A new hypotensive agent that could potentially enrich the armamentarium of glaucoma medications showed efficacy and safety in phase 2 trials.
Omidenepag isopropyl is a nonprostanoid selective EP2 receptor agonist that reduces IOP by increasing aqueous outflow via the conventional and uveoscleral pathways.
In three randomized phase 2 studies, two of which took place in the U.S. and one of which took place in Japan, it was tested at seven different concentrations in comparison with latanoprost and placebo. A total of 338 patients with primary open angle glaucoma (POAG) or ocular hypertension (OH) were included.
Following randomization, subjects received one drop of the assigned medication in both eyes once per day in the evening, for a time varying between 28 and 90 days, according to the study into which they were recruited.
Omidenepag isopropyl showed efficacy in lowering IOP at all doses, but the 0.002% concentration resulted in greater mean diurnal IOP reduction at all visits (17.36 + 1.9 mm Hg) and had comparable results to latanoprost. Maximum IOP reduction was achieved at week 1, showing an early onset of action, and was maintained for up to 3 months.
The most frequent adverse events were conjunctival hyperemia, photophobia and eye pain, which were all moderate in severity. A small mean increase in central corneal thickness (CCT) (less than 24 m) was observed in some eyes.
“The changes in CCT observed in these studies did not appear to be dose-dependent and were not associated with any safety concerns, for example, there were no reports of corneal edema in the biomicroscopy findings and no impact on visual acuity or IOP. The impact of the CCT increase on corneal endothelial cell count will be investigated in a long-term study,” the authors wrote.
Further investigation in phase 3 trials will be conducted using the omidenepag isopropyl 0.002% concentration. – by Michela Cimberle
Disclosure: The authors reported no relevant financial disclosures.