the proper and careful use of [OMDI] in the real world,” the researchers remarked.

 

Further trials warranted

“This real-world survey provided several additional pieces of information about the efficacy and safety of OMDI, which have not been clarified in previous trials … [Our findings suggest] that OMDI can be a first-line medicine for the treatment of glaucoma,” the researchers concluded.

Given the short observation period, longer-term trials are warranted to validate the findings. “[Although] our results suggest the favourable effect of OMDI regardless of glaucoma type … it is necessary to clarify the long-term efficacy and safety profile of OMDI for each type of glaucoma in the future,” they added.