Omidenepag isopropyl safe, effective for POAG
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Use of omidenepag isopropyl was just as effective and safe as latanoprost in treating primary open-angle glaucoma in Japanese patients, according to findings published in the American Journal of Ophthalmology.
Makoto Aihara, MD, PhD, of the University of Tokyo, Bunkyo-ku’s department of ophthalmology, and colleagues analyzed data from a phase 3, randomized, investigator-masked, active-controlled, parallel-group, noninferiority study.
They stratified patients into groups receiving omidenepag isopropyl (OMDI) 0.002% or 0.005% once daily during a 4-week period. Investigators measured IOP at 9 a.m., 1 p.m. and 5 p.m. at weeks 1, 2 and 4.
Change in mean diurnal IOP at week 4 from baseline served as the primary endpoint, the researchers wrote. The noninferiority margin for OMDI vs. latanoprost was 1.5 mm Hg.
Of 190 patients, 189 had at least one post-baseline IOP measurement. At baseline, patients receiving OMDI or latanoprost had a mean diurnal IOP of 23.78 mm Hg and 23.4 mm Hg, respectively.
At week 4, least-squares mean reduction in IOP from baseline for OMDI was –5.93 mm Hg compared with –6.56 mm Hg for latanoprost (95% CI, 0.01–1.26), the researchers wrote.
The most frequently reported adverse events included conjunctival hyperemia (24.5% for OMDI vs. 10.4% for latanoprost) and corneal thickening (11.7% vs. 1%). Investigators observed punctate keratitis only in the latanoprost group (5.2%).
“OMDI had an acceptable safety rating and tolerability profile, as no serious treatment-related adverse events were reported, and there were no discontinuations related to the treatment,” the researchers wrote. “OMDI could, therefore, be considered a candidate for first-line treatment of glaucoma and (ocular hypertension).”
Perspective
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Carl H. Jacobsen, OD, FAAO
Prostaglandin analogs (PGA) have become our first-line topical glaucoma treatment for good reason. They are efficacious, easy to use and have an excellent safety profile. However, when I personally needed a topical drop for my ocular hypertension, what did I reach for? It wasn’t latanoprost. The fact is, I’ve grown to dislike PGAs for their appearance altering effects. Doe-like lashes, dark adnexa and sunken eyeballs just aren’t a good look. PGAs shouldn’t be used monocularly and should be used with care (and full disclosure) for patients where the appearance altering effects could be more troubling. That’s right, patients like me…
Enter OMDI. It is a selective prostaglandin EP2 receptor agonist with a non-prostaglandin structure that will be marketed by Santen under the trade name Eybelis. Conjunctival hyperemia is the primary side effect, and it lowers IOP by increasing both trabecular and uveoscleral outflow. Importantly, this medication has not been associated with the aforementioned PGA-associated changes.
These phase 3 clinical trial data are exciting. It appears that OMDI has PGA-like ease of use, efficacy and safety profile without the deleterious effects on appearance. In proving noninferiority to our gold standard latanoprost, OMDI is poised to become our new first-line topical treatment for glaucoma. I can’t wait to get some samples.
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