Ocular Hypertension

Glaucoma is the leading cause of irreversible blindness worldwide, affecting more than 64 million people aged 40-80 years. Glaucoma can arise through various etiologies; but vision loss is ultimately due to optic nerve damage and the progressive death of retinal ganglion cells. Intraocular pressure (IOP); which becomes elevated owing to abnormally high resistance to trabecular (conventional) outflow; is currently the only modifiable risk factor for disease progression in patients with glaucoma or ocular hypertension.

Mean intraocular pressure

Ophthalmic solution of Netarsudil (0.02%; once daily) significantly reduced mean intraocular pressure (IOP); among patients with open-angle glaucoma or ocular hypertension, according to a study published in the August issue of the American Journal of Ophthalmology. In a double-masked, randomized, phase 3, noninferiority study; Albert S. Khouri, M.D., from the Rutgers New Jersey School of Medicine in Newark, and colleagues randomly assigned patients with open-angle glaucoma or ocular hypertension(unmedicated baseline IOP >20 to <30 mm Hg at 8:00 a.m.) to either netarsudil ophthalmic solution 0.02 % once daily (186 patients); or timolol ophthalmic solution 0.5 % twice daily (186 patients).

However, the researchers found that daily netarsudil was noninferior to twice-daily timolol; with a mean treated IOP range from 16.3 to 17.9 mm Hg for netarsudil and 16.7 to 17.6 mm Hg for timolol (mean reductions from baseline of 3.9 to 4.7 mm Hg and 3.8 to 5.2 mm Hg, respectively). Netarsudil demonstrated noninferiority to timolol in patients; with baseline IOP <27 mm Hg and <30 mm Hg in prespecified secondary analyses. For netarsudil, the IOP-lowering effects sustained during six months of treatment.

Glaucoma or ocular hypertension

Neither drug had treatment-related serious adverse events. For timolol, there statistically significant reductions in mean heart rate at all study visits. However, among netarsudil-treated patients, the most frequent ocular adverse event was conjunctival hyperemia (47.9 %), which was mostly mild. However, the discontinuation rate for netarsudil was higher than for timolol, but was similar to that reported in registration studies for other approved glaucoma products.

“But in conclusion, netarsudil [once daily] is effective at lowering IOP in patients with open-angle glaucoma or ocular hypertension; with tolerable ocular adverse events,” the authors write. The IOP-lowering efficacy of netarsudil QD is noninferior to that of timolol BID; is consistent across lower and higher baseline pressures, and is sustained over 6 months of treatment. however, as a new class of treatment with a novel mechanism of action, netarsudil QD has the potential to be used both as a single agent; and as an adjunct to currently used IOP-lowering treatments. Several authors disclosed financial ties to pharmaceutical companies; including Aerie Pharmaceuticals, which manufactures netarsudil and funded the study.